UC-1800 Automatic Urine Analyzer, URIT 11FA Urine Reagent Strips, URIT 12FA Urine Reagent Strips

K232317 · Urit Medical Electronic Co., Ltd. · JIO · Apr 26, 2024 · Hematology

Device Facts

• Record ID: K232317
• Device Name: UC-1800 Automatic Urine Analyzer, URIT 11FA Urine Reagent Strips, URIT 12FA Urine Reagent Strips
• Applicant: Urit Medical Electronic Co., Ltd.
• Product Code: JIO · Hematology
• Decision Date: Apr 26, 2024
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 864.6550
• Device Class: Class 2

Intended Use

The UC-1800 Automatic Urine Analyzer is automated instrument, which is intended for professional, in vitro diagnostic use only. Depending on the reagent strips being used, the instruments perform semi-quantitative detection of the following analytes in urine: ascorbic acid, microalbumin, leukocytes, creatinine, ketone, urobilinogen, bilirubin, glucose, protein, specific gravity, blood and pH in urine and for qualitative determination of nitrite in urine. The urine hydrometer (optional) can determine the color and turbidity of urine. Test results may provide information regarding the status of carbohydrate metabolism, kidney and liver function, acid-base balance and bacteriuria. The URIT 11FA urine reagent strips provide semi-quantitative tests for ascorbic acid, leukocytes, ketone, urobilinogen, bilirubin, glucose, protein, specific gravity, blood and pH in urine and for qualitative determination of nitrite in urine. The URIT 11FA urine reagent strips are for use with the UC-1800 Automatic Urine Analyzer and are for professional, in vitro diagnostic use only. Test results may provide information regarding the status of carbohydrate metabolism, kidney and liver function, acid-base balance and bacteriuria. The URIT 12FA urine reagent strips provide semi-quantitative tests for microalbumin, leukocytes, creatinine, ketone, urobilinogen, bilirubin, glucose, protein, specific gravity, blood and pH in urine and for qualitative determination of nitrite in urine. The URIT 12FA urine reagent strips are for use with the UC-1800 Automatic Urine Analyzer and are for professional, in vitro diagnostic use only. Test results may provide information regarding the status of carbohydrate metabolism, kidney and liver function, acid-base balance and bacteriuria.

Device Story

UC-1800 Automatic Urine Analyzer uses URIT 11FA/12FA reagent strips for urinalysis; processes human urine samples. System automates sample transport, aspiration, dropping, rinsing, strip feeding, and measurement. Measurement uses reflective photoelectric colorimetry via CIS (contact image sensor) scanning; turbidity module uses light scattering at 90°; color detected via professional color recognition sensor. Device prints results via internal/external printer. Used in clinical laboratories by professional staff. Output provides semi-quantitative/qualitative analyte concentrations; aids clinical assessment of metabolic, renal, and hepatic status. Includes optional hydrometer for physical properties.

Clinical Evidence

No clinical studies were performed. Substantial equivalence is supported by bench testing, including precision (repeatability/reproducibility), linearity, analytical sensitivity, analytical specificity (interference testing), carryover, and method comparison studies against predicate devices using 1000 clinical samples.

Technological Characteristics

Reflectance photometry and CIS image scanning. Light source: LED. Analyte detection via dry chemistry reagent blocks. Connectivity: Built-in/external printer. Calibration: White calibration strip and specific gravity/turbidity/color calibration products. Standards: IEC 61010-1, IEC 61326-1/2-6, IEC 60601-1, CLSI EP06/EP07/EP09c/EP17-A2.

Indications for Use

Indicated for professional, in vitro diagnostic use in clinical laboratories for semi-quantitative or qualitative detection of analytes in human urine (ascorbic acid, microalbumin, leukocytes, creatinine, ketone, urobilinogen, bilirubin, glucose, protein, specific gravity, blood, pH, nitrite, color, and turbidity) to assess carbohydrate metabolism, kidney/liver function, acid-base balance, and bacteriuria.

Regulatory Classification

Identification

An occult blood test is a device used to detect occult blood in urine or feces. (Occult blood is blood present in such small quantities that it can be detected only by chemical tests of suspected material, or by microscopic or spectroscopic examination.)

Special Controls

*Classification.* Class II (special controls). A control intended for use with an occult blood test is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 864.9.

Predicate Devices

• Uritest 500B Urine Analyzer (K082811)
• Uritest 50 Urine Analyzer (K082811)
• Uritest 10G Urine Reagent Strips (K082811)
• Uritest 11G Urine Reagent Strips (K082811)
• Mission® U120 Ultra Urine Analyzer (K142391)
• Mission® Urinalysis Reagent Strips (Microalbumin/Creatinine) (K142391)
• Mission® Liquid Urine Controls (K142391)
• Mission® Liquid Diptube Urine Controls (K142391)
• AUTION MAX AX-4030 Urinalysis System (K093098)

Submission Summary (Full Text)

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FDA U.S. FOOD & DRUG ADMINISTRATION

April 26, 2024

URIT Medical Electronic Co., Ltd.
c/o Dylan Wu, Consultant
Shanghai SUNGO Management Consulting Co., Ltd.
Room 1401, Dongfang Building, 1500# Century AVE
Shanghai 200122, China

Re: K232317

Trade/Device Name: UC-1800 Automatic Urine Analyzer, URIT 11FA Urine Reagent Strips, URIT 12FA Urine Reagent Strips
Regulation Number: 21 CFR 864.6550
Regulation Name: Occult Blood Test
Regulatory Class: Class II
Product Code: JIO, JIL, JFY, CDM, CEN, JIN, JJB, JMT, LJX, JRE, JMA, JIR, KQO
Dated: March 29, 2024
Received: March 29, 2024

Dear Dylan Wu:

We have reviewed your section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (the Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov

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K232317 – Dylan Wu
Page 2

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801 and Part 809); medical device reporting (reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reporting-combination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-devices/medical-device-safety/medical-device-reporting-mdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

Paula V. Caposino -
S

Paula Caposino, Ph.D.
Deputy Division Director
Division of Chemistry and Toxicology Devices
OHT7: Office of In Vitro Diagnostics
Office of Product Evaluation and Quality
Center for Devices and Radiological Health

Enclosure

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FORM FDA 3881 (6/20)
Page 1 of 1
PSC Publishing Services [phone]
EF

| DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Indications for Use | Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below. |
| --- | --- |
| 510(k) Number (if known) K232317 | |
| Device Name UC-1800 Automatic Urine Analyzer URIT 11FA Urine Reagent Strips URIT 12FA Urine Reagent Strips | |
| Indications for Use (Describe) The UC-1800 Automatic Urine Analyzer is automated instrument which is intended for professional, in vitro diagnostic use only. Depending on the reagent strips being used, the instruments perform semi-quantitative detection of the following analytes in urine: ascorbic acid, microalbumin, leukocytes, creatinine, ketone, urobilinogen, bilirubin, glucose, protein, specific gravity, blood and pH in urine and for qualitative determination of nitrite in urine. The urine hydrometer (optional) can determine the color and turbidity of urine. Test results may provide information regarding the status of carbohydrate metabolism, kidney and liver function, acid-base balance and bacteriuria. The URIT 11FA urine reagent strips provide semi-quantitative tests for ascorbic acid, leukocytes, ketone, urobilinogen, bilirubin, glucose, protein, specific gravity, blood and pH in urine and for qualitative determination of nitrite in urine. The URIT 11FA urine reagent strips are for use with the UC-1800 Automatic Urine Analyzer and are for professional, in vitro diagnostic use only. Test results may provide information regarding the status of carbohydrate metabolism, kidney and liver function, acid-base balance and bacteriuria. The URIT 12FA urine reagent strips provide semi-quantitative tests for microalbumin, leukocytes, creatinine, ketone, urobilinogen, bilirubin, glucose, protein, specific gravity, blood and pH in urine and for qualitative determination of nitrite in urine. The URIT 12FA urine reagent strips are for use with the UC-1800 Automatic Urine Analyzer and are for professional, in vitro diagnostic use only. Test results may provide information regarding the status of carbohydrate metabolism, kidney and liver function, acid-base balance and bacteriuria. | |
| Type of Use (Select one or both, as applicable) ☑ Prescription Use (Part 21 CFR 801 Subpart D) ☐ Over-The-Counter Use (21 CFR 801 Subpart C) | |
| CONTINUE ON A SEPARATE PAGE IF NEEDED. | |
| This section applies only to requirements of the Paperwork Reduction Act of 1995. *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* | |
| The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff [e-mail] "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." | |

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URIT MEDICAL ELECTRONIC CO., LTD.
No. D-07 Information Industry District, High-Tech Zone, Guilin, Guangxi 541004, P. R. China

# 510(K) Summary

# K232317

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirement by 21 CFR 807.92

Date prepared: 25th, April 2024

# 1 Submitter's Information

Name: URIT Medical Electronic Co., Ltd.

Address: No. D-07 Information Industry District, High-Tech Zone, Guilin, Guangxi 541004, P. R. China

Contact Person: Jun Jiang

Title: Manager

Tel: [phone]

FAX: [phone]

Email: [e-mail]

# 2 Official Contact Person Information

Primary contact: Mr. Dylan Wu

Shanghai SUNGO Management Consulting Co., Ltd.

Room 1401, Dongfang Building, 1500# Century Ave., Shanghai 200122, China

Tel: [phone]

Email: [e-mail]

Secondary contact: Mr. Raymond Luo

Room 1401, Dongfang Building, 1500# Century Ave., Shanghai 200122, China

Tel: [phone]

Email: [e-mail]

# 3 Subject Device

## 3.1 Trade Name and Regulatory Information:

| No. | Trade name | Regulatory Information |
| --- | --- | --- |
| 1 | UC-1800
Automatic Urine Analyzer | Class I §21 CFR 862.2900
Automated Urinalysis System |
| 3 | URIT 11FA Urine Reagent Strips | Class II (Blood and Glucose analytes raise system to Class II / 510(k) required) |
| 4 | URIT 12FA Urine Reagent Strips | Class II (Blood, Glucose and Creatinine analytes raise system to Class II / 510(k) required) |

## 3.2 Classification Information

| No. | Regulation 21 CFR Section | Product Code | Classification | Description | Panel |
| --- | --- | --- | --- | --- | --- |
| 1 | 862.2900 | KQO | Class I | Automated Urinalysis System | Clinical Chemistry |
| 2 | 862.1225 | JFY | Class II | Creatinine test System | Clinical Chemistry |
| 3 | 862.1645 | JIR | Class I | Protein or Albumin (Urinary, Non-Quant.) | Clinical Chemistry |

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URIT MEDICAL ELECTRONIC CO., LTD.

No. D-07 Information Industry District, High-Tech Zone, Guilin, Guangxi 541004, P. R. China

| No. | Regulation 21 CFR Section | Product Code | Classification | Description | Panel |
| --- | --- | --- | --- | --- | --- |
| 4 | 862.1340 | JIL | Class II | Glucose (Urinary, Non-Quantitative) | Clinical Chemistry |
| 5 | 864.6550 | JIO | Class II | Blood, Occult, Colorimetric, In Urine | Hematology |
| 6 | 862.1785 | CDM | Class I | Urobilinogen (Urinary Non-Quant.) | Clinical Chemistry |
| 7 | 862.1550 | CEN | Class I | pH (Urinary, Non-Quant.) | Clinical Chemistry |
| 8 | 862.1435 | JIN | Class I | Ketones (Urinary, Non-Quant.) | Clinical Chemistry |
| 9 | 862.1645 | JIR | Class I | Protein or Albumin (Urinary, Non-Quant.) | Clinical Chemistry |
| 10 | 862.1115 | JJB | Class I | Urinary Bilirubin & Its Conjugates (Urinary, Non-Quant.) | Clinical Chemistry |
| 11 | 862.1510 | JMT | Class I | Nitrite (Urinary, Non-Quant.) | Clinical Chemistry |
| 12 | 864.7675 | LJX | Class I | Leukocyte peroxidase test | Hematology |
| 13 | 862.2800 | JRE | Class I | Specific Gravity | Clinical Chemistry |
| 14 | 862.1095 | JMA | Class I | Ascorbic Acid Test System | Clinical Chemistry |

## 4 Predicate device

510(k) Number: K082811

Uritest 500B Urine Analyzer

Uritest 50 Urine Analyzer

Uritest 10G Urine Reagent Strips

Uritest 11G Urine Reagent Strips

510(k) Number: K142391

Mission® U120 Ultra Urine Analyzer

Mission® Urinalysis Reagent Strips (Microalbumin/Creatinine)

Mission® Liquid Urine Controls, Mission® Liquid Diptube Urine Controls

510(k) Number: K093098

AUTION MAX AX-4030 Urinalysis System

## 5 Device Description

### 5.1 UC-1800 Automatic Urine Analyzer

UC-1800 Automatic Urine Analyzer is characterized by fully automated and simple operation. All you need to do is to set test strips and samples, press the START key, and the rest of operations are fully automated with UC-1800, which can measure samples continuously. For each measurement, the instrument automatically performs a series of operation: sample transmitting, sample aspirating, sample dropping, rinsing, strip sorting, strip feeding and color identifying, etc. The instrument is used in conjunction with a serial of URIT urine test strips for measuring 15 parameters. Measure results are printed through either built-in printer or external printer. The test principle of the device is described as below.

#### a Test strip measurement principle

Measurement of test strips is done by the reflectance photometry method.

Placing tube racks loaded with samples on the rack injection mechanism and clicking the START key, the instrument will automatically perform a series of operations, such as transmitting samples, selecting strips, reading barcode, aspirating

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URIT MEDICAL ELECTRONIC CO., LTD.

No. D-07 Information Industry District, High-Tech Zone, Guilin, Guangxi 541004, P. R. China

samples, dropping samples, measuring samples and printing results, until all tube racks are done. During the measurement, the reacted pads on strip (calibration pad is not involved in reaction, just for reference) will change colors and absorb irradiated monochromatic light as a result of chemical reaction within 60 seconds. Then the optical mechanism will compare the reflective light amount of each reacted pad with the reflective light amount of the calibration pad. The concentrations of analyzes will be calculated by CPU and printed together with semi-quantitative symbols.

The measuring system consists of a light source (LED) and a light receptor. The light from the light source falls on the reacted pads and the calibration pad on the strip. The absorbent and reflective light amounts vary with the color of reagent pads. If the color is darker, more light is absorbed, and less light is reflected, vice versa. i.e., the degree of color development is proportional to the concentration of analyzes in urine. The reflectance is calculated using the following formula:

$$
R \% = \frac {T _ {m} \cdot C _ {s}}{T _ {s} \cdot C _ {m}} \times 100 \% \tag{1}
$$

R: Reflectance

Tm: Reflective light amount at the reactive pad with the measurement wavelength

Ts: Reflective light amount at the reactive pad with the reference wavelength

Cm: Reflective light amount at the calibration pad with the measurement wavelength

Cs: Reflective light amount at the calibration pad with the reference wavelength

The reflected lights from reagent pads are transmitted in the optical unit and received by the light receptor, where the optical signals are transformed into electrical signals. Then the electrical signals are transformed through I/V converter, processed by CPU and finally printed out.

## b Specific gravity measurement principle

Specific gravity measurement method is refractometer, which using the correlation between light refractive index and total solids in the solution to determine.

Refractometer method, available at $15^{\circ}\mathrm{C} \sim 38^{\circ}\mathrm{C}$ temperature range of use, before use can be calibrated by the temperature compensation device; available for use the known standard high specific gravity concentration solution and standard low specific gravity deionized water to calibrate; easy to standardization, less quantity of samples, especially suitable for patients with oliguria and pediatric patients. Refractometer method is recommended as reference method by Clinical Laboratory Standard Institution, CLSI and Chinese Committee for Clinical Laboratory Standards, CCCLS.

Specific gravity is based on the principle of different concentrations of urine sample which have different refractive indexes to measure, that is uses the same wavelength of monochromatic parallel light comes into the triple prism which contains urine sample, and then according to position of refracted ray in photoelectric technology detector (displacement sensor) to determine the specific gravity value. Specific gravity measurement principle functional block diagram is shown in Figure 1 below.

Figure 1 Specific gravity measurement principle

Specific gravity results are calculated by the following formulas:

$$
S G _ {X} = \left(S G _ {H} - S G _ {L}\right) \cdot \frac {K _ {X} - K _ {L}}{K _ {H} - K _ {L}} + S G _ {L} \tag {2}
$$

can change to

$$
\frac {S G _ {X} - S G _ {L}}{S G _ {H} - S G _ {L}} = \frac {K _ {X} - K _ {L}}{K _ {H} - K _ {L}} \tag {3}
$$

relationship between them is linear.

SG_H: The specific gravity of high concentration solution

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URIT MEDICAL ELECTRONIC CO., LTD.

No. D-07 Information Industry District, High-Tech Zone, Guilin, Guangxi 541004, P. R. China

$SG_{L}$ : The specific gravity of low concentration solution

$SG_{X}$ : The specific gravity of sample solution

$K_{H}$ : High concentration solution position coefficient

$K_{L}$ : Low concentration solution position coefficient

$K_{X}$ : Sample solution position coefficient

Position coefficient: It is calculated by the detector output data, and has a linear relationship with the refractive index.

Refractive index change depends on the temperature of the sample solution, and the specific gravity value is using the following formula to correct.

$$
S G _ {t} = S G _ {X} + \left(T _ {S A M} - T _ {S T D}\right) \cdot C _ {t} \tag {4}
$$

$SG_{t}$ : The specific gravity of high concentration solution

$SG_{X}$ : The specific gravity of low concentration solution

$T_{SAM}$ : The temperature of sample solution

$T_{STD}$ : The temperature of low concentration solution

$C_{t}$ : Temperature coefficient (SG 0.001/3°C) (temperature coefficient)

If the urine sample contains large amounts of glucose or protein, then the specific gravity will be affected, according to WS/T 229-229 "Physical, chemical and microscopic examination of urine" 5.4.1 requirements: 1 g/L protein will increase urine specific gravity 0.0003, 1 g/L glucose will increase urine specific gravity 0.0004. So, the specific gravity results will be corrected through the glucose and protein level which was measured by the test strip.

$$
S G = S G _ {t} - C _ {G L U} - C _ {P R O} \tag {5}
$$

SG: Specific gravity value which after the temperature compensation

$SG_{t}$ : Specific gravity value which gets from formula (4)

$C_{GLU}$ : Glucose correction value

$C_{PRO}$ : Protein correction value

## c Turbidity measurement principle

Turbidity module emits light, to make it go through the sample, and then detect how much light is scattered by the particles in the water from the direction at a 90-degree angle to the incident light (The most stable angle of scattered light, is at a right angle to the center line of the incident light, so measuring the scattered light from 90° direction which can minimize the influence of particle size on scattering light intensity). This scattered light measurement method called scattering method. Turbidity measurement principle functional block diagram is shown in Figure 2 below.

Figure 2 Turbidity measurement principle

Turbidity result is calculated by the following formula:

$$
T = \left(S _ {S} / T _ {S} - S _ {W} / T _ {W}\right) / K \tag {6}
$$

T: Turbidity level

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URIT MEDICAL ELECTRONIC CO., LTD.

No. D-07 Information Industry District, High-Tech Zone, Guilin, Guangxi 541004, P. R. China

$S_{S}$ : Sample scattered light level
$T_{S}$ : Sample transmission light level
$S_{w}$ : Flushing fluid scattered light level
$T_{w}$ : Flushing fluid transmission light level
K: Coefficient factor

# d Color measurement principle

The color of often seen objects, are actually the objects surfaces absorb a part of chromatic light from the white light(sunlight) that fall on them, and then reflect the other part of chromatic light to human eyes' response. Various frequencies of visible light are mixed together become white, that is to say, it contains all sorts of color of light, such as red(R), yellow(Y), green(G), blue(B), purple(P). According to the German physicist Helinholtz's three primary colors theory, all sorts of color is made of different proportion of three primary colors (red, green, blue).

Primary colors are the "basic color" which cannot be gotten by other colors mixed. But mix the primary colors in different proportion will get other new colors. Three primary colors of light are RGB (Red, Green, and Blue). Equivalent red light +green light=yellow light, green light +blue light = cyan light. Equivalent red light +blue light = magenta light, equivalent red +green+ blue=white, and if the intensity of these three lights is zero, it is black (dark).

When the white light through colored solution, the non-solution colors light will be absorbed, so the color of the light through the solution can be expressed as the color of the solution, and then the solution color can be detected by the professional color recognition sensor (filter) which in the back-end of the solution.

Figure 3 Principle of color detection

# 5.2 URIT 11FA/12FA urine reagent strips

Urine Reagent Strips is used to determine the components to be measured in urine by dry chemistry method together with urine analyzer. Various components to be tested in the urine can result in changes to the colors of corresponding reagent blocks on the Urine Reagent Strips. The depth of reaction color is proportional to the concentration of the corresponding component to be tested in the urine. Qualitative and semi-quantitative detection can be conducted to the contents of the corresponding detected components. As a reagent for the determination of multiple components in human urine and the most basic test item for clinical urine analysis (urine routine test), it is suitable for the screening test or auxiliary diagnosis for clinical diagnosis, without the specificity for diseases or indications, and urine dry chemistry test is only used as a screening test and cannot be used as a single diagnostic method.

# a Ascorbic Acid

Based on the principle of Tillman's Reagent, Ascorbic acid can reduce the dye from blue to red. The purpose of the determination of this project is to provide the user with the content of Ascorbic acid in the sample to determine its possible interference.

# b Nitrite

In this reaction, nitrate is reduced to nitrite by Gram-negative bacteria in the urine, the nitrite will react with arsanilic acid to form a diazonium compound, and the diazonium compound will be combined with naphthyl ethylenediamine dihydrochloride to show a pink color.

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URIT MEDICAL ELECTRONIC CO., LTD.
No. D-07 Information Industry District, High-Tech Zone, Guilin, Guangxi 541004, P. R. China

## c Microalbumin

Based on the dye-binding method, microalbumin can react with the dye to form a pink complex and generate produce a color change, which is particularly sensitive to the reaction of albumin.

## d Leukocytes

Based on the principle of esterase method, granulosa cytoplasm contains esterase which can hydrolyze a 3-hydroxyindoxyl ester substrate, release phenol and react with diazo reagent to generate purple-red compounds.

## e Creatinine

Based on the principle of displacement reaction, creatinine can displace the dye in the metal chloride-acid dye complex, and the color will change from green to yellow.

## f Ketone

Based on the principle of sodium nitro prussiate method, sodium nitroprusside can interact with ketone (acetoacetate) under alkaline conditions to become purple, especially acetoacetate is particularly sensitive to this.

## g Urobilinogen

Based on the principle of azo-binding method, urobilinogen is coupled with diazonium salt under strong acid conditions to form carmine pigment.

## h Bilirubin

Based on the principle of azo-coupling method, 2,4-dichloroaniline diazonium salt can react specifically with bilirubin, and produce different colors depending on the concentration of bilirubin.

## i Glucose

Based on the reaction principle of glucose oxidase method, glucose oxidase can specifically oxidize $\beta$-D-glucose to generate glucuronic acid and hydrogen peroxide that will oxidize the indicator under the action of peroxidase and show a purple-red color.

## j Protein

Based on the principle of protein error method of dye binding, the protein can combine with the dye to form a complex that produce a color change, especially the response to albumin is more sensitive than that of globulin, hemoglobin, Bence-Jone protein and mucin.

## k Blood

Based on the principle of hemoglobin contact activity method, the decomposition of peroxides can be catalyzed through the peroxidase-like action of hemoglobin, so that tetramethylbenzidine is oxidized and colored.

## l Specific Gravity

Using the polyelectrolyte method, and based on the principle of ion exchange between electrolytes in urine and polyelectrolytes. In the presence of cations, the polymer hydrogen ions will be released through exchange, and the color of bromothymol blue indicator will change from blue to blue-green and finally to yellow.

## m pH

The pH value within the range from 5.0 to 9.0 is measured by pH indicator, and the pH value of fresh urine of normal people is within the range from 5.5 to 7.0.

## 6 Indications for use/Intended use

The UC-1800 Automatic Urine Analyzer is automated instrument, which is intended for professional, in vitro diagnostic use only.

Depending on the reagent strips being used, the instruments perform semi-quantitative detection of the following analytes in urine: ascorbic acid, microalbumin, leukocytes, creatinine, ketone, urobilinogen, bilirubin, glucose, protein, specific gravity, blood and pH in urine and for qualitative determination of nitrite in urine. The urine hydrometer (optional) can determine the color and turbidity of urine. Test results may provide information regarding the status of carbohydrate

6 / 42

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URIT MEDICAL ELECTRONIC CO., LTD.

No. D-07 Information Industry District, High-Tech Zone, Guilin, Guangxi 541004, P. R. China

metabolism, kidney and liver function, acid-base balance and bacteriuria.

The URIT 11FA urine reagent strips provide semi-quantitative tests for ascorbic acid, leukocytes, ketone, urobilinogen, bilirubin, glucose, protein, specific gravity, blood and pH in urine and for qualitative determination of nitrite in urine. The URIT 11FA urine reagent strips are for use with the UC-1800 Automatic Urine Analyzer and are for professional, in vitro diagnostic use only. Test results may provide information regarding the status of carbohydrate metabolism, kidney and liver function, acid-base balance and bacteriuria.

The URIT 12FA urine reagent strips provide semi-quantitative tests for microalbumin, leukocytes, creatinine, ketone, urobilinogen, bilirubin, glucose, protein, specific gravity, blood and pH in urine and for qualitative determination of nitrite in urine. The URIT 12FA urine reagent strips are for use with the UC-1800 Automatic Urine Analyzer and are for professional, in vitro diagnostic use only. Test results may provide information regarding the status of carbohydrate metabolism, kidney and liver function, acid-base balance and bacteriuria.

# 7 Comparison of technological characteristics with the predicate device

Table 1 Technological characteristics of Proposed Device

| Feature | UC-1800 Automatic Urine Analyzer |
| --- | --- |
| Methodology | Reflectance photometer |
| Principle | Measurement of test strips is done by the reflectance photometry method, using CIS (contact image sensor) image scanning analysis technology to detect. |
| Chemistry | URIT 11FA Urine Reagent Strips URIT 12FA Urine Reagent Strips |
| Throughput | 480test/hour |
| Memory | 2 million sample data and 100,000 sample pictures. |
| PC Port | PS/2 interface, serial port, Ethernet interface, USB interface |
| Capabilities | Barcode Scanner; Built-in thermal printer or external USB printer |
| Available Languages on Screen | Chinese or English |
| Environment requirement | 15°C-30°C,RH ≤ 80% |
| Specimen ID enter | Manually enter or by bar code reader |
| Dimensions (L × W × H) | 653mm×641mm×570mm |
| Power Source | AC 100V-240V~, 50/60Hz, three-core power supply, good grounding. |
| Weight | 75kg |
| Calibration | The user can use the URIT urine control materials and calibration test strips to calibrate the instrument |

# 7.1 Substantial Equivalence

The URIT 11FA/12FA Urine Reagent Strips and the URIT UC-1800 Automatic Urine Analyzer is substantially equivalent to the Uritest 11G Urine Reagent Strips and the Uritest-500B Urine Analyzer (K082811) except Microalbumin and Creatinine. And the URIT 12FA Urine Reagent Strips and the URIT UC-1800 Automatic Urine Analyzer is substantially equivalent to the Mission® Urinalysis Reagent Strips (Microalbumin/Creatinine) and the Mission® U120 Ultra Urine Analyzer(K142391) Microalbumin and Creatinine only

And the URIT UC-1800 Automatic Urine Analyzer is substantially equivalent to AUTION MAX AX-4030 Urinalysis System (K093098) in detecting Specific Gravity, Turbidity and Color detected by Physical Module.

{10}

URIT MEDICAL ELECTRONIC CO., LTD.

No. D-07 Information Industry District, High-Tech Zone, Guilin, Guangxi 541004, P. R. China

Table 2 Total review of proposed device and predicate devices

| Device Name | Predicate Device Name | Predicate 510(K) number | Note |
| --- | --- | --- | --- |
| URIT UC-1800 Automatic Urine Analyzer | Uritest-500B Urine Analyzers | K082811 | Except Microalbumin/Creatinine |
| | Mission® U120 Ultra Urine Analyzer | K142391 | Microalbumin/Creatinine only |
| | AUTION MAX AX-4030 Urinalysis System | K093098 | Specific Gravity, Turbidity and Color detected by Physical Module |
| URIT 11FA Urine Reagent Strips | Uritest 11G Urine Reagent Strips | K082811 | N/A |
| URIT 12FA Urine Reagent Strips | Uritest 11G Urine Reagent Strips | K082811 | Except Microalbumin/Creatinine |
| URIT 12FA Urine Reagent Strips | Mission® Urinalysis Reagent Strips (Microalbumin/Creatinine) | K142391 | Microalbumin/Creatinine only |

{11}

URIT MEDICAL ELECTRONIC CO., LTD.

No. D-07 Information Industry District, High-Tech Zone, Guilin, Guangxi 541004, P. R. China

Table 3 Comparison with Predicate Devices (1)

| Device | Proposed Device (K232317) | Predicate Device 1(K082811) | Predicate Device 2(K142391) | Predicate Device 3 (K093098) |
| --- | --- | --- | --- | --- |
| Manufacturer | URIT Medical Electronic Co., Ltd. | URIT Medical Electronic Co., Ltd. | Acon Laboratories, Inc. | ARKRAY, Inc. |
| Device name | URIT UC-1800 Automatic Urine Analyzer | Uritest-500B Urine Analyzers | Mission® U120 Ultra Urine Analyzer | AUTION MAX AX-4030 Urinalysis System |
| Similarities | | | | |
| Classification | Class II (Blood, Glucose and Creatinine analytes raise system to Class II / 510(k) required) | Class II (Blood and Glucose analytes raise system to Class II / 510(k) required) | Class II (Creatinine analytes raise system to Class II / 510(k) required) | Class II (Blood and Glucose analytes raise system to Class II / 510(k) required) |
| Intended Use | UC-1800 Automatic Urine Analyzer is automated instruments which are intended for professional, in vitro diagnostic use only.Depending on the reagent strips being used, the instruments perform semi-quantitative detection of the following analytes in urine: ascorbic acid, microalbumin, leukocytes, creatinine, ketone, urobilinogen, bilirubin, glucose, protein, specific gravity, blood and pH in urine and for qualitative determination of nitrite in urine. The urine hydrometer (optional) can determine the specific gravity, color and turbidity of urine. Test results may provide reference for clinical examination and diagnosis. | Uritest-500B urine analyzer is semi-automated, bench top instruments which are intended for prescription, in vitro diagnostic use only. The instruments perform semi-quantitative detection of the following analytes in urine: leukocytes, ketone, nitrite, urobilinogen, bilirubin, protein, glucose, specific gravity, blood, pH and ascorbic acid. Test results may provide information regarding the status of carbohydrate metabolism, kidney and liver function, acid base balance and bacteriuria. The instruments use the accompanying check strip for daily calibration. | The Mission U120 Ultra Urine Analyzer is a urinalysis instrument intended for in vitro diagnostic use. It is intended for professional use only at point-of-care locations. The Mission U120 Ultra Urine Analyzer is intended to read Mission Urinalysis Reagent strips (Microalbumin/Creatinine) for the semi quantitative measurement of Albumin and Creatinine. These measurements are used to assist diagnosis for kidney function. | The AX-4030 is an automated urine analyzer that is designed to measure and analyze urine samples using measurements that include but are not limited to; Normal, STAT, Control and Check. These measurements are used to examine the following analytes; glucose (GLU), protein (PRO), bilirubin (BIL), urobilinogen (URO), pH (PH), blood (BLD), ketones (KET), nitrite (NIT) leukocytes (LEU) and specific gravity (S.G.). In addition, this device is used only with AUTION Sticks 9EB multi-parameter test strips. |
| Data Type | Qualitative, Semi-Quantitative | Qualitative, Semi-Quantitative | Semi-Quantitative | Semi-Quantitative |
| Location | Clinical Laboratory | Clinical Laboratory | Clinical Laboratory | Clinical Laboratory |
| Medical Device /IVD | Medical Device /IVD | Medical Device /IVD | Medical Device /IVD | Medical Device /IVD |
| Indications | For prescription use only. | For prescription use only. | For prescription use only. | For prescription use only. |
| Specimen Type | Human Urine | Human Urine | Human Urine | Human Urine |
| Analyte | With strips: Glucose, Blood, Urobilinogen, pH, Ketones, Protein, Bilirubin, Nitrite, Leukocyte, Specific Gravity, Ascorbic acid | Glucose, Blood, Urobilinogen, pH, Ketones, Protein, Bilirubin, Nitrite, Leukocyte, Specific Gravity, Ascorbic acid | N/A | N/A |
| | With strips: Creatinine, Microalbumin | N/A | Creatinine, Microalbumin | N/A |
| | With Physical module: Specific Gravity, Turbidity and Color | N/A | N/A | Specific Gravity, Turbidity and Color |
| Methodology/Principle | Test strips: Reflectance photometer, Measurement of test strips is done by the reflectance photometry method. using CIS (contact image sensor) image scanning analysis technology to detect.Specific Gravity: Refractometer methodColor: Light-transmission measurementTurbidity: Light-scattering measurement method | Reflectance photometer (Only Test strips)Ingredients that change color in reaction with analytes | Reflectance photometer (Only Test strips)The Mission® U120 Ultra Urine Analyzer utilizes a CMOS image sensor to measure the intensity of light. The frequency of the light is determined by the LED light source. | (without Test Strips)Specific gravity: Reflection refractometryColor hue: Light-transmission measurementTurbidity: Light-scattering measurement method |
| Specimen ID enter | Manually enter or by bar code reader | Manually enter or by bar code reader | Manually enter or by bar code reader | Barcode Reader |
| Environment requirement | 15°C-30°C,RH ≤ 80% | 15°C-30°C,RH ≤ 80% | 15-30°C (59-86°F); 20-80% Relative Humidity (noncondensing) | Temperature: 10-30°C,Humidity: 20-80% RH(No condensation) |

{12}

URIT MEDICAL ELECTRONIC CO., LTD.

No. D-07 Information Industry District, High-Tech Zone, Guilin, Guangxi 541004, P. R. China

Table 4 Comparison with Predicate Devices (2)

| Device | Proposed Device (K232317) | Predicate Device 1(K082811) | Predicate Device 2(K142391) | Predicate Device 3(K142392) |
| --- | --- | --- | --- | --- |
| Manufacturer | URIT Medical Electronic Co., Ltd. | URIT Medical Electronic Co., Ltd. | Acon Laboratories, Inc. | ARKRAY, Inc. |
| Device name | URIT UC-1800 Automatic Urine Analyzer | Uritest-500B Urine Analyzers | Mission® U120 Ultra Urine Analyzer | AUTION MAX AX-4030 Urinalysis System |
| Differences | | | | |
| Chemistry | URIT 11FA Urine Reagent Strips
URIT 12FA Urine Reagent Strips | Uritest 11G Urine Reagent Strips | Mission® Urinalysis Reagent Strips (Microlbumin/ Creatinine) | None |
| Available Languages on Screen | Chinese or English | Chinese or English | English and Spanish | English |
| Dimensions (L × W × H) | 653mm×641mm×570mm | 390 mm × 340 mm ×290 mm | 26.0 (L) x 15.0 (W) x 17.5 (H) cm | 530 (w) x 530(d) x 530 (h)(mm) |
| Power Source | AC 100V-240V~, 50/60Hz, three-core power supply, good grounding. | AC100-240V, 50/60Hz Input: 61VA | 100-240 VAC (adapter), (50-60Hz±1HZ)6 AA batteries with 100 tests/6 new batteries; | 100-240 VAC, 50/60 Hz |
| Weight | 75kg | 6.5 Kg | ≤1.66 kg (3.65 lbs.) without batteries or power supply | 41Kg (including the Sampler unit 4kg) |
| PC Port | PS/2 interface, serial port, Ethernet interface, USB interface | RS 232 port. | Standard RS232C Port (cable not included), USB Port (cable not included); (Not connect to PC) Bluetooth Wireless | RS-232C/ Ethernet |
| Capabilities | Barcode Scanner
Built-in thermal printer or external USB printer | Internal or external Printer | Internal thermal printer
Barcode reader Connector
External printer (optional)
Barcode reader (optional)
RJ45 Ethernet; (optional) | Built-in printer |
| Calibration | The user can use the URIT urine control materials and calibration test strips to calibrate the instrument | Self-calibration—white calibration bar | The Mission® U120 Ultra Urine Analyzer performs an automatic calibration each time a test is run. | N/A |
| Throughput | 400test/hour | 500 tests/hour | Single Test Mode: 55 tests/hour.
Continuous Test Mode: 120 tests/hour. | 225 samples/hour |
| Memory | 2 million sample data and 100,000 sample pictures. | 1,000 results | Last 2000 test results | 2500 tests |

{13}

URIT MEDICAL ELECTRONIC CO., LTD.

No. D-07 Information Industry District, High-Tech Zone, Guilin, Guangxi 541004, P. R. China

Characteristic of the URIT 11FA/12FA Urine Reagent Strips are compared with the Uritest 11G Urine Reagent Strips (K082811) for instrument reading in Table 5 to Table 7

Table 5 Comparison with Predicate Devices-Reagent strips (1)

| Device | Proposed Device | Predicate Device 1 |
| --- | --- | --- |
| Manufacturer | URIT Medical Electronic Co., Ltd. | URIT Medical Electronic Co., Ltd. |
| 510K number | K232317 | K082811 |
| Device name | URIT 11FA Urine Reagent Strips
URIT 12FA Urine Reagent Strips | Uritest 11G Urine Reagent Strips |
| Classification | Class II (Blood, Glucose and Creatinine analytes raise system to Class II / 510(k) required) | Class II (Blood and Glucose analytes raise system to Class II / 510(k) required) |
| Intended Use | The URIT 11FA urine reagent strips provide semi-quantitative tests for ascorbic acid, leukocytes, ketone, urobilinogen, bilirubin, glucose, protein, specific gravity, blood and pH in urine and for qualitative determination of nitrite in urine. The URIT 11FA urine reagent strips are for use with the UC-1800 Automatic Urine Analyzer and are for professional, in vitro diagnostic use only. The URIT 12FA urine reagent strips provide semi-quantitative tests for microalbumin, leukocytes, creatinine, ketone, urobilinogen, bilirubin, glucose, protein, specific gravity, blood and pH in urine and for qualitative determination of nitrite in urine. The URIT 12FA urine reagent strips are for use with the UC-1800 Automatic Urine Analyzer and are for professional, in vitro diagnostic use only. | Uritest 11G urine reagent strips provide semi-quantitative tests for Ascorbic acid, Nitrite, Leukocyte, Ketone, Urobilinogen, Bilirubin, Glucose, Protein, Blood, Specific Gravity, PH in urine. The Uritest 11 G urine reagent strips are for use with Uritest-500B urine analyzer and are for prescription, in vitro diagnostic use only. Test results may provide information regarding the status of carbohydrate metabolism, kidney and liver function, acid-base balance and bacteriuria
The strips are read instrumentally by the Uritest-500B Urine Analyzers |
| Indications | Professional in vitro diagnostic use | Same |
| Analytes | URIT 11FA/12FA Urine Reagent Strips: Nitrite, Leukocyte, Ketone, Urobilinogen, Bilirubin, Glucose, Protein, Blood, Specific Gravity, PH
URIT 11FA Urine Reagent Strips also provide the detection of Ascorbic acid, While URIT 12FA Urine Reagent Strips provide the detection of microalbumin and creatinine (Predicated with K142391) | Ascorbic acid, Nitrite, Leukocyte, Ketone, Urobilinogen, Bilirubin, Glucose, Protein, Blood, Specific Gravity, PH |
| Specimen | Human Urine | Same |
| Architecture | Firm plastic, dry reagent strips | Same |
| Storage | Store at 2°C-30°C | Same |

{14}

URIT MEDICAL ELECTRONIC CO., LTD.

No. D-07 Information Industry District, High-Tech Zone, Guilin, Guangxi 541004, P. R. China

Table 6 Comparison with Predicate Devices-Reagent strips (2)

| Device | Proposed Device | Predicate Device 1 |
| --- | --- | --- |
| Manufacturer | URIT Medical Electronic Co., Ltd. | URIT Medical Electronic Co., Ltd. |
| 510K number | K232317 | K082811 |
| Device name | URIT 11FA Urine Reagent StripsURIT 12FA Urine Reagent Strips | Uritest 11G Urine Reagent Strips |
| Classification | Class II (Blood, Glucose and Creatinine analytes raise system to Class II / 510(k) required) | Class II (Blood and Glucose analytes raise system to Class II / 510(k) required) |
| Test Principle | Ingredients that change color in reaction with analytes | Same |
| Blank block (calibrator) | The distribution of urine on the test block and the color of the urine itself will generally cause errors to the measurement results. The purpose of setting the blank block is to eliminate these factors that may cause error, and the same blank block is used for each project. | Same |
| Ascorbic acid | Based on the principle of Tillman's Reagent, Ascorbic acid can reduce the dye from blue to red. The purpose of the determination of this project is to provide the user with the content of Ascorbic acid in the sample to determine its possible interference. | Same |
| Nitrite | In this reaction, nitrate is reduced to nitrite by Gram-negative bacteria in the urine, the nitrite will react with arsanilic acid to form a diazonium compound, and the diazonium compound will be combined with naphthylethylenediamine dihydrochloride to show a pink color. | Same |
| Microalbumin | Based on the dye-binding method, microalbumin can react with the dye to form a pink complex and generate produce a color change, which is particularly sensitive to the reaction of albumin. | None |
| Leukocyte | Based on the principle of esterase method, granulosa cytoplasm contains esterase which can hydrolyze a 3-hydroxyindoxyl ester substrate, release phenol and react with diazo reagent to generate purple-red compounds. | Same |
| Creatinine | Based on the principle of displacement reaction, creatinine can displace the dye in the metal chloride-acid dye complex, and the color will change from green to yellow | None |
| Ketone | Based on the principle of sodium nitro prussiate method, sodium nitroprusside can interact with ketone (acetoacetate) under alkaline conditions to become purple, especially acetoacetate is particularly sensitive to this. | Same |
| Urobilinogen | Based on the principle of azo-binding method, urobilinogen is coupled with diazonium salt under strong acid conditions to form carmine pigment. | Same |
| Bilirubin | Based on the principle of azo-coupling method,2,4-dichloroaniline diazonium salt can react specifically with bilirubin, and produce different colors depending on the concentration of bilirubin. | Same |
| Glucose | Based on the reaction principle of glucose oxidase method, glucose oxidase can specifically oxidize β-D-glucose to generate glucuronic acid and hydrogen peroxide that will oxidize the indicator under the action of peroxidase and show a purple-red color. | Same |
| Protein | Based on the principle of protein error method of dye binding, the protein can combine with the dye to form a complex that produce a color change, especially the response to albumin is more sensitive than that of globulin, hemoglobin, Bence-Jone protein and mucin. | Same |
| Blood | Based on the principle of hemoglobin contact activity method, the decomposition of peroxides can be catalyzed through the peroxidase-like action of hemoglobin, so that tetramethylbenzidine is oxidized and colored. | Same |
| Specific Gravity | This test contains a detergent and Bromthymol blue that indicates the presence of ionic constituents in the urine by changing color from green to yellow. | Same |
| PH | The pH value within the range from 5.0 to 9.0 is measured by pH indicator, and the pH value of fresh urine of normal people is within the range from 5.5 to 7.0. | Same |
| Detection Range | Ascorbic Acid (10-100) mg/dL | Same |
| | Nitrite (+/-) | Same |
| | Leukocytes (15-500)leu/mcL | Same |
| | Ketone (5-80) mg/dL | Same |
| | Urobilinogen (2-8)EU/dL | Same |
| | Bilirubin (0.5-6.0) mg/dL | Same |
| | Glucose (50-1000) mg/dL | Same |
| | Protein(15-300)mg/dL | Same |
| | Blood (10-200) ery/mcL | Same |
| | Specific Gravity 1.005-1.030 | Same |
| | pH 5.0-9.0 | Same |

{15}

URIT MEDICAL ELECTRONIC CO., LTD.

No. D-07 Information Industry District, High-Tech Zone, Guilin, Guangxi 541004, P. R. China

Characteristic of the URIT 12FA Urine Reagent Strips in detecting Microalbumin and creatinine are compared with the Mission® Urinalysis Reagent Strips (Microalbumin/Creatinine) (K142391) read by Mission® U120 Ultra Urine Analyzer in Table 7.

Table 7 Comparison with Predicate Devices-Reagent strips (3)

| Device | Proposed Device | Predicate Device 2 |
| --- | --- | --- |
| Manufacturer | URIT Medical Electronic Co., Ltd. | Acon Laboratories, Inc. |
| 510K number | K232317 | K142391 |
| Device name | URIT 12FA Urine Reagent Strips (Only Microalbumin/Creatinine) | Mission® Urinalysis Reagent Strips (Microalbumin/Creatinine) |
| Classification | Class II | Class II |
| Similarities | | |
| Intended Use | The URIT 12FA urine reagent strips provide semi-quantitative tests for microalbumin, leukocytes, creatinine, ketone, urobilinogen, bilirubin, glucose, protein, specific gravity, blood and pH in urine and for qualitative determination of nitrite in urine. The URIT 12FA urine reagent strips are for use with the UC-1800 Automatic Urine Analyzer and are for professional, in vitro diagnostic use only. | The Mission Urinalysis Reagent strips (Microalbumin/Creatinine) are intended for the semi quantitative measurement of albumin and creatinine in urine samples using the Mission U120 Ultra Urine Analyzer. These measurements are used to assist diagnosis for kidney function. It is intended for professional use only at point-of-care locations. The strips are read instrumentally by the Mission® U120 Ultra Urine Analyzer |
| Indications | Professional in vitro diagnostic use | Professional use in point-of-care urine testing |
| Analytes | Microalbumin and Creatinine | Microalbumin and creatinine |
| Specimen | Human Urine | Human Urine |
| Architecture | Firm plastic, dry reagent strips | Plastic strips affixed with two separate reagent areas. |
| Differences | | |
| Test Principle | Ingredients that change color in reaction with analytes | Intensity of the light reflected from the reagent areas of a urinalysis reagent strip. |
| Storage | Store at 2°C-30°C | Store at 15°C-30°C |
| Microalbumin Detection Methodology | Based on the dye-binding method, microalbumin can react with the dye to form a pink complex and generate produce a color change, which is particularly sensitive to the reaction of albumin. | This test is based on dye binding using a high affinity sulfone phthalein dye. At a constant pH, the development of any blue color is due to the presence of albumin. The resulting color ranges from pale green to aqua blue |
| Creatinine Detection Methodology | Based on the principle of displacement reaction, creatinine can displace the dye in the metal chloride-acid dye complex, and the color will change from green to yellow. | This test is based on the peroxidase-like activity of a copper creatinine complex that catalyzes the reaction of diisopropylbenzene dihydroperoxide and 3,3',5,5'- tetramethylbenzidine. The resulting color ranges from orange through green to blue |
| Detection Range | Microalbumin (10-150) mg/L | Detects albumin between 10-150mg/L |
| | Creatinine(10-300)mg/dL | Detects creatinine between 10-300 mg/dL (0.9 - 26.5 mmol/L) |

Therefore, it can be concluded that the subject device and the proposed device are substantially equivalent.

{16}

URIT MEDICAL ELECTRONIC CO., LTD.

No. D-07 Information Industry District, High-Tech Zone, Guilin, Guangxi 541004, P. R. China

# 8 Summary of Non-Clinical Testing

# 8.1 Analytical performance

# a Precision /Reproducibility

The Repeatability (With-in Run) Precision of the URIT UC-1800 Automatic Urine Analyzer was evaluated by using negative urines and spiked urines of known concentrations for each analyte. Each sample was tested in 20 replicates across 3 instruments with the 3lots of URIT 11FA Urine Reagent Strips and 3lots of URIT 12FA Urine Reagent Strips in each instrument for a total of 60 measurements at each concentration. All concentrations for all tests had 60 of 60 (100%) match at $\pm$ one color block. The results are summarized in Table 8 to Table 11.

Table 8 Summary of Repeatability (With-in Run) Precision of URIT 11FA Urine Reagent Strips

| Test | Expected Value | | | | | |
| --- | --- | --- | --- | --- | --- | --- |
| Ascorbic acid (mg/dL) | -(0) | +-(10) | +1(25) | +2(50) | +3(100) | |
| Exact agreement | 100% (60/60) | 100% (60/60) | 100% (60/60) | 100% (60/60) | 100% (60/60) | |
| ± 1 color block | 100% (60/60) | 100% (60/60) | 100% (60/60) | 100% (60/60) | 100% (60/60) | |
| Conclusion | Qualified | Qualified | Qualified | Qualified | Qualified | |
| Nitrite | -(Negative) | +(Positive) | | | | |
| Exact agreement | 100% (60/60) | 100% (60/60) | | | | |
| ± 1 color block | 100% (60/60) | 100% (60/60) | | | | |
| Conclusion | Qualified | Qualified | | | | |
| Leukocyte(leu/μL) | -(0) | +-(15) | +1(70) | +2(125) | +3(500) | |
| Exact agreement | 100% (60/60) | 100% (60/60) | 100% (60/60) | 100% (60/60) | 100% (60/60) | |
| ± 1 color block | 100% (60/60) | 100% (60/60) | 100% (60/60) | 100% (60/60) | 100% (60/60) | |
| Conclusion | Qualified | Qualified | Qualified | Qualified | Qualified | |
| Ketone (mg/dL) | -(0) | +-(5) | +1(15) | +2(40) | +3(80) | |
| Exact agreement | 100% (60/60) | 100% (60/60) | 100% (60/60) | 100% (60/60) | 100% (60/60) | |
| ± 1 color block | 100% (60/60) | 100% (60/60) | 100% (60/60) | 100% (60/60) | 100% (60/60) | |
| Conclusion | Qualified | Qualified | Qualified | Qualified | Qualified | |
| Urobilinogen (EU/dL) | Normal | | +1(2.0) | +2(4.0) | +3(8.0) | |
| Exact agreement | 100% (60/60) | | 100% (60/60) | 96.7% (58/60) | 100% (60/60) | |
| ± 1 color block | 100% (60/60) | | 100% (60/60) | 100% (60/60) | 100% (60/60) | |
| Conclusion | Qualified | | Qualified | Qualified | Qualified | |
| Bilirubin (mg/dL) | -(0) | | +1(0.5) | +2(2.0) | +3(6.0) | |
| Exact agreement | 100% (60/60) | | 100% (60/60) | 96.7% (58/60) | 100% (60/60) | |
| ± 1 color block | 100% (60/60) | | 100% (60/60) | 100% (60/60) | 100% (60/60) | |
| Conclusion | Qualified | | Qualified | Qualified | Qualified | |
| Glucose(mg/dL) | -(0) | +-(50) | +1(100) | +2(250) | +3(500) | +4(1000) |
| Exact agreement | 100% (60/60) | 100% (60/60) | 100% (60/60) | 100% (60/60) | 100% (60/60) | 100% (60/60) |
| ± 1 color block | 100% (60/60) | 100% (60/60) | 100% (60/60) | 100% (60/60) | 100% (60/60) | 100% (60/60) |
| Conclusion | Qualified | Qualified | Qualified | Qualified | Qualified | |
| Protein(mg/dL) | -(0) | +-(15) | +1(30) | +2(100) | +3(300) | |
| Exact agreement | 100% (60/60) | 100% (60/60) | 93.3% (56/60) | 100% (60/60) | 100% (60/60) | |
| ± 1 color block | 100% (60/60) | 100% (60/60) | 100% (60/60) | 100% (60/60) | 100% (60/60) | |
| Conclusion | Qualified | Qualified | Qualified | Qualified | Qualified | |
| Specific Gravity | 1.005 | 1.010 | 1.015 | 1.020 | 1.025 | 1.030 |
| Exact agreement | 100% (60/60) | 96.7% (58/60) | 100% (60/60) | 100% (60/60) | 100% (60/60) | 100% (60/60) |
| ± 1 color block | 100% (60/60) | 100% (60/60) | 100% (60/60) | 100% (60/60) | 100% (60/60) | 100% (60/60) |

{17}

URIT MEDICAL ELECTRONIC CO., LTD.

No. D-07 Information Industry District, High-Tech Zone, Guilin, Guangxi 541004, P. R. China

| Test | Expected Value | | | | | |
| --- | --- | --- | --- | --- | --- | --- |
| Blood(CELL/μL) | -(0) | +-(10) | +1(25) | +2(80) | +3(200) | |
| Exact agreement | 100% (60/60) | 100% (60/60) | 98.3% (59/60) | 100% (60/60) | 100% (60/60) | |
| ± 1 color block | 100% (60/60) | 100% (60/60) | 100% (60/60) | 100% (60/60) | 100% (60/60) | |
| Conclusion | Qualified | Qualified | Qualified | Qualified | Qualified | |
| pH | 5.0 | 5.5 | 6.0 | 6.5 | 7.0 | 7.5 |
| Exact agreement | 100% (60/60) | 100% (60/60) | 100% (60/60) | 100% (60/60) | 96.7% (58/60) | 100% (60/60) |
| ± 1 color block | 100% (60/60) | 100% (60/60) | 100% (60/60) | 100% (60/60) | 100% (60/60) | 100% (60/60) |
| Conclusion | Qualified | Qualified | Qualified | Qualified | Qualified | |
| pH | 8.0 | 8.5 | 9.0 | | | |
| Exact agreement | 100% (60/60) | 100% (60/60) | 100% (60/60) | | | |
| ± 1 color block | 100% (60/60) | 100% (60/60) | 100% (60/60) | | | |
| Conclusion | Qualified | Qualified | Qualified | | | |

Table 9 Summary of Repeatability (With-in Run) Precision of URIT 12FA Urine Reagent Strips

| Test | Expected Value | | | | | |
| --- | --- | --- | --- | --- | --- | --- |
| Nitrite | -(Negative) | +(Positive) | | | | |
| Exact agreement | 100% (60/60) | 100% (60/60) | | | | |
| ± 1 color block | 100% (60/60) | 100% (60/60) | | | | |
| Conclusion | Qualified | Qualified | | | | |
| Leukocyte(leu/μL) | -(0) | +-(15) | +1(70) | +2(125) | +3(500) | |
| Exact agreement | 100% (60/60) | 100% (60/60) | 100% (60/60) | 100% (60/60) | 100% (60/60) | |
| ± 1 color block | 100% (60/60) | 100% (60/60) | 100% (60/60) | 100% (60/60) | 100% (60/60) | |
| Conclusion | Qualified | Qualified | Qualified | Qualified | Qualified | |
| Ketone (mg/dL) | -(0) | +-(5) | +1(15) | +2(40) | +3(80) | |
| Exact agreement | 100% (60/60) | 100% (60/60) | 96.7% (58/60) | 96.7% (58/60) | 100% (60/60) | |
| ± 1 color block | 100% (60/60) | 100% (60/60) | 100% (60/60) | 100% (60/60) | 100% (60/60) | |
| Conclusion | Qualified | Qualified | Qualified | Qualified | Qualified | |
| Urobilinogen (EU/dL) | Normal | | +1(2.0) | +2(4.0) | +3(8.0) | |
| Exact agreement | 100% (60/60) | | 100% (60/60) | 100% (60/60) | 100% (60/60) | |
| ± 1 color block | 100% (60/60) | | 100% (60/60) | 100% (60/60) | 100% (60/60) | |
| Conclusion | Qualified | | Qualified | Qualified | Qualified | |
| Bilirubin (mg/dL) | -(0) | | +1(0.5) | +2(2.0) | +3(6.0) | |
| Exact agreement | 100% (60/60) | | 98.3% (59/60) | 91.7% (55/60) | 100% (60/60) | |
| ± 1 color block | 100% (60/60) | | 100% (60/60) | 100% (60/60) | 100% (60/60) | |
| Conclusion | Qualified | | Qualified | Qualified | Qualified | |
| Glucose(mg/dL) | -(0) | +-(50) | +1(100) | +2(250) | +3(500) | +4(1000) |
| Exact agreement | 100% (60/60) | 100% (60/60) | 100% (60/60) | 100% (60/60) | 100% (60/60) | 100% (60/60) |
| ± 1 color block | 100% (60/60) | 100% (60/60) | 100% (60/60) | 100% (60/60) | 100% (60/60) | 100% (60/60) |
| Conclusion | Qualified | Qualified | Qualified | Qualified | Qualified | |
| Protein(mg/dL) | -(0) | +-(15) | +1(30) | +2(100) | +3(300) | |
| Exact agreement | 100% (60/60) | 100% (60/60) | 93.3% (56/60) | 100% (60/60) | 100% (60/60) | |
| ± 1 color block | 100% (60/60) | 100% (60/60) | 100% (60/60) | 100% (60/60) | 100% (60/60) | |
| Conclusion | Qualified | Qualified | Qualified | Qualified | Qualified | |
| Specific Gravity | 1.005 | 1.010 | 1.015 | 1.020 | 1.025 | 1.030 |
| Exact agreement | 100% (60/60) | 100% (60/60) | 100% (60/60) | 100% (60/60) | 100% (60/60) | 100% (60/60) |
| ± 1 color block | 100% (60/60) | 100% (60/60) | 100% (60/60) | 100% (60/60) | 100% (60/60) | 100% (60/60) |

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URIT MEDICAL ELECTRONIC CO., LTD.

No. D-07 Information Industry District, High-Tech Zone, Guilin, Guangxi 541004, P. R. China

| Test | Expected Value | | | | | |
| --- | --- | --- | --- | --- | --- | --- |
| Conclusion | Qualified | Qualified | Qualified | Qualified | Qualified | Qualified |
| Blood(CELL/μL) | -(0) | +-(10) | +1(25) | +2(80) | +3(200) | |
| Exact agreement | 100% (60/60) | 100% (60/60) | 100% (60/60) | 100% (60/60) | 100% (60/60) | |
| ± 1 color block | 100% (60/60) | 100% (60/60) | 100% (60/60) | 100% (60/60) | 100% (60/60) | |
| Conclusion | Qualified | Qualified | Qualified | Qualified | Qualified | |
| pH | 5.0 | 5.5 | 6.0 | 6.5 | 7.0 | 7.5 |
| Exact agreement | 100% (60/60) | 100% (60/60) | 100% (60/60) | 100% (60/60) | 100% (60/60) | 100% (60/60) |
| ± 1 color block | 100% (60/60) | 100% (60/60) | 100% (60/60) | 100% (60/60) | 100% (60/60) | 100% (60/60) |
| Conclusion | Qualified | Qualified | Qualified | Qualified | Qualified | Qualified |
| pH | 8.0 | 8.5 | 9.0 | | | |
| Exact agreement | 100% (60/60) | 100% (60/60) | 100% (60/60) | | | |
| ± 1 color block | 100% (60/60) | 100% (60/60) | 100% (60/60) | | | |
| Conclusion | Qualified | Qualified | Qualified | | | |
| Microalbumin | 10mg/L | 30mg/L | 80mg/L | 150mg/L | | |
| Exact agreement | 100% (60/60) | 100% (60/60) | 100% (60/60) | 100% (60/60) | | |
| ± 1 color block | 100% (60/60) | 100% (60/60) | 100% (60/60) | 100% (60/60) | | |
| Conclusion | Qualified | Qualified | Qualified | Qualified | | |
| Creatinine | 10 mg/dL | 50 mg/dL | 100 mg/dL | 200 mg/dL | 300 mg/dL | |
| Exact agreement | 100% (60/60) | 100% (60/60) | 100% (60/60) | 100% (60/60) | 100% (60/60) | |
| ± 1 color block | 100% (60/60) | 100% (60/60) | 100% (60/60) | 100% (60/60) | 100% (60/60) | |
| Conclusion | Qualified | Qualified | Qualified | Qualified | Qualified | |

Table 10 Summary of Repeatability (With-in Run) Precision of Physical Module Item Turbidity

| Test | Expected Value | | | |
| --- | --- | --- | --- | --- |
| Turbidity | Clear | Micro turbid | Turbid | Very turbid |
| Exact agreement | 100% (60/60) | 100% (60/60) | 100% (60/60) | 100% (60/60) |
| ± 1 Block | 100% (60/60) | 100% (60/60) | 100% (60/60) | 100% (60/60) |
| Conclusion | Qualified | Qualified | Qualified | Qualified |

Table 11 Summary of Repeatability (With-in Run) Precision of Physical Module Item Color

| Test | Color | Exact agreement | Conclusion |
| --- | --- | --- | --- |
| Expected Value | Colorless | 100% (60/60) | Qualified |
| | Brown | 100% (60/60) | Qualified |
| | Yellow | 100% (60/60) | Qualified |
| | Red | 100% (60/60) | Qualified |
| | Green | 100% (60/60) | Qualified |
| | Other-Orange | 100% (60/60) | Qualified |
| | Other-Blue | 100% (60/60) | Qualified |
| | Other-Purple | 100% (60/60) | Qualified |

The Reproducibility (Between-Run) Precision of the URIT UC-1800 Automatic Urine Analyzer was evaluated by using negative urines and spiked urines of known concentrations for each analyte. Each sample was tested for 20 days with 2 runs per day, in 1 time per run in 3 sites, each site with 1 instrument, totally the test performed across 3 instruments with the 3lots of URIT 11FA Urine Reagent Strips and 3lots of URIT 12FA Urine Reagent Strips in each instrument by 3 operators, each operator performing the test for 6-7 days, for a total of 120 measurements at each concentration were tested. All

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URIT MEDICAL ELECTRONIC CO., LTD.

No. D-07 Information Industry District, High-Tech Zone, Guilin, Guangxi 541004, P. R. China

concentrations for all tests had 120 of 120 (100%) match at ± one color block. The results are summarized in Table 12 to Table 15.

Table 12 Summary of Reproducibility (Between-Run) Precision of URIT 11FA Urine Reagent Strips

| Test | Expected Value | | | | | |
| --- | --- | --- | --- | --- | --- | --- |
| Ascorbic acid (mg/dL) | -(0) | +-(10) | +1(25) | +2(50) | +3(100) | |
| Exact agreement | 100% (120/120) | 100% (120/120) | 100% (120/120) | 94.2% (113/120) | 100% (120/120) | |
| ± 1 color block | 100% (120/120) | 100% (120/120) | 100% (120/120) | 100% (120/120) | 100% (120/120) | |
| Conclusion | Qualified | Qualified | Qualified | Qualified | Qualified | |
| Nitrite | -(Negative) | +(Positive) | | | | |
| Exact agreement | 100% (120/120) | 100% (120/120) | | | | |
| ± 1 color block | 100% (120/120) | 100% (120/120) | | | | |
| Conclusion | Qualified | Qualified | | | | |
| Leukocyte(leu/μL) | -(0) | +-(15) | +1(70) | +2(125) | +3(500) | |
| Exact agreement | 100% (120/120) | 100% (120/120) | 100% (120/120) | 100% (120/120) | 100% (120/120) | |
| ± 1 color block | 100% (120/120) | 100% (120/120) | 100% (120/120) | 100% (120/120) | 100% (120/120) | |
| Conclusion | Qualified | Qualified | Qualified | Qualified | Qualified | |
| Ketone (mg/dL) | -(0) | +-(5) | +1(15) | +2(40) | +3(80) | |
| Exact agreement | 100% (120/120) | 100% (120/120) | 100% (120/120) | 100% (120/120) | 100% (120/120) | |
| ± 1 color block | 100% (120/120) | 100% (120/120) | 100% (120/120) | 100% (120/120) | 100% (120/120) | |
| Conclusion | Qualified | Qualified | Qualified | Qualified | Qualified | |
| Urobilinogen (EU/dL) | Normal | | +1(2.0) | +2(4.0) | +3(8.0) | |
| Exact agreement | 100% (120/120) | | 100% (120/120) | 98.3% (118/120) | 100% (120/120) | |
| ± 1 color block | 100% (120/120) | | 100% (120/120) | 100% (120/120) | 100% (120/120) | |
| Conclusion | Qualified | | Qualified | Qualified | Qualified | |
| Bilirubin (mg/dL) | -(0) | | +1(0.5) | +2(2.0) | +3(6.0) | |
| Exact agreement | 100% (120/120) | | 100% (120/120) | 100% (120/120) | 100% (120/120) | |
| ± 1 color block | 100% (120/120) | | 100% (120/120) | 100% (120/120) | 100% (120/120) | |
| Conclusion | Qualified | | Qualified | Qualified | Qualified | |
| Glucose(mg/dL) | -(0) | +-(50) | +1(100) | +2(250) | +3(500) | +4(1000) |
| Exact agreement | 100% (120/120) | 100% (120/120) | 100% (120/120) | 100% (120/120) | 100% (120/120) | 100% (120/120) |
| ± 1 color block | 100% (120/120) | 100% (120/120) | 100% (120/120) | 100% (120/120) | 100% (120/120) | 100% (120/120) |
| Conclusion | Qualified | Qualified | Qualified | Qualified | Qualified | |
| Protein(mg/dL) | -(0) | +-(15) | +1(30) | +2(100) | +3(300) | |
| Exact agreement | 100% (120/120) | 100% (120/120) | 100% (120/120) | 99.2% (119/120) | 100% (120/120) | |
| ± 1 color block | 100% (120/120) | 100% (120/120) | 100% (120/120) | 100% (120/120) | 100% (120/120) | |
| Conclusion | Qualified | Qualified | Qualified | Qualified | Qualified | |
| Specific Gravity | 1.005 | 1.010 | 1.015 | 1.020 | 1.025 | 1.030 |
| Exact agreement | 100% (120/120) | 100% (120/120) | 100% (120/120) | 100% (120/120) | 100% (120/120) | 100% (120/120) |
| ± 1 color block | 100% (120/120) | 100% (120/120) | 100% (120/120) | 100% (120/120) | 100% (120/120) | 100% (120/120) |
| Conclusion | Qualified | Qualified | Qualified | Qualified | Qualified | |
| Blood(CELL/μL) | -(0) | +-(10) | +1(25) | +2(80) | +3(200) | |
| Exact agreement | 100% (120/120) | 100% (120/120) | 100% (120/120) | 95% (114/120) | 97.5% (117/120) | |
| ± 1 color block | 100% (120/120) | 100% (120/120) | 100% (120/120) | 100% (120/120) | 100% (120/120) | |
| Conclusion | Qualified | Qualified | Qualified | Qualified | Qualified | |
| pH | 5.0 | 5.5 | 6.0 | 6.5 | 7.0 | 7.5 |
| Exact agreement | 100% (120/120) | 100% (120/120) | 100% (120/120) | 100% (120/120) | 99.2% (119/120) | 100% (120/120) |

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URIT MEDICAL ELECTRONIC CO., LTD.

No. D-07 Information Industry District, High-Tech Zone, Guilin, Guangxi 541004, P. R. China

| Test | Expected Value | | | | | |
| --- | --- | --- | --- | --- | --- | --- |
| ±1 color block | 100% (120/120) | 100% (120/120) | 100% (120/120) | 100% (120/120) | 100% (120/120) | 100% (120/120) |
| Conclusion | Qualified | Qualified | Qualified | Qualified | Qualified | Qualified |
| pH | 8.0 | 8.5 | 9.0 | | | |
| Exact agreement | 100% (120/120) | 100% (120/120) | 100% (120/120) | | | |
| ±1 color block | 100% (120/120) | 100% (120/120) | 100% (120/120) | | | |
| Conclusion | Qualified | Qualified | Qualified | | | |

Table 13 Summary of Reproducibility (Between-Run) Precision of URIT 12FA Urine Reagent Strips

| Test | Expected Value | | | | | |
| --- | --- | --- | --- | --- | --- | --- |
| Nitrite | -(Negative) | +(Positive) | | | | |
| Exact agreement | 100% (120/120) | 100% (120/120) | | | | |
| ± 1 color block | 100% (120/120) | 100% (120/120) | | | | |
| Conclusion | Qualified | Qualified | | | | |
| Leukocyte(leu/μL) | -(0) | +-(15) | +1(70) | +2(125) | +3(500) | |
| Exact agreement | 100% (120/120) | 100% (120/120) | 100% (120/120) | 100% (120/120) | 100% (120/120) | |
| ± 1 color block | 100% (120/120) | 100% (120/120) | 100% (120/120) | 100% (120/120) | 100% (120/120) | |
| Conclusion | Qualified | Qualified | Qualified | Qualified | Qualified | |
| Ketone (mg/dL) | -(0) | +-(5) | +1(15) | +2(40) | +3(80) | |
| Exact agreement | 100% (120/120) | 100% (120/120) | 100% (120/120) | 100% (120/120) | 100% (120/120) | |
| ± 1 color block | 100% (120/120) | 100% (120/120) | 100% (120/120) | 100% (120/120) | 100% (120/120) | |
| Conclusion | Qualified | Qualified | Qualified | Qualified | Qualified | |
| Urobilinogen (EU/dL) | Normal | | +1(2.0) | +2(4.0) | +3(8.0) | |
| Exact agreement | 100% (120/120) | | 100% (120/120) | 100% (120/120) | 100% (120/120) | |
| ± 1 color block | 100% (120/120) | | 100% (120/120) | 100% (120/120) | 100% (120/120) | |
| Conclusion | Qualified | | Qualified | Qualified | Qualified | |
| Bilirubin (mg/dL) | -(0) | | +1(0.5) | +2(2.0) | +3(6.0) | |
| Exact agreement | 100% (120/120) | | 100% (120/120) | 100% (120/120) | 100% (120/120) | |
| ± 1 color block | 100% (120/120) | | 100% (120/120) | 100% (120/120) | 100% (120/120) | |
| Conclusion | Qualified | | Qualified | Qualified | Qualified | |
| Glucose(mg/dL) | -(0) | +-(50) | +1(100) | +2(250) | +3(500) | +4(1000) |
| Exact agreement | 100% (120/120) | 100% (120/120) | 100% (120/120) | 100% (120/120) | 100% (120/120) | 100% (120/120) |
| ± 1 color block | 100% (120/120) | 100% (120/120) | 100% (120/120) | 100% (120/120) | 100% (120/120) | 100% (120/120) |
| Conclusion | Qualified | Qualified | Qualified | Qualified | Qualified | |
| Protein(mg/dL) | -(0) | +-(15) | +1(30) | +2(100) | +3(300) | |
| Exact agreement | 100% (120/120) | 100% (120/120) | 100% (120/120) | 100% (120/120) | 100% (120/120) | |
| ± 1 color block | 100% (120/120) | 100% (120/120) | 100% (120/120) | 100% (120/120) | 100% (120/120) | |
| Conclusion | Qualified | Qualified | Qualified | Qualified | Qualified | |
| Specific Gravity | 1.005 | 1.010 | 1.015 | 1.020 | 1.025 | 1.030 |
| Exact agreement | 100% (120/120) | 100% (120/120) | 100% (120/120) | 100% (120/120) | 100% (120/120) | 100% (120/120) |
| ± 1 color block | 100% (120/120) | 100% (120/120) | 100% (120/120) | 100% (120/120) | 100% (120/120) | |
| Conclusion | Qualified | Qualified | Qualified | Qualified | Qualified | |

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URIT MEDICAL ELECTRONIC CO., LTD.

No. D-07 Information Industry District, High-Tech Zone, Guilin, Guangxi 541004, P. R. China

| Test | Expected Value | | | | | |
| --- | --- | --- | --- | --- | --- | --- |
| pH | 5.0 | 5.5 | 6.0 | 6.5 | 7.0 | 7.5 |
| Exact agreement | 100% (120/120) | 100% (120/120) | 100% (120/120) | 100% (120/120) | 100% (120/120) | 100% (120/120) |
| ± 1 color block | 100% (120/120) | 100% (120/120) | 100% (120/120) | 100% (120/120) | 100% (120/120) | 100% (120/120) |
| Conclusion | Qualified | Qualified | Qualified | Qualified | Qualified | Qualified |
| pH | 8.0 | 8.5 | 9.0 | | | |
| Exact agreement | 100% (120/120) | 100% (120/120) | 100% (120/120) | | | |
| ± 1 color block | 100% (120/120) | 100% (120/120) | 100% (120/120) | | | |
| Conclusion | Qualified | Qualified | Qualified | | | |
| Microalbumin | 10mg/L | 30mg/L | 80mg/L | 150mg/L | | |
| Exact agreement | 100% (120/120) | 100% (120/120) | 100% (120/120) | 100% (120/120) | | |
| ± 1 color block | 100% (120/120) | 100% (120/120) | 100% (120/120) | 100% (120/120) | | |
| Conclusion | Qualified | Qualified | Qualified | Qualified | | |
| Creatinine | 10 mg/dL | 50 mg/dL | 100 mg/dL | 200 mg/dL | 300 mg/dL | |
| Exact agreement | 100% (120/120) | 100% (120/120) | 100% (120/120) | 100% (120/120) | 100% (120/120) | |
| ± 1 color block | 100% (120/120) | 100% (120/120) | 100% (120/120) | 100% (120/120) | 100% (120/120) | |
| Conclusion | Qualified | Qualified | Qualified | Qualified | Qualified | |

Table 14 Summary of Reproducibility (Between- Run) Precision of Physical Module Item Turbidity

| Test | Expected Value | | | |
| --- | --- | --- | --- | --- |
| Turbidity | Clear | Micro turbid | Turbid | Very turbid |
| Exact agreement | 100% (120/120) | 100% (120/120) | 100% (120/120) | 100% (120/120) |
| ± 1 Block | 100% (120/120) | 100% (120/120) | 100% (120/120) | 100% (120/120) |
| Conclusion | Qualified | Qualified | Qualified | Qualified |

Table 15 Summary of Reproducibility (Between- Run) Precision of Physical Module Item Color

| Test | Color | Exact agreement | Conclusion |
| --- | --- | --- | --- |
| Expected Value | Colorless | 100% (120/120) | Qualified |
| | Brown | 100% (120/120) | Qualified |
| | Yellow | 100% (120/120) | Qualified |
| | Red | 100% (120/120) | Qualified |
| | Green | 100% (120/120) | Qualified |
| | Other-Orange | 100% (120/120) | Qualified |
| | Other-Blue | 100% (120/120) | Qualified |
| | Other-Purple | 100% (120/120) | Qualified |

# b Linearity/assay reportable range

The assay reportable range was evaluated by measuring the samples containing known concentrations of all measurement blocks. Prepare the reference solutions according to the marked values of concentration for each item on the URIT 11FA and 12FA urine reagent strips, and conduct linear range/reportable range experiments on the instrument with the reference solutions. Test each reference solution on three UC-1800 machines with three batches of reagent strips. Repeat the test for each batch of test strip for 21 times on each instrument.

The results of assay reportable range of URIT 11FA Urine Reagent Strips and URIT 12FA Urine Reagent Strips are summarized as Table 16 to Table 18 show below. The Summary of Reportable Results of URIT 11FA Urine Reagent Strips and URIT 12FA Urine Reagent Strips are summarized as Table 19 show below.

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URIT MEDICAL ELECTRONIC CO., LTD.

No. D-07 Information Industry District, High-Tech Zone, Guilin, Guangxi 541004, P. R. China

Table 16 Summary of Linearity of URIT 11/12FA Urine Reagent Strips -common analytes

| Analyte | URIT 11/12 FA Urine Reagent Strips (Common Item) | | | | |
| --- | --- | --- | --- | --- | --- |
| | Qualitative Rank | Semi-Quantitative Rank | Concentration/Level Tested | Agreement at same block | Agreement within +/- one block |
| Leukocyte | - | 0 | 0 leu/mcL | 100% (63/63) | 100% (63/63) |
| | +/- | 15 | 15 leu/mcL | 100% (63/63) | 100% (63/63) |
| | +1 | 70 | 70 leu/mcL | 100% (63/63) | 100% (63/63) |
| | +2 | 125 | 125 leu/mcL | 100% (63/63) | 100% (63/63) |
| | +3 | 500 | 500 leu/mcL | 100% (63/63) | 100% (63/63) |
| Ketones | - | 0 | 0 mg/dL | 100% (63/63) | 100% (63/63) |
| | +/- | 5 | 5 mg/dL | 100% (63/63) | 100% (63/63) |
| | +1 | 15 | 15 mg/dL | 100% (63/63) | 100% (63/63) |
| | +2 | 40 | 40 mg/dL | 100% (63/63) | 100% (63/63) |
| | +3 | 80 | 80 mg/dL | 100% (63/63) | 100% (63/63) |
| Urobilinogen | Normal | Normal | Normal | 100% (63/63) | 100% (63/63) |
| | +1 | 2.0 | 2.0 mg/dL | 100% (63/63) | 100% (63/63) |
| | +2 | 4.0 | 4.0 mg/dL | 100% (63/63) | 100% (63/63) |
| | +3 | 8.0 | 8.0 mg/dL | 100% (63/63) | 100% (63/63) |
| Bilirubin | - | 0 | 0 mg/dL | 100% (63/63) | 100% (63/63) |
| | +1 | 0.5 | 0.5 mg/dL | 100% (63/63) | 100% (63/63) |
| | +2 | 2.0 | 2.0 mg/dL | 100% (63/63) | 100% (63/63) |
| | +3 | 6.0 | 6.0 mg/dL | 100% (63/63) | 100% (63/63) |
| Glucose | - | 0 | 0 mg/dL | 100% (63/63) | 100% (63/63) |
| | +/- | 50 | 50 mg/dL | 100% (63/63) | 100% (63/63) |
| | +1 | 100 | 100 mg/dL | 100% (63/63) | 100% (63/63) |
| | +2 | 250 | 250 mg/dL | 100% (63/63) | 100% (63/63) |
| | +3 | 500 | 500 mg/dL | 100% (63/63) | 100% (63/63) |
| | +4 | 1000 | 1000 mg/dL | 100% (63/63) | 100% (63/63) |
| Protein | - | 0 | 0 mg/dL | 100% (63/63) | 100% (63/63) |
| | +/- | 15 | 15 mg/dL | 100% (63/63) | 100% (63/63) |
| | +1 | 30 | 30 mg/dL | 100% (63/63) | 100% (63/63) |
| | +2 | 100 | 100 mg/dL | 100% (63/63) | 100% (63/63) |
| | +3 | 300 | 300 mg/dL | 100% (63/63) | 100% (63/63) |
| Blood | - | 0 | 0 ery/mcL | 100% (63/63) | 100% (63/63) |
| | +/- | 10 | 10 ery/mcL | 100% (63/63) | 100% (63/63) |
| | +1 | 25 | 25 ery/mcL | 100% (63/63) | 100% (63/63) |
| | +2 | 80 | 80 ery/mcL | 100% (63/63) | 100% (63/63) |
| | +3 | 200 | 200 ery/mcL | 100% (63/63) | 100% (63/63) |
| Specific Gravity | N/A | 1.005 | 1.005 | 100% (63/63) | 100% (63/63) |
| | | 1.010 | 1.010 | 100% (63/63) | 100% (63/63) |
| | | 1.015 | 1.015 | 100% (63/63) | 100% (63/63) |
| | | 1.020 | 1.020 | 100% (63/63) | 100% (63/63) |
| | | 1.025 | 1.025 | 100% (63/63) | 100% (63/63) |
| | | 1.030 | 1.030 | 100% (63/63) | 100% (63/63) |
| pH | N/A | 5.0 | 5.0 | 100% (63/63) | 100% (63/63) |
| | | 5.5 | 5.5 | 100% (63/63) | 100% (63/63) |

{23}

No. D-07 Information Industry District, High-Tech Zone, Guilin, Guangxi 541004, P. R. China

URIT MEDICAL ELECTRONIC CO., LTD.

| Analyte | URIT 11/12 FA Urine Reagent Strips (Common Item) | | | | |
| --- | --- | --- | --- | --- | --- |
| | Qualitative Rank | Semi-Quantitative Rank | Concentration/Level Tested | Agreement at same block | Agreement within +/- one block |
| | | 6.0 | 6.0 | 100% (63/63) | 100% (63/63) |
| | | 6.5 | 6.5 | 100% (63/63) | 100% (63/63) |
| | | 7.0 | 7.0 | 100% (63/63) | 100% (63/63) |
| | | 7.5 | 7.5 | 100% (63/63) | 100% (63/63) |
| | | 8.0 | 8.0 | 100% (63/63) | 100% (63/63) |
| | | 8.5 | 8.5 | 100% (63/63) | 100% (63/63) |
| | | 9.0 | 9.0 | 100% (63/63) | 100% (63/63) |

Table 17 Summary of Linearity of URIT 11FA Urine Reagent Strips

| Analyte | URIT 11 FA Urine Reagent Strips | | | | |
| --- | --- | --- | --- | --- | --- |
| | Qualitative Rank | Semi-Quantitative Rank | Concentration/Level Tested | Agreement at same block | Agreement within +/- one block |
| Ascorbic acid | - | 0 | 0mg/dL | 100% (63/63) | 100% (63/63) |
| | +1 | 10 | 10mg/dL | 100% (63/63) | 100% (63/63) |
| | +2 | 25 | 25mg/dL | 100% (63/63) | 100% (63/63) |
| | +3 | 50 | 50mg/dL | 100% (63/63) | 100% (63/63) |
| | +4 | 100 | 100mg/dL | 100% (63/63) | 100% (63/63) |

Table 18 Summary of Report range of URIT 12FA Urine Reagent Strips

| Analyte | URIT 12FA Urine Reagent Strips (Microalbumin & Creatinine) | | | |
| --- | --- | --- | --- | --- |
| | Semi-Quantitative Rank | Concentration/Level Tested | Agreement at same block | Agreement within +/- one block |
| Microalbumin | 10 | 10mg/L | 100% (63/63) | 100% (63/63) |
| | 30 | 30mg/L | 100% (63/63) | 100% (63/63) |
| | 80 | 80mg/L | 100% (63/63) | 100% (63/63) |
| | 150 | 150mg/L | 100% (63/63) | 100% (63/63) |
| Creatinine | 10 | 10mg/dL | 100% (63/63) | 100% (63/63) |
| | 50 | 50mg/dL | 100% (63/63) | 100% (63/63) |
| | 100 | 100mg/dL | 100% (63/63) | 100% (63/63) |
| | 200 | 200mg/dL | 100% (63/63) | 100% (63/63) |
| | 300 | 300mg/dL | 100% (63/63) | 100% (63/63) |

Table 19 Summary of Reportable Results of URIT 11/12FA Urine Reagent Strips

| Item | URIT Urine Reagent Strips | |
| --- | --- | --- |
| | 11FA | 12FA |
| Ascorbic acid | 0, 10, 25, 50, 100 mg/dL | N/A |
| | -, +/-, +1, +2, +3 | N/A |
| Microalbumin | N/A | 10,30,80,150 mg/L |
| Leukocyte | 0, 15, 70, 125, 500 leu/mcL | |
| | -, +/-, +1, +2, +3 | |
| Creatinine | N/A | 10,50,100,200,300 mg/dL |
| Ketone | 0,5,15,40,80 mg/dL | |
| | -, +/-, +1, +2, +3 | |
| Urobilinogen | Normal,2.0,4.0,8.0 EU/dL | |
| | Normal, +1, +2, +3 | |

{24}

URIT MEDICAL ELECTRONIC CO., LTD.

No. D-07 Information Industry District, High-Tech Zone, Guilin, Guangxi 541004, P. R. China

| Item | URIT Urine Reagent Strips | |
| --- | --- | --- |
| | 11FA | 12FA |
| Bilirubin | 0,0.5,2.0,6.0mg/dL | |
| | -,+1,+2,+3 | |
| Glucose | 0,50,100,250,500,1000 mg/dL | |
| | -,+/-,+1,+2,+3,+4 | |
| Protein | 0,15,30,100,300 mg/dL | |
| | -,+/-,+1,+2,+3 | |
| Blood | 0,10,25,80,200 ery/mcL | |
| | -,+/-,+1,+2,+3 | |
| Specific Gravity | 1.005, 1.010, 1.015, 1.020, 1.025, 1.030 | |
| pH | 5.0, 5.5, 6.0, 6.5, 7.0, 7.5, 8.0, 8.5, 9.0 | |

## c Analytical Sensitivity

The results of Analytical Sensitivity of URIT 11FA Urine Reagent Strips and URIT 12FA Urine Reagent Strips are summarized as Table 20.

**Table 20 Summary of Analytical Sensitivity of Urine Reagent Strips**

| Item | URIT Urine Reagent Strips | |
| --- | --- | --- |
| | 11FA | 12FA |
| Ascorbic acid | 8~10mg/dL | N/A |
| Nitrite | 0.1-0.2mg/dL | |
| Microalbumin | N/A | 20-30mg/L |
| Leukocyte | 10~15leu/mcL | |
| Creatinine | N/A | 25~50mg/dL |
| Ketone | 4~5mg/dL | |
| Urobilinogen | 1~2EU/dL | |
| Bilirubin | 0.4~0.5mg/dL |…