UC-1800 Automatic Urine Analyzer, URIT 11FA Urine Reagent Strips, URIT 12FA Urine Reagent Strips
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 |
Indications for 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)
Related Devices
- K042421 — URITEK 151 URINE ANALYZER, MODEL TC-151 · Teco Diagnostics · May 9, 2005
- K101852 — CHEM VELOCITY AUTOMATED URINE CHEMISTRY SYSTEM, STRIPS AND CALCHEK KIT · Iris International Inc., A Division of Iris Iris I · Mar 23, 2011
Submission Summary (Full Text)
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FDA
U.S. FOOD & DRUG
ADMINISTRATION
# 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY
ASSAY AND INSTRUMENT
## I Background Information:
A 510(k) Number
K232317
B Applicant
URIT Medical Electronic Co., Ltd.
C Proprietary and Established Names
UC-1800 Automatic Urine Analyzer, URIT 11FA Urine Reagent Strips, URIT 12FA Urine Reagent Strips
D Regulatory Information
| Product Code(s) | Classification | Regulation Section | Panel |
| --- | --- | --- | --- |
| JIO | Class II | 21 CFR 864.6550 - Occult blood test | HE - Hematology |
| JIL | Class II | 21 CFR 862.1340 - Urinary Glucose (Nonquantitative) Test System | CH - Clinical Chemistry |
| JFY | Class II | 21 CFR 862.1225 - Creatinine test system | CH - Clinical Chemistry |
| CDM | Class I | 21 CFR 862.1785 - Urinary urobilinogen (nonquantitative) test system | CH - Clinical Chemistry |
| CEN | Class I | 21 CFR 862.1550 - Urinary pH (nonquantitative) test system | CH - Clinical Chemistry |
| JIN | Class I | 21 CFR 862.1435 - Ketones | CH - Clinical Chemistry |
Food and Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993-0002
www.fda.gov
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| Product Code(s) | Classification | Regulation Section | Panel |
| --- | --- | --- | --- |
| | | (nonquantitative) test system | |
| JJB | Class I | 21 CFR 862.1115 - Urinary bilirubin and its conjugates (nonquantitative) test system | CH - Clinical Chemistry |
| JMT | Class I | 21 CFR 862.1510 - Nitrite (nonquantitative) test system | CH - Clinical Chemistry |
| LJX | Class I | 21 CFR 864.7675 - Leukocyte peroxidase test | HE - Hematology |
| JRE | Class I | 21 CFR 862.2800 - Refractometer for clinical use | CH - Clinical Chemistry |
| JMA | Class I | 21 CFR 862.1095 - Ascorbic acid test system | CH - Clinical Chemistry |
| JIR | Class I | 21 CFR 862.1645 - Urinary protein or albumin (nonquantitative) test system | CH - Clinical Chemistry |
| KQO | Class I | 21 CFR 862.2900 - Automated urinalysis system | CH - Clinical Chemistry |
## II Submission/Device Overview:
### A Purpose for Submission:
New device
### B Measurand:
Measurement of the following in urine samples: ascorbic acid, microalbumin, leukocytes, creatinine, ketone, urobilinogen, bilirubin, glucose, protein, specific gravity, blood, pH, nitrite, color and turbidity.
K232317 - Page 2 of 33
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C Type of Test:
Qualitative and semi-quantitative urinalysis
III Intended Use/Indications for Use:
A Intended Use(s):
See Indications for Use below.
B Indication(s) for 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.
C Special Conditions for Use Statement(s):
Rx - For Prescription Use Only
URIT 11FA and 12FA Urine Reagent Strips are not to be read visually
The UC-1800 Automatic Urine Analyzer is for clinical laboratory use only, not for point-of-care use
D Special Instrument Requirements:
The UC-1800 Automatic Urine Analyzer
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## IV Device/System Characteristics:
### A Device Description:
The UC-1800 Automatic Urine Analyzer is used together with the URIT 11FA and the URIT 12 FA test strips for semi-quantitative or qualitative detection of 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.
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. 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. Measured results are printed through either the built-in printer or an external printer.
### B Principle of Operation:
**Test strip measurement principle**
The strips are used to determine the components to be measured in urine by dry chemistry methods together with the urine analyzer. Various components to be tested in 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. Measurement of test strips is conducted by the analyzer using the reflective photoelectric colorimetry method using CIS (contact image sensor) image scanning analysis technology for detection.
**URIT 11FA and 12FA Urine Reagent Strips**
**Ascorbic Acid (URIT 11FA only):** Based on the principle of Tillman’s Reagent, Ascorbic acid can reduce the dye from blue to red.
**Nitrite:** In this reaction, nitrate is reduced to nitrite by Gram-negative bacteria in the urine, the nitrite will react with arsenilic acid to form a diazonium compound, and the diazonium compound will be combined with naphthyl ethylenediamine dihydrochloride to show a pink color.
**Microalbumin:** Based on the dye-binding method, microalbumin can react with the dye to form a pink complex and produce a color change.
**Leukocytes:** Based on the 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.
**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.
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Ketone: Based on the principle of sodium nitro prussiate method, sodium nitroprusside can interact with ketone (acetoacetate) under alkaline conditions to become purple. Acetoacetate is particularly sensitive to this.
Urobilinogen: Based on the principle of the azo-binding method, urobilinogen is coupled with diazonium salt under strong acid conditions to form carmine pigment.
Bilirubin: Based on the principle of the azo-coupling method, 2,4-dichloroaniline diazonium salt can react specifically with bilirubin and produce different colors depending on the concentration of bilirubin.
Glucose: Based on the reaction principle of the 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.
Protein: Based on the principle of protein error method of dye binding, the protein can combine with the dye to form a complex that produces a color change. The response to albumin is more sensitive than that of globulin, hemoglobin, Bence-Jones, protein, and mucin.
Blood: Based on the principle of hemoglobin contact activity method, the decomposition of peroxides can be catalyzed through the peroxidase-like action of hemoglobin, thus oxidizing and coloring tetramethylbenzidine.
Specific Gravity: The test uses the polyelectrolyte method 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.
pH: The pH value within the range from 5.0 to 9.0 is measured by a Ph indicator.
UC-1800 Automatic Urine Analyzer
Measurement of test strips is performed by the reflectance photometry method. During the measurement, the reacted pads on strip (the 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 amount of reflective light from each reacted pad with the reflective light of the calibration pad. The concentrations of analytes 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 shines on the reacted pads and the calibration pad on the strip. The absorbed and reflected light amounts vary with the color of the reagent pads. If the color is darker, more light is absorbed, and less light is reflected, and vice versa. (i.e., the degree of color development is proportional to the concentration of analyzes in urine).
Turbidity measurement principle: The turbidity module emits light through the sample and then detects how much light is scattered by the particles in the water at a $90^{\circ}$ angle to the incident light.
Color measurement principle: The urine color can be detected by the professional color recognition sensor (filter).
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C Instrument Description Information:
1. Instrument Name:
UC-1800 Automatic Urine Analyzer
2. Specimen Identification:
Urine identification can be performed manually or with analyzer barcode reader.
3. Specimen Sampling and Handling:
The UC-1800 Automatic Urine Analyzer is characterized by fully automated operation. Samples can be labeled with a barcode, which is read with a barcode reader. The instrument automatically performs a series of operations: sample transmitting, sample aspirating, sample dropping, rinsing, strip sorting, strip feeding, color identifying, and measurement. Specimen handling recommendations are provided in the labeling.
4. Calibration:
It is recommended to use the URIT specific gravity, turbidity, and color calibration products to calibrate the physical module every 4 weeks. A white calibration strip is used to check the remittance outputs of the LEDs in the read head. Labeling recommends that the user perform calibration verification with the white strip after maintenance, with a new lot of strips, with a new bottle of strips, when changing operators, or when questioning results.
5. Quality Control:
Urinalysis controls are intended for the urine analyzer and matched urine reagent strips to monitor the quality of the urinalysis test. The following quality controls are recommended:
Urinalysis Control NO.I: Negative control
Urinalysis Control NO.II: Positive control
Urinalysis Control NO.III: Positive control for Ascorbic Acid only
Quality Control Solution TUR for turbidity
Quality Control Solution COL for color
V Substantial Equivalence Information:
A Predicate Device Name(s):
Uritest 50 Urine Analyzer, Uritest -500B Urine Analyzer, Uritest 10G Urine Reagent Strips, Uritest 11G Urine Reagent Strips
B Predicate 510(k) Number(s):
K082811
K232317 - Page 6 of 33
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C Comparison with Predicate(s):
| Device & Predicate Device(s): | K232317 | K082811 |
| --- | --- | --- |
| Device Trade Name | UC-1800 Automatic Urine Analyzer, URIT 11FA Urine Reagent Strips, URIT 12FA Urine Reagent Strips | Uritest-50 Urine Analyzer, Uritest-500B Urine Analyzer, Uritest 10G Urine Reagent Strips, Uritest 11G Urine Reagent Strips |
| General Device Characteristic Similarities | | |
| Intended Use/Indications For Use | Semi-quantitative tests for ascorbic acid, leukocytes, ketone, urobilinogen, bilirubin, glucose, protein, specific gravity, blood and pH in urine | Same |
| Specimen Type | Human Urine | Same |
| Sampling Format | Strips | Same |
| Specimen ID enter | Manually enter or by bar code reader | Same |
| Analytes and Measuring Ranges | Ascorbic acid, Nitrite, Leukocyte, Ketone, Urobilinogen, Bilirubin, Glucose, Protein, Blood, Specific Gravity, PH | Same |
| Prescription Use | For prescription use only | Same |
| General Device Characteristic Differences | | |
| Analytes | Microalbumin and Creatinine | N/A |
VI Standards/Guidance Documents Referenced:
CLSI EP06 2nd Edition: Evaluation of Linearity of Quantitative Measurement Procedures
CLSI EP07 3rd Edition: Interference Testing in Clinical Chemistry
CLSI EP09c 3rd Edition: Measurement Procedure Comparison and Bias Estimation Using Patient Samples
K232317 - Page 7 of 33
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CLSI EP17-A2: Evaluation of Detection Capability for Clinical Laboratory Measurement Procedures
IEC 61010-1 Edition 3.1 2017-01: Consolidated Version: Safety requirements for electrical equipment for measurement, control, and laboratory use - Part 1: General requirements
IEC 61326-2-6 Edition 3.0 2020-10: Electrical equipment for measurement control and laboratory use - EMC requirements - Part 2-6: Particular requirements - In vitro diagnostic (IVD) medical equipment
IEC 61326-1 Edition 3.0 2020-10: Electrical equipment for measurement control and laboratory use - EMC requirements - Part 1: General requirements
IEC 60601-1 Edition 3.2 2020-08 Consolidated version: Medical electrical equipment – Part 1: General requirements for basic safety and essential performance
## VII Performance Characteristics (if/when applicable):
## A Analytical Performance:
1. Precision/Reproducibility:
The Repeatability (With-in Run) Precision of the candidate device was evaluated using negative human urine samples and spiked urine samples for each analyte. Each sample was tested in 20 replicates across 3 instruments with the 3 lots of URIT 11FA Urine Reagent Strips and 3 lots of URIT 12FA Urine Reagent Strips (one lot of URIT 11FA and one lot of URIT 12FA test strips each instrument) for a total of 60 measurements at each concentration. The representative results are summarized in the tables below.
Summary of Repeatability (Within Run) Precision
| 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) | |
| Nitrite | -(Negative) | +(Positive) | | | | |
| Exact agreement | 100% (60/60) | 100% (60/60) | | | | |
| ± 1 color block | 100% (60/60) | 100% (60/60) | | | | |
| 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) | |
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| Test | Expected Value | | | | | |
| --- | --- | --- | --- | --- | --- | --- |
| ± 1 color block | 100%
(60/60) | 100%
(60/60) | 100%
(60/60) | 100%
(60/60) | 100%
(60/60) | |
| 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) | |
| 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) | |
| 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) | |
| 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) |
| 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) | |
| 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) |
| 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) | |
| 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) |
| pH | 8.0 | 8.5 | 9.0 | | | |
| Exact agreement | 100%
(60/60) | 100%
(60/60) | 100%
(60/60) | | | |
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Summary of Repeatability (Within Run) Precision for Turbidity and Color
| 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) | | | |
| | | | | | | | |
| Color | Colorless | Brown | Yellow | Red | Green | Orange | Blue |
| Exact agreement | 100% (60/60) | 100% (60/60) | 100% (60/60) | 100% (60/60) | 100% (60/60) | 100% (60/60) | 100% (60/60) |
The Reproducibility (Between-Run) Precision of the candidate device was evaluated by using negative human urine samples and spiked urine samples for each analyte. Each sample was tested for 20 days with 2 runs per day, 1 replicate per run using 3 lots of URIT 11FA Urine Reagent Strips and 3 lots of URIT 12FA Urine Reagent Strips on 3 instruments (one lot of URIT 11FA and one lot of URIT 12FA test strips each instrument) in 3 sites (one instrument per site) for a total of 120 measurements at each concentration. The representative results are summarized in the tables below.
Summary of Reproducibility (Between-Run) Precision
| 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) | | | |
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| Test | Expected Value | | | | | |
| --- | --- | --- | --- | --- | --- | --- |
| Nitrite | - (Negative) | + (Positive) | | | | |
| Exact agreement | 100% (120/120) | 100% (120/120) | | | | |
| ± 1 color block | 100% (120/120) | 100% (120/120) | | | | |
| 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) | |
| 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) | |
| 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) | |
| 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) | |
| 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) |
| Test | Expected Value | | | | | |
| 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) | |
| 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) |
| Blood (CELL/μL) | -(0) | +-(10) | +1(25) | +2(80) | +3(200) | |
{11}
| Test | Expected Value | | | | | |
| --- | --- | --- | --- | --- | --- | --- |
| 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) | |
| 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) |
| ± 1 color block | 100% (120/120) | 100% (120/120) | 100% (120/120) | 100% (120/120) | 100% (120/120) | 100% (120/120) |
| 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) | | | |
| 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) | | |
| 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) | |
Summary of Repeatability (Between-Run) Precision for Turbidity and Color
| 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) | | | | |
| | | | | | | | | |
| Color | Colorless | Brown | Yellow | Red | Green | Orange | Blue | Purple |
| Exact agreement | 100% (120/120) | 100% (120/120) | 100% (120/120) | 100% (120/120) | 100% (120/120) | 100% (120/120) | 100% (120/120) | 100% (120/120) |
2. Linearity:
A study was conducted to evaluate the assay reportable range for each analyte of the candidate device. The assay reportable range was evaluated by measuring samples containing known concentrations of all measurement blocks of all analytes. The results are summarized in the tables below.
K232317 - Page 12 of 33
{12}
Summary of Linearity of URIT 11/12FA Urine Reagent Strips - Common Analytes
| Analyte | Qualitative Rank | Semi-Quantitative Rank | Concentration/Level Tested | Agreement at same block |
| --- | --- | --- | --- | --- |
| Leukocyte | - | 0 | 0 leu/mcL | 100% (63/63) |
| | +/- | 15 | 15 leu/mcL | 100% (63/63) |
| | +1 | 70 | 70 leu/mcL | 100% (63/63) |
| | +2 | 125 | 125 leu/mcL | 100% (63/63) |
| | +3 | 500 | 500 leu/mcL | 100% (63/63) |
| Ketones | - | 0 | 0 mg/dL | 100% (63/63) |
| | +/- | 5 | 5 mg/dL | 100% (63/63) |
| | +1 | 15 | 15 mg/dL | 100% (63/63) |
| | +2 | 40 | 40 mg/dL | 100% (63/63) |
| | +3 | 80 | 80 mg/dL | 100% (63/63) |
| Urobilinogen | Normal | Normal | Normal | 100% (63/63) |
| | +1 | 2.0 | 2.0 mg/dL | 100% (63/63) |
| | +2 | 4.0 | 4.0 mg/dL | 100% (63/63) |
| | +3 | 8.0 | 8.0 mg/dL | 100% (63/63) |
| Bilirubin | - | 0 | 0 mg/dL | 100% (63/63) |
| | +1 | 0.5 | 0.5 mg/dL | 100% (63/63) |
| | +2 | 2.0 | 2.0 mg/dL | 100% (63/63) |
| | +3 | 6.0 | 6.0 mg/dL | 100% (63/63) |
| Glucose | - | 0 | 0 mg/dL | 100% (63/63) |
| | +/- | 50 | 50 mg/dL | 100% (63/63) |
| | +1 | 100 | 100 mg/dL | 100% (63/63) |
K232317 - Page 13 of 33
{13}
| Analyte | Qualitative Rank | Semi-Quantitative Rank | Concentration/Level Tested | Agreement at same block |
| --- | --- | --- | --- | --- |
| | +2 | 250 | 250 mg/dL | 100% (63/63) |
| | +3 | 500 | 500 mg/dL | 100% (63/63) |
| | +4 | 1000 | 100 mg/dL | 100% (63/63) |
| Protein | - | 0 | 0 mg/dL | 100% (63/63) |
| | +/- | 15 | 15 mg/dL | 100% (63/63) |
| | +1 | 30 | 30 mg/dL | 100% (63/63) |
| | +2 | 100 | 100 mg/dL | 100% (63/63) |
| | +3 | 300 | 300 mg/dL | 100% (63/63) |
| Blood | - | 0 | 0 ery/mcL | 100% (63/63) |
| | +/- | 10 | 10 ery/mcL | 100% (63/63) |
| | +1 | 25 | 25 ery/mcL | 100% (63/63) |
| | +2 | 80 | 80 ery/mcL | 100% (63/63) |
| | +3 | 200 | 200 ery/mcL | 100% (63/63) |
| Specific Gravity | N/A | 1.005 | 1.005 | 100% (63/63) |
| | | 1.010 | 1.010 | 100% (63/63) |
| | | 1.015 | 1.015 | 100% (63/63) |
| | | 1.020 | 1.020 | 100% (63/63) |
| | | 1.025 | 1.025 | 100% (63/63) |
| | | 1.030 | 1.030 | 100% (63/63) |
| pH | N/A | 5.0 | 5.0 | 100% (63/63) |
| | | 5.5 | 5.5 | 100% (63/63) |
| | | 6.0 | 6.0 | 100% (63/63) |
| pH | N/A | 10 | 10 | 100% (63/63) |
| | | 15 | 15 | 100% (63/63) |
| | | 20 | 20 | 100% (63/63) |
| | | 25 | 25 | 100% (63/63) |
| | | 30 | 30 | 100% (63/63) |
K232317 - Page 14 of 33
{14}
| Analyte | Qualitative Rank | Semi-Quantitative Rank | Concentration/Level Tested | Agreement at same block |
| --- | --- | --- | --- | --- |
| | | 6.5 | 6.5 | 100% (63/63) |
| | | 7.0 | 7.0 | 100% (63/63) |
| | | 7.5 | 7.5 | 100% (63/63) |
| | | 8.0 | 8.0 | 100% (63/63) |
| | | 8.5 | 8.5 | 100% (63/63) |
| | | 9.0 | 9.0 | 100% (63/63) |
Summary of URIT 11FA Urine Reagent Strips - Ascorbic acid
| Analyte | Qualitative Rank | Semi-Quantitative Rank | Concentration/Level Tested | Agreement at same block |
| --- | --- | --- | --- | --- |
| Ascorbic acid | - | 0 | 0 mg/dL | 100% (63/63) |
| | +1 | 10 | 10 mg/dL | 100% (63/63) |
| | +2 | 25 | 25 mg/dL | 100% (63/63) |
| | +3 | 50 | 50 mg/dL | 100% (63/63) |
| | +4 | 100 | 100 mg/dL | 100% (63/63) |
Summary of URIT 12FA Urine Reagent Strips - Microalbumin and Creatinine
| Analyte | Semi-Quantitative Rank | Concentration/Level Tested | Agreement at same block |
| --- | --- | --- | --- |
| Microalbumin | 10 | 0 mg/dL | 100% (63/63) |
| | 30 | 10 mg/dL | 100% (63/63) |
| | 80 | 25 mg/dL | 100% (63/63) |
| | 150 | 50 mg/dL | 100% (63/63) |
| Creatinine | 10 | 10 mg/dL | 100% (63/63) |
| | 50 | 50 mg/dL | 100% (63/63) |
| | 100 | 100 mg/dL | 100% (63/63) |
| | 200 | 200 mg/dL | 100% (63/63) |
| | 300 | 300 mg/dL | 100% (63/63) |
The results of the assay reportable range studies support the following measurement ranges for the candidate device:
K232317 - Page 15 of 33
{15}
K232317 - Page 16 of 33
| Analyte | URIT Urine Reagent Strips | |
| --- | --- | --- |
| | 11 FA | 12FA |
| Ascorbic acid | 0, 10, 25, 50, 100 mg/dL | N/A |
| | -, +/-, +1, +2, +3 | |
| Microalbumin | N/A | 10, 30, 80, 150 mg/L |
| Leukocytes | 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 | |
| Bilirubin | 0, 0.5, 2.0, 6.0 mg/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 | |
3. Analytical Specificity/Interference:
Exogenous and Endogenous Interference
Analytical specificity studies were conducted to evaluate interfering effects of exogenous and endogenous substances on the candidate device. Negative urine samples and low positive samples were spiked with potential interfering substances at various interferent concentrations. Each sample pair (test sample and control sample) was analyzed in replicates of 5 on two UC-1800 Automatic Urine Analyzers with two lots of URIT 11FA and 12FA reagent strips respectively (2 lots of each reagent strip on each analyzer). Results are summarized in the tables below.
The following substances show no interference at tested concentrations:
| Substance | Highest Concentration with No Interference |
| --- | --- |
| Cefoxitin | 1200 mg/dL |
| Ofloxacin | 90 mg/dL |
| Phenazopyridine | 30 mg/dL |
| Salicylic acid | 600 mg/dL |
| Tetracycline | 50 mg/dL |
| Hydroxybutyrate dehydrogenase | 450 mg/dL |
| Protein* | 500 mg/dL |
| Lactose | 10mg/dL |
{16}
| Substance | Highest Concentration with No Interference |
| --- | --- |
| Leukocyte** | 2500leu/uL |
| Potassium chloride | 1500 mg/dL |
| Citric acid | 150 mg/dL |
| Creatine | 10mg/dL |
| Fructose | 100mg/dL |
| Galactose | 80 mg/dL |
| Oxalic acid | 70mg/dL |
| Vitamin B | 10mg/dL |
| Sodium acetate | 2.25mg/dL |
| Sodium chloride | 5500mg/dL |
| Sodium nitrate | 10mg/dL |
| Theophylline | 100 mg/dL |
* This non-interference claim does not apply to protein.
**This non-interference claim does not apply to leukocytes
The following substances that cause interference are listed in the table below.
| Analyte | Substance | Concentration limit with no significant interference (mg/dL) | Interference concentration (mg/dL) | Effect when above the concentration limit |
| --- | --- | --- | --- | --- |
| Leukocyte | Urobilinogen | 25 | 50 | From - to +- (False Positive) |
| | | | 75 | From +- to 1 (Elevated Positive Result) |
| | | | 150 | From +- to 2 (Elevated Positive Result) |
| | | | 150 | From - to 1 (False Positive) |
| | Amoxicillin | 700 | 1050 | From +- to - (False Negative) |
| | Ibuprofen | 125 | 187.5 | From +- to - (False Negative) |
| | Methylamine + Methylene Blue | 200 + 35 | 300 + 52.5 | From - to +- (False Positive) |
| | | 200 + 35 | 300 + 52.5 | From +- to 1 (Elevated Positive Result) |
| | Bilirubin | 60 | 80 | From - to +- (False Positive) |
| | Glucose | 1500 | 1666.7 | From +- to - (False Negative) |
| Ketones | Sodium Bicarbonate | 375 | 750 | From +- to - (False Negative) |
| | Glycine | 225 | 337.5 | From +- to - (False Negative) |
| | Sodium Phosphate | 250 | 375 | From +- to - (False Negative) |
| | Methyldopa | 50 | 100 | From - to +- (False Positive) |
| | | | 150 | From +- to 1 (Elevated Positive Result) |
| | Methylamine + Methylene Blue | 100 + 17.5 | 200 + 35 | From +- to - (False Negative) |
K232317 - Page 17 of 33
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K232317 - Page 18 of 33
| Analyte | Substance | Concentration limit with no significant interference (mg/dL) | Interference concentration (mg/dL) | Effect when above the concentration limit |
| --- | --- | --- | --- | --- |
| | Acