DUS 2GP Reagent Strips, DUS 5 Reagent Strips, DUS 10 Reagent Strips

K181024 · DFI Co., Ltd. · JIL · May 23, 2018 · Clinical Chemistry

Device Facts

• Record ID: K181024
• Device Name: DUS 2GP Reagent Strips, DUS 5 Reagent Strips, DUS 10 Reagent Strips
• Applicant: DFI Co., Ltd.
• Product Code: JIL · Clinical Chemistry
• Decision Date: May 23, 2018
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1340
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

This device is intended for the in vitro measurement of the following in urine: Leukocyte, Nitrite, Urobilinogen, Protein, pH, Blood, Specific gravity, Ketone, Bilirubin, Glucose. These strips are intended for prescription, in vitro diagnostic use only and they are visually read. DUS 2GP reagent strips provide qualitative and semiquantitative measurements for protein, and glucose in urine specimens. Test results may provide information regarding the status of carbohydrate metabolism and kidney function. DUS 5 reagent strips provide qualitative and semiquantitative measurements for leukocytes, nitrite, blood , protein, and glucose in urine specimens. These measurements are used to aid in the diagnosis of metabolic disorders, kidney function anomalies and urinary tract infections. DUS 10 reagent strips provide qualitative and semiquantitative measurements for specific gravity, pH, leukocytes, nitrite, protein, glucose, ketone, urobilinogen, bilirubin and blood in urine speciments are used to aid in the diagnosis of metabolic disorders, kidney function anomalies, urinary tract infections and liver function.

Device Story

DUS Series (2GP, 5, 10) are urine reagent strips with multiple pads affixed to plastic strips; pads react with urine analytes to produce visible color changes. Used in clinical settings by medical technicians; results obtained by visual comparison against a color chart on the container. Provides qualitative and semiquantitative measurements for leukocytes, nitrite, urobilinogen, protein, pH, blood, specific gravity, ketone, bilirubin, and glucose. Results aid clinicians in diagnosing metabolic disorders, kidney function anomalies, urinary tract infections, and liver function. Benefits include rapid, point-of-care screening for various physiological conditions.

Clinical Evidence

Bench testing only. Method comparison study conducted at three clinical sites with 867 fresh urine samples compared against the predicate (Multistix 10SG). Precision/reproducibility tested per CLSI EP5-A3 using 90 replicates per level. Analytical specificity and interference studies evaluated potential cross-reactivity with various drugs and substances. Results showed high agreement (exact or within one color block) across all analytes.

Technological Characteristics

Plastic strips with reagent pads for colorimetric analysis. Analyte detection via chemical reaction producing visible color change. Dimensions/form factor: standard reagent strip. Connectivity: none (visual read). Sterilization: not specified. Software: none.

Indications for Use

Indicated for prescription, in vitro diagnostic use in patients requiring urine analysis for metabolic disorders, kidney function anomalies, urinary tract infections, or liver function. Applicable to all ages and genders.

Regulatory Classification

Identification

A urinary glucose (nonquantitative) test system is a device intended to measure glucosuria (glucose in urine). Urinary glucose (nonquantitative) measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, hypoglycemia, and hyperglycemia.

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image contains the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.

May 23, 2018

DFI Co., Ltd. % Ho Dong Yang, CEO Onbix Corporation #821 Samil Plaza, 14, Dogok-ro 1-Gil, Gangnam-gu Seoul, 06523 Korea

Re: K181024

Trade/Device Name: DUS 2GP Reagent Strips, DUS 5 Reagent Strips, DUS 10 Reagent Strips Regulation Number: 21 CFR 862.1340 Regulation Name: Urinary glucose (nonguantitative) test system Regulatory Class: Class II Product Code: JIL, JIO, JIR, LJX, JMT, CDM, CEN, JRE, JIN, JJB Dated: April 11, 2018 Received: April 18, 2018

Dear Ho Dong Yang:

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 (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. 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.

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 of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR

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Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

# Kellie B. Kelm -S

for Courtney H. Lias, Ph.D. Director Division of Chemistry and Toxicology Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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## Indications for Use

510(k) Number (if known) K181024

Device Name

DUS 2GP Reagent Strips, DUS 5 Reagent Strips, DUS 10 Reagent Strips

#### Indications for Use (Describe)

DUS 2GP Reagent Strips, DUS 5 Reagent Strips, DUS 10 Reagent Strips

This device is intended for the in vitro measurement of the following in urine: Leukocyte, Nitrite, Urobilinogen, Protein, pH, Blood, Specific gravity, Ketone, Bilirubin, Glucose. These strips are intended for prescription, in vitro diagnostic use only and they are visually read.

DUS 2GP reagent strips provide qualitative and semiquantitative measurements for protein, and glucose in urine specimens. Test results may provide information regarding the status of carbohydrate metabolism and kidney function.

DUS 5 reagent strips provide qualitative and semiquantitative measurements for leukocytes, nitrite, blood , protein, and glucose in urine specimens. These measurements are used to aid in the diagnosis of metabolic disorders, kidney function anomalies and urinary tract infections.

DUS 10 reagent strips provide qualitative and semiquantitative measurements for specific gravity, pH, leukocytes, nitrite, protein, glucose, ketone, urobilinogen, bilirubin and blood in urine speciments are used to aid in the diagnosis of metabolic disorders, kidney function anomalies, urinary tract infections and liver function.

| Type of Use (Select one or both, as applicable) | |
|---------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------|
| <div> <span> <span style="font-size: 10px;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) </span> </div> | <div> <span> <span style="font-size: 10px;">□</span> Over-The-Counter Use (21 CFR 801 Subpart C) </span> </div> |

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# 510(k) SUMMARY [K181024]

This 510(k) summary is being submitted in accordance with the requirements of 21 CFR §807.92.

| Submitter Information: | DFI Co., Ltd.<br>388-25, Gomo-ro, Jillye-myeon, Gimhae-si,<br>Gyeongsangnam-do, 621-881, Korea<br>Tel. [phone] Fax: [phone] |
|------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Ho Dong, Yang<br>Onbix Corporation<br>#821 Samil Plaza, 14, Dogokro 1-gil Gangnam-gu<br>Seoul, Korea (06253)<br>Tel: *82-2-566-3360 / Fax: *82-2-6280-3360<br>Email: [e-mail] |

Date Summary Prepared: May 17, 2018

| Device Information: | |
|---------------------|---------------------------------------------------------------------|
| Trade Name(s): | DUS 2GP Reagent Strips, DUS 5 Reagent Strips, DUS 10 Reagent Strips |
| Common Name: | urinary test system |
| Panel: | clinical chemistry |

# Regulatory information

| Name | Regulation | Product<br>code | Device<br>class |
|-----------------------------------------------------------------------|-----------------|-----------------|-----------------|
| Urinary Glucose<br>(non-quantitative) test system | 21 CFR 862.1340 | JIL | II |
| Occult Blood test | 21 CFR 864.6550 | JIO | II |
| Urinary Protein or Albumin<br>(nonquantitative) test system | 21 CFR 862.1645 | JIR | I |
| Leukocyte peroxidase test | 21 CFR 864.7675 | LJX | I |
| Nitrite (nonquantitative) test system | 21 CFR 862.1510 | JMT | I |
| Urinary Urobilinogen<br>(nonquantitative) test system | 21 CFR 862.1785 | CDM | I |
| Urinary pH (nonquantitative) test | 21 CFR 862.1550 | CEN | I |
| Specific Gravity | 21CFR 862.2800 | JRE | I |
| Ketones (nonquantitative) test<br>system | 21 CFR 862.1435 | JIN | I |
| Urinary Bilirubin and its conjugates<br>(nonquantitative) test system | 21 CFR 862.1115 | JJB | I |

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#### Predicate Device Information:

K992257 / MULTISTIX 10 SG

#### Device Description:

DUS 2GP Reagent Strips, DUS 5 Reagent Strips, DUS 10 Reagent Strips

The DUS Series are urine test strips with different reagent pads for the determination of specific gravity, pH, leukocytes, nitrite, protein, glucose, ketone, urobilinogen, bilirubin and blood affixed onto plastic strips. of which leukocyte, nitrite, urobilinogen, protein, pH, blood, specific gravity, ketone, bilirubin and glucose reagent pads are affixed onto the plastic strips. The reagent pads react with analytes in the urine giving a visible color. Results are confirmed by comparison of the test strip with the color chart on the container. For each color result for each analyte, a semiquantitative value is available on the box label (e.g. bilirubin results include negative, 1, 2, and 4 mg/dL) and the associated qualitative result (e.g. bilirubin results include negative. +. ++, +++).

#### Indications for Use:

This device is intended for the in vitro measurement of the following in urine: Leukocyte, Nitrite, Urobilinogen, Protein, pH, Blood, Specific gravity, Ketone, Bilirubin, Glucose. These strips are intended for prescription, in vitro diagnostic use only and they are visually read.

DUS 2GP reagent strips provide qualitative and semiquantitative measurements for protein and glucose in urine specimens. Test results may provide information regarding the status of carbohydrate metabolism and kidney function.

DUS 5 reagent strips provide qualitative and semiquantitative measurements for leukocytes, nitrite, blood, protein, and glucose in urine specimens. These measurements are used to aid in the diagnosis of metabolic disorders and kidney function anomalies and urinary tract infections.

DUS 10 reagent strips provide qualitative and semiquantitative measurements for specific gravity, pH. leukocytes, nitrite, protein, glucose, ketone, urobilinogen, bilirubin a n d blood in urine specimens. These measurements are used to aid in the diagnosis of metabolic disorders, kidney function anomalies, urinary tract infections and liver function.

## Comparison to Predicate Device(s):

This device is equivalent to the predicate devices in its intended use and technological characteristics, including:

indications for use technological characteristics performance properties

#### Summary of testing:

The performance characteristics of the candidate strips were verified by method comparison, precision, detection limit, interference and specificity studies.

Testing is summarized below.

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#### 1. Performance Characteristics

DUS 10 reagent strips were used for all analytical studies, because DUS 2GP and DUS 5 reagent strips contain subsets of the analytes in the DUS 10 reagent strips.

#### a) Precision/Reproducibility

Precision testing was done in accordance with CLSI EP5-A3.. The repeatability/ reproducibility were determined at three clinical sites, using commercially available control solutions. Studies were performed by medical technicians, using 2 levels of commercially available urine based control solutions. For within-run precision studies, 10 test strips from 3 different lots at 3 sites were tested (30 tests at each site = 90 replicates per level). For within-day precision studies, 1 test strip a day from 3 different lots was tested at 3 sites for 10 days (30 tests at each site = 90 replicates per level). The results are summarized below:

| Level 1 control | | | | | |
|-----------------|--------------|---------------------------|-------------------------------------------|---------------------------|-------------------------------------------|
| | | Within-run (n=90) | | Within-day (n=90) | |
| Item | Test Results | Exact<br>agreement<br>(%) | Agreement<br>within<br>+/-one<br>block(%) | Exact<br>agreement<br>(%) | Agreement<br>within<br>+/-one<br>block(%) |
| Urobilinogen | Normal | 100 | 100 | 100 | 100 |
| Glucose | Negative | 100 | 100 | 100 | 100 |
| Bilirubin | Negative | 100 | 100 | 100 | 100 |
| Ketones | Negative | 100 | 100 | 100 | 100 |
| SG | 1.020 | 100 | 100 | 100 | 100 |
| Blood | Negative | 100 | 100 | 100 | 100 |
| pH | 6 | 100 | 100 | 100 | 100 |
| Protein | Negative | 100 | 100 | 100 | 100 |
| Nitrite | Negative | 100 | 100 | 100 | 100 |
| Leukocytes | Negative | 100 | 100 | 100 | 100 |

| Level 2 control | | | | | |
|-----------------|--------------|---------------------------|-------------------------------------------|---------------------------|-------------------------------------------|
| | | Within-run (n=90) | | Within-day (n=90) | |
| Item | Test Results | Exact<br>agreement<br>(%) | Agreement<br>within<br>+/-one<br>block(%) | Exact<br>agreement<br>(%) | Agreement<br>within<br>+/-one<br>block(%) |
| Urobilinogen | 4mg/dL | 100 | 100 | 100 | 100 |
| Glucose | 1000mg/dL | 100 | 100 | 100 | 100 |
| Bilirubin | 4mg/dL | 100 | 100 | 100 | 100 |
| Ketones | 40mg/dL | 100 | 100 | 100 | 100 |
| SG | 1.020 | 98.9 | 100 | 100 | 100 |
| Blood | 200 RBC/uL | 100 | 100 | 100 | 100 |
| pH | 7 | 100 | 100 | 98.9 | 100 |
| Protein | 100 mg/dL | 100 | 100 | 100 | 100 |
| Nitrite | Pos | 100 | 100 | 100 | 100 |
| Leukocytes | 70 WBC/uL | 100 | 100 | 100 | 100 |

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## b) Linearity /assay reportable range.

Linearity / assay reportable range was evaluated in-house. Samples were created by spiking known concentration of each standard material or by serial dilution of a high concentration urine sample with negative urine. Testing was performed by 3 medical technicians using 3 lots of test strips. Each concentration level was tested in 10 replicates with each lot of test strips. The results are summarized below:

| Analyte | Urine sample<br>concentration | Color block<br>output | % Exact match |
|------------------|-------------------------------|-----------------------|----------------|
| Urobilinogen | Negative/Norm | 0.1 | 100 % (90/90) |
| | 1 mg/dL | 1 mg/dL | 100 % (90/90) |
| | 2 mg/dL | 2 mg/dL | 97.7 % (88/90) |
| | 4 mg/dL | 4 mg/dL | 98.8 % (89/90) |
| | 8 mg/dL | 8 mg/dL | 98.8 % (89/90) |
| Glucose | Negative | Neg. | 100 % (90/90) |
| | 100 mg/dL | ±(100 mg/dL) | 100 % (90/90) |
| | 250 mg/dL | +(250 mg/dL) | 97.7 % (88/90) |
| | 500 mg/dL | ++(500 mg/dL) | 98.8 % (89/90) |
| | 1000 mg/dL | +++(1000 mg/dL) | 97.7 % (88/90) |
| | 2000 mg/dL | ++++(2000<br>mg/dL) | 100 % (90/90) |
| Bilirubin | Negative | Neg. | 100 % (90/90) |
| | 1 mg/dL | + | 98.8 % (89/90) |
| | 2 mg/dL | ++ | 96.6 % (87/90) |
| | 4 mg/dL | +++ | 100 % (90/90) |
| Ketones | Negative | Neg. | 100 % (90/90) |
| | 5 mg/dL | ±(5 mg/dL) | 100 % (90/90) |
| | 15 mg/dL | +(15 mg/dL) | 97.7 % (88/90) |
| | 40 mg/dL | ++(40 mg/dL) | 98.8 % (89/90) |
| | 80 mg/dL | +++(80 mg/dL) | 98.8 % (89/90) |
| 160 mg/dL | ++++(160 mg/dL) | 100 % (90/90) | |
| Analyte | Urine sample<br>concentration | Color block<br>output | % Exact match |
| Specific gravity | 1.000 | 1.000 | 100 % (90/90) |
| | 1.005 | 1.005 | 94.4 % (85/90) |
| | 1.010 | 1.010 | 100 % (90/90) |
| | 1.015 | 1.015 | 96.6 % (87/90) |
| | 1.020 | 1.020 | 97.7 % (88/90) |
| | 1.025 | 1.025 | 96.6 % (87/90) |
| | 1.030 | 1.030 | 100 % (90/90) |
| Nitrite | Negative | Neg. | 100% (90/90) |
| | 0.05 mg/dL | Trace | 100 % (90/90) |
| | 10 mg/dL | Pos | 100 % (90/90) |
| Blood | Negative | Neg. | 100 % (90/90) |
| | 10 RBC/μL | Trace | 100 % (90/90) |
| | 25 RBC/μL | +(25 RBC/μL) | 98.8 % (89/90) |
| | 80 RBC/μL | ++(80 RBC/μL) | 100 % (90/90) |
| | 200 RBC/μL | +++(200RBC/μL) | 100 % (90/90) |
| pH | 5 | 5 | 100 % (90/90) |
| | 6 | 6 | 98.8 % (89/90) |
| | 6.5 | 6.5 | 98.8 % (89/90) |
| | 7 | 7 | 97.7 % (88/90) |
| | 7.5 | 7.5 | 97.7 % (88/90) |
| | 8 | 8 | 98.8 % (89/90) |
| | 8.5 | 8.5 | 100% (90/90) |
| Protein | Negative | Neg. | 100 % (90/90) |
| | 15 mg/dL | Trace | 98.8 % (89/90) |
| | 30 mg/dL | +(30 mg/dL) | 98.8 % (89/90) |
| | 100 mg/dL | ++(100 mg/dL) | 96.6 % (87/90) |
| | 300 mg/dL | +++(300 mg/dL) | 97.7 % (88/90) |
| | 100 mg/dL | +++++(1000 mg/dL) | 100 % (90/90) |
| Leukocytes | Negative | Neg. | 100 % (90/90) |
| | 15 WBC/μL | Trace | 100 % (90/90) |
| | 70 WBC/μL | +(70 WBC/μL) | 97.7 % (88/90) |
| | 125 WBC/μL | ++(125 WBC/μL) | 97.7 % (88/90) |
| | 500 WBC/μL | +++(500 WBC/μL) | 100 % (90/90) |

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## c) Detection limit

A sensitivity study was performed to evaluate the limits of detection for each of the analytes. Negative urine was spiked with standard materials to obtain 3 levels across the measuring range for each analyte concentration. 90 replicates were obtained for each concentration (each sample concentration was analyzed 30 times using 3 reagent strip lots). Sensitivity was defined as the cutoff for which ≥95% of the contrived pooled measurements were trace or the first positive result.

| Urobilinogen | | | |
|----------------|----------|------------------------|---------------------------|
| Conc. | Negative | Positive<br>(+ 2mg/dL) | Positive Agreement<br>(%) |
| 1.8 mg/dL | 8 | 82 | 91.1% |
| 2 mg/dL | 0 | 90 | 100% |
| 2.3 mg/dL | 0 | 90 | 100% |
| Result cut off | | 2 mg/dL | |

| Glucose | | | |
|----------------|----------|--------------|--------------------|
| Conc. | Negative | Positive | Positive Agreement |
| | | (± 100mg/dL) | (%) |
| 80 mg/dL | 5 | 85 | 94.4% |
| 100 mg/dL | 0 | 90 | 100% |
| 120 mg/dL | 0 | 90 | 100% |
| Result cut off | 100mg/dL | | |

| Bilirubin | | | |
|----------------|-----------|--------------------------|---------------------------|
| Conc. | Negative | Positive<br>(+ 1.0mg/dL) | Positive Agreement<br>(%) |
| 0.8 mg/dL | 6 | 84 | 93.3% |
| 1.0 mg/dL | 0 | 90 | 100% |
| 1.2 mg/dL | 0 | 90 | 100% |
| Result cut off | 1.0 mg/dL | | |

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| Ketones | | | |
|----------------|----------|------------|--------------------|
| Conc. | Negative | Positive | Positive Agreement |
| | | (± 5mg/dL) | (%) |
| 4 mg/dL | 5 | 85 | 94.4% |
| 5 mg/dL | 0 | 90 | 100% |
| 6 mg/dL | 0 | 90 | 100% |
| Result cut off | 5 mg/dL | | |

| Blood | | | |
|----------------|-----------|-------------|--------------------|
| | | Positive | Positive Agreement |
| Conc. | Negative | (±5 RBC/μL) | (%) |
| 8 RBC/μL | 7 | 83 | 92.2% |
| 10 RBC/μL | 0 | 90 | 100% |
| 12 RBC/μL | 0 | 90 | 100% |
| Result cut off | 10 RBC/μL | | |

| Protein | | | |
|----------------|----------|-------------------------|---------------------------|
| | Negative | Positive<br>(±15 mg/dL) | Positive Agreement<br>(%) |
| Conc. | | | |
| 12mg/dL | 6 | 84 | 93.3% |
| 15mg/dL | 0 | 90 | 100% |
| 18mg/dL | 0 | 90 | 100% |
| Result cut off | 15mg/dL | | |

| Nitrite | | | |
|----------------|-----------|--------------|--------------------|
| | | Positive | Positive Agreement |
| Conc. | Negative | (0.05 mg/dL) | (%) |
| 0.04mg/dL | 6 | 84 | 93.3% |
| 0.05mg/dL | 0 | 90 | 100% |
| 0.06mg/dL | 0 | 90 | 100% |
| Result cut off | 0.05mg/dL | | |

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| Leukocytes | | | |
|----------------|-----------|---------------------------------|---------------------------|
| Conc. | Negative | Positive<br>(Trace<br>15WBC/μL) | Positive Agreement<br>(%) |
| 12 WBC/μL | 5 | 85 | 94.4% |
| 15 WBC/μL | 0 | 90 | 100% |
| 18WBC/μL | 0 | 90 | 100% |
| Result cut off | 15 WBC/μL | | |

The reportable ranges for each analyte are summarized below:

| Test | Reportable Range |
|------------------|---------------------------------------------|
| Urobilinogen | Qualitative: normal to 3+ |
| | Semi-quantitative: 0.1 to 8 mg/dL |
| Glucose | Qualitative: Negative to 4+ |
| | Semi-quantitative : Negative to 2000 mg/dL |
| Bilirubin | Qualitative: Negative to 3+ |
| | Semi-quantitative : Negative to 4 mg/dL |
| Ketones | Qualitative: Negative to 4+ |
| | Semi-quantitative : Negative to 160 mg/dL |
| Specific Gravity | Semi-quantitative : 1.000 to 1.030 |
| Blood | Qualitative: Negative to 3+ |
| | Semi-quantitative : Negative to 200 RBC/ μL |
| pH | Semi-quantitative : 5 to 8.5 |
| Protein | Qualitative: Negative to 4+ |
| | Semi-quantitative : Negative to 1000 mg/dL |
| Nitrite | Qualitative: Negative to Pos |
| | Semi-quantitative : Negative to 10 mg/dL |
| Leukocytes | Qualitative: Negative to 3+ |
| | Semi-quantitative : Negative to 500 WBC/μL |

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#### d) Analytical specificity

Potential interferents and drugs were evaluated to assess their interfering effect on the performance of DUS 10 test strips. Urine sample pools prepared at 3 analyte concentrations (negative, low positive and high positive) were spiked with potential interfering substances at various interference concentrations and analyzed in 3 replicates using 3 lots of DUS 10 test strips. Interference was defined as change in output of ±1 color block between the spiked and unspiked control sample. No interference was observed for the following compounds at the concentrations evaluated below:

| Potential Interfering Substance | Highest concentration at which<br>no interference was observed |
|----------------------------------|----------------------------------------------------------------|
| Albumin (protein) | 750 mg/dL |
| Ascorbic acid | 15 mg/dL |
| Acetaminophen | 25 mg/dL |
| Azo gantrinsin (Sulfamethoxazol) | 140 mg/dL |
| Bilirubin | 3 mg/dL |
| Captropril | 100 mg/dL |
| Sodium hypochlorite | 0.1% |
| Creatinine | 800 mg/dL |
| Nitrofurantoin | 10 mg/dL |
| Oxalic acid | 30 mg/dL |
| p-amino Salicylic acid | 375 mg/dL |
| β-D-Glucose (Glucose) | 1000 mg/dL |
| Phenazopyridine | 25 mg/dL |
| Riboflavin | 12 mg/dL |
| Selenium | 150 mg/dL |
| Forrmaldehyde | 100 mg/dL |
| Hemoglobin | 3 mg/dL |
| Lithium acetoacetate (ketones) | 20 mg/dL |
| Tetracycline | 20 mg/dL |
| Urobilinogen | 10 mg/dL |
| pH | 7 |
| Specific gravity | 1.030 |

The following table shows the substances that did interfere with one more of the analytes tested with the DUS 10 test strips. Results are expressed as the lowest concentration of interfering substances that exhibit interference and the resulting change in output of color block:

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| Analyte | Potential Interfering<br>Substance | Concentration at which<br>Interference was<br>observed | Change in<br>color block<br>output |
|------------------|-------------------------------------|--------------------------------------------------------|------------------------------------|
| Urobilinogen | Azo gantrinsin<br>(Sulfamethoxazol) | ≥105mg/dL | +1 |
| | Bilirubin | ≥4mg/dL | +1 |
| | Formaldehyde | ≥150mg/dL | -1 |
| | Nitrofurantoin | ≥40mg/dL | +1 |
| | p-Amino salicylic acid | ≥750mg/dL | +1 |
| | Phenazopyridine | ≥37mg/dL | +1 |
| | Riboflavin | ≥25mg/dL | +1 |
| | Selenium | ≥220mg/dL | +1 |
| Glucose | Ascorbic Acid | ≥40mg/dL | -1 |
| | Bilirubin | ≥6mg/dL | +1 |
| | Chlorine Bleach | ≥1% | +1 |
| | Formaldehyde | ≥150mg/dL | +1 |
| | Lithium | ≥40mg/dL | -1 |
| | NaCl (Specific gravity) | ≤1.000 | +1 |
| Bilirubin | Ascorbic Acid | ≥40mg/dL | -1 |
| | p-Amino salicylic acid | ≥1500mg/dL | +1 |
| | Phenazopyridine | ≥37mg/dL | +1 |
| | Selenium | ≥220mg/dL | +1 |
| Ketones | Bilirubin | ≥4mg/dL | +1 |
| | Captopril | ≥150mg/dL | +1 |
| | NaCl (Specific gravity) | ≥1.040 | +1 |
| Blood | Albumin | ≥1000mg/dL | -1 |
| | Ascorbic Acid | ≥30mg/dL | -1 |
| | Bilirubin | ≥6mg/dL | +1 |
| | Captopril | ≥150mg/dL | -1 |
| | Chlorine Bleach | ≥0.5% | +1 |
| | Formaldehyde | ≥150mg/dL | +1 |
| | NaCl (Specific gravity) | ≥1.040 | -1 |
| | Nitrofurantoin | ≥30mg/dL | +1 |
| | Riboflavin | ≥50mg/dL | +1 |
| | Urobilinogen | ≥20mg/dL | -1 |
| pH | - | - | - |
| Specific Gravity | pH | >8 | +1 |
| | | | |
| Protein | Acetaminophen | 50mg/dL | +1 |
| | Bilirubin | ≥6mg/dL | +1 |
| | Hemoglobin | ≥5mg/dL | +1 |
| | Nitrofurantoin | ≥20mg/dL | +1 |
| | Riboflavin | ≥25mg/dL | -1 |
| | Urobilinogen | ≥20mg/dL | -1 |
| | pH | ≥9 | +1 |
| Nitrite | Ascorbic Acid | ≥40mg/dL | -1 |
| | Bilirubin | ≥4mg/dL | +1 |
| | Nitrofurantoin | ≥20mg/dL | +1 |
| | Phenazopyridine | ≥37mg/dL | +1 |
| | Riboflavin | ≥50mg/dL | +1 |
| | Selenium | ≥300mg/dL | +1 |
| | Urobilinogen | ≥15mg/dL | +1 |
| Leukocytes | Albumin | ≥1000mg/dL | -1 |
| | Bilirubin | ≥4mg/dL | +1 |
| | Captopril | ≥150mg/dL | -1 |
| | Chlorine Bleach | ≥0.5% | +1 |
| | Formaldehyde | ≥150mg/dL | +1 |
| | NaCl (Specific gravity) | ≥1.040 | -1 |
| | Nitrofurantoin | ≥30mg/dL | +1 |
| | Oxalic Acid | ≥45mg/dL | -1 |
| | Glucose | ≥1500mg/dL | -1 |
| | Phenazopyridine | ≥50mg/dL | +1 |
| | Riboflavin | ≥37mg/dL | +1 |
| | Selenium | ≥300mg/dL | +1 |
| | Tetracycline | ≥40mg/dL | -1 |
| | Urobilinogen | >15mg/dL | +1 |

{13}------------------------------------------------

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#### The labeling includes the following limitations to address the interferences observed:

As with all laboratory tests, definitive diagnostic or therapeutic decisions should not be based on any single result of method. Substances that cause abnormal urine color may affect the readability of test pads in urinalysis reagent strips.

Urinary ascorbic acid concentrations as low as 40mg/dl can cause interference in specimens with low concentrations of glucose, blood, nitrite and bilirubin

Urobilinogen: The absence of urobilinogen in the specimen cannot be determined. The test area will react with interfering substances known to react with Ehrlich's reagent, such as paminosalicylic acid. Drugs containing azo gantrisin (sulfamethoxazol) or high bilirubin may give a masking golden color. Preservative formaldehyde may cause false negatives. The test is not reliable method for the detection of porphobilinogen.

Glucose: Ascorbic acid (>40 mg/dL) may cause false negative results at low levels (100 mg/dL) of glucose. Ketones reduce the sensitivity of the test. Moderately high ketone levels (≥40 mg/dL) may cause false negatives for specimens containing a small amount of glucose (100 mg/dL). Chlorine Bleach (≥1%), low SG (≤1.000) and formaldehyde (≥150 mg/dL) may cause false positive results.

Bilirubin: Metabolites of drugs, such as selenium(≥220 mg/dL) or phenazopyridine(≥37 mg/dL) may cause false positives. p-Amino salicylic acid(≥1500 mg/dL) can produce a yellow-orange to red color response, which may lead to false positive bilirubin readings. Ascorbic acid (≥40 mg/dL) may cause false negatives.

Ketones: Low level false positive reactions may be seen in highly concentrated urine specimens (SG>1.004) or in specimens containing large amounts of levodopa drug metabolites such as captopril. The uroprotective drug mesna (sodium 2-mercaptoethane sulfonate) and other free-sulfhydryl compounds produce false-positive results in ketone methods that are based on the Legal reaction (alkaline sodium nitroprusside).

pH: If excessive urine remains on the strip because of improper test procedure, it is possible that the acidic buffer in the protein pad comes out and affects the neighboring pH pad, decreasing the measured pH. This phenomenon is called "run-over effect."

Blood: Elevated specific gravity (≥1.040) or protein in urine (≥1000 mg/dL) may reduce the sensitivity of the blood test pad leading to lower results. Microbial peroxidase associated with urinary tract infections may cause false positive results. Ascorbic acid concentrations (>30 mg/dl) may cause false negatives at trace levels of blood. Substances that cause abnormal urine color, such as drugs containing azo dyes, nitrofurantoin and riboflavin may cause false positive result. Strong oxidizing cleaning agents such as chlorine bleach cause false positive results.

Specific Gravity (SG): Alkaline urine (pH≥8) may cause false positive results.

Protein: False positive results may be found in strongly basic urine (pH>9). Protein testing should not be performed using turbid urine specimens. Metabolites of drugs such as acetaminophen may cause false positives. Hemoglobin may also cause false positives.

{15}------------------------------------------------

Pigments such as bilirubin and azo-containing compounds cause false positive results.

Nitrite: Ascorbic acid (≥40mg/dL) may cause false negative results with urine containing low levels of nitrite (<0.05mg/dL). The negative result does not always mean that the patient is free from bacteriuria. Pink spots or pink edges should not be interpreted as positive results. Medications such as phenazopyridine or other azo-containing compounds or other dyes cause false positive results.

Leukocvte: The test results may not always be consistent with the leukocyte cell number by the microscopic examination. Strong oxidizing agents such as chlorine bleach (≥0.5%) and formaldehyde (≥150 mg/dL) may cause false positive results. Falsely low results may be seen with elevated glucose (≥1500 mg/dL), high SG (≥1.040), oxalic acid (≥45 mg/dL) and high level of albumin (≥1000 mg/dL). Drugs causing decreased or false negative results include tetracycline, captopril. Substance that color urine, such as a nitrofurantoin. riboflavin, selenium and bilirubin, may cause false positive results.

## 2. Method Comparison study

The method comparison study was conducted at three clinical sites with a total of867 samples. Three medical technicians performed the testing at each site. Fresh urine samples were obtained at each medical facility and the samples were processed within 4 hours. The results from the DUS 10 test strips were compared to the predicate device (Multistix 10SG). The results of the method comparison study for the combines sites are shown in the tables below:

| URO (Total) | Predicate device (mg/mL) | | | | |
|-----------------------|--------------------------|------|------|------|------|
| New device<br>(mg/mL) | Norm | 1 | 2 | 4 | 8 |
| 8 | | | | 5 | 39 |
| 4 | | | 4 | 83 | 2 |
| 2 | | 4 | 112 | 2 | |
| 1 | | 80 | 1 | | |
| Norm | 535 | | | | |
| Total | 535 | 84 | 117 | 90 | 41 |
| Exact agreement | 100% | 95% | 96% | 92% | 95% |
| Within 1 block | 100% | 100% | 100% | 100% | 100% |

Results for urinary urobilinogen (URO):

{16}------------------------------------------------

Results for urinary glucose (GLU):

| GLU (Total) | Predicate device (mg/mL) | | | | | |
|-----------------------|--------------------------|------|------|------|------|------|
| New device<br>(mg/mL) | Neg | 100 | 250 | 500 | 1000 | 2000 |
| 2000 | | | | | 1 | 23 |
| 1000 | | | | 2 | 38 | 1 |
| 500 | | | 2 | 58 | 2 | |
| 250 | | 2 | 70 | 3 | | |
| 100 | | 70 | 1 | | | |
| Neg | 594 | | | | | |
| Total | 594 | 72 | 73 | 63 | 41 | 24 |
| Exact agreement | 100% | 97% | 96% | 92% | 93% | 96% |
| Within 1 block | 100% | 100% | 100% | 100% | 100% | 100% |

Results for urinary Bilirubin (BIL):

| BIL (Total) | Predicate device (mg/mL) | | | | |
|-----------------|--------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------|------|--|
| New device | Neg | 1 | 2 | ব | |
| (mg/mL) | | | | | |
| ব | | | 3 | 44 | |
| 2 | | ব | 83 | 3 | |
| 1 | | 82 | ব | | |
| Neg | 644 | | | | |
| | | | | | |
| Total | 644 | 86 | 90 | 47 | |
| Exact agreement | 100% | તે તે જ જીરી તેમ જ દૂધની ડેરી જેવી સવલતો પ્રાપ્ય થયેલી છે. આ ગામનાં પ્રાથમિક શાળા, પંચાયતઘર, આંગણવાડી તેમ જ દૂધની ડેરી જેવી સવલતો પ્રાપ્ય થયેલી છે. આ ગામનાં લોકોનો મુખ્ય વ્ય | 92% | 94% | |
| Within 1 block | 100% | 100% | 100% | 100% | |

Results for urinary Ketones (KET):

| KET (Total) | Predicate device (mg/mL) | | | | | |
|-----------------------|--------------------------|------|------|------|------|------|
| New device<br>(mg/mL) | Neg | 5 | 15 | 40 | 80 | 160 |
| 160 | | | | | | 9 |
| 80 | | | | 4 | 37 | |
| 40 | | | | 59 | 2 | |
| 15 | | 2 | 85 | | | |
| 5 | | 58 | 8 | | | |
| Neg | 602 | | | | | |
| Total | 602 | 60 | 93 | 63 | 39 | 9 |
| Exact agreement | 100% | 97% | 91% | 94% | 95% | 100% |
| Within 1 block | 100% | 100% | 100% | 100% | 100% | 100% |

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Results for urinary Blood (BLD):

| BLD (Total) | Predicate device (mg/mL) | | | | |
|--------------------|--------------------------|------|------|------|------|
| New device (mg/mL) | Neg | 10 | 25 | 80 | 200 |
| 200 | | | | 8 | 153 |
| 480 | | | 8 | 146 | 7 |
| 225 | | 9 | 141 | 5 | |
| 10 | | 157 | 5 | | |
| Neg | 228 | | | | |
| Total | 228 | 166 | 154 | 159 | 160 |
| Exact agreement | 100% | 95% | 92% | 92% | 96% |
| Within 1 block | 100% | 100% | 100% | 100% | 100% |

Results for urinary Protein (PRO):

| PRO (Total) | Predicate device (mg/mL) | | | | | |
|--------------------|--------------------------|------|------|------|------|------|
| New device (mg/mL) | Neg | 15 | 30 | 100 | 300 | 1000 |
| 1000 | | | | | 2 | 16 |
| 300 | | | | 5 | 49 | 1 |
| 100 | | | 6 | 101 | 1 | |
| 30 | | 2 | 125 | 3 | | |
| 15 | | 125 | 2 | | | |
| Neg | 419 | | | | | |
| Total | 419 | 137 | 133 | 109 | 52 | 17 |
| Exact agreement | 100% | 91% | 94% | 93% | 94% | 94% |
| Within 1 block | 100% | 100% | 100% | 100% | 100% | 100% |

Results for urinary Nitrite (NIT):

| NIT (Total) | Predicate device (mg/mL) | | |
|--------------------|--------------------------|-------|------|
| New device (mg/mL) | Neg | Trace | Pos |
| Pos | | 4 | 309 |
| Trace | | 121 | 6 |
| Neg | 427 | | |
| Total | 427 | 125 | 315 |
| Exact agreement | 100% | 97% | 98% |
| Within 1 block | 100% | 100% | 100% |

{18}------------------------------------------------

| LEU (Total) | Predicate device (mg/mL) | | | | |
|-----------------------|--------------------------|------|------|------|------|
| New device<br>(mg/mL) | Neg | 15 | 70 | 125 | 500 |
| 500 | | | | 4 | 106 |
| 125 | | | 5 | 131 | 8 |
| 70 | | 6 | 119 | 6 | |
| 15 | | 100 | 3 | | |
| Neg | 379 | | | | |
| Total | 379 | 106 | 127 | 141 | 114 |
| Exact agreement | 100% | 94% | 94% | 93% | 93% |
| Within 1 block | 100% | 100% | 100% | 100% | 100% |

Results for urinary Leukocytes (LEU):

Results for urinary pH (pH):

| pH (Total) | Predicate device (mg/mL) | | | | | | |
|-----------------------|--------------------------|------|------|------|------|------|------|
| New device<br>(mg/mL) | 5 | 6 | 6.5 | 7 | 7.5 | 8 | 8.5 |
| 8.5 | | | | | | 5 | 39 |
| 8 | | | | | 5 | 102 | 3 |
| 7.5 | | | | 9 | 106 | 4 | |
| 7 | | | 6 | 148 | 5 | | |
| 6.5 | | 8 | 176 | 3 | | | |
| 6 | 3 | 140 | 10 | | | | |
| 5 | 89 | 6 | | | | | |
| Total | 92 | 154 | 192 | 160 | 116 | 111 | 42 |
| Exact<br>agreement | 97% | 91% | 92% | 93% | 91% | 92% | 93% |
| Within 1 block | 100% | 100% | 100% | 100% | 100% | 100% | 100% |

{19}------------------------------------------------

| SG (Total) | Predicate device (mg/mL) | | | | | | |
|-----------------------|--------------------------|-------|-------|-------|-------|-------|-------|
| New device<br>(mg/mL) | 1.000 | 1.005 | 1.010 | 1.015 | 1.020 | 1.025 | 1.030 |
| 1.030 | | | | | | 6 | 77 |
| 1.025 | | | | | 6 | 105 | 5 |
| 1.020 | | | | 9 | 166 | 3 | |
| 1.015 | | | 7 | 161 | 7 | | |
| 1.010 | | 9 | 144 | 7 | | | |
| 1.005 | 1 | 100 | 5 | | | | |
| 1.000 | 49 | 0 | | | | | |
| Total | 50 | 109 | 156 | 177 | 179 | 114 | 82 |
| Exact agreement | 98% | 92% | 92% | 91% | 93% | 92% | 94% |
| Within 1 block | 100% | 100% | 100% | 100% | 100% | 100% | 100% |

Results for urinary Specific Gravity (SG):

#### Expected values/Reference range:

Urobilinogen: The normal urobilinogen range is 0.1 to 1.0 Ehrlich unit /dl. If results exceed the concentration of 2.0 mg/d1, the patient and the urine specimen should be evaluated further.

Glucose: The kidney normally excretes small amounts of glucose. Concentrations of 100mg/dl may be considered as abnormal if found consistently.

Bilirubin: Normally no bilirubin is detectable in urine by even the most sensitive methods. Even trace amounts of bilirubin are sufficiently abnormal to require further investigation.

Ketones: Ketone bodies should not be detected in normal urine specimens with this reagent.

pH: Urine values generally range from pH 4.5 - 8.

Blood: Normally, no hemoglobin is detectable in urine. When hemoglobin appears in urine it may indicate kidney disease or a urinary tract disorder. Blood may often be found in the urine of menstruating females.

Specific Gravity (SG): The normal SG of urine ranges from 1.001 to 1.035.

Protein: Normal urine specimens ordinarily contain some protein (<20mg/dL) therefore only

{20}------------------------------------------------

persistent elevated levels of urine protein indicate kidney or urinary tract disease. The persistent results of trace level or greater indicate significance proteinuria and thus further clinical testing is needed to evaluate the significance of results.

Nitrite: Normally no nitrite is detectable in urine.

Leukocyte: Normally no leukocytes are detectable in urine.

Levey AS, Coresh J, Balk E, et al. National Kidney Foundation practice guidelines for chronic kidney disease: evaluation, classification, stratification. Ann Intern Med. 139:137-147; 2003

#### Conclusion

The new device (DUS 2GP Reagent Strips, DUS 5 Reagent Strips, DUS 10 Reagent Strips) has the same device characteristics as the predicate device. The results of the testing show that the new device is substantially equivalent to the predicate device.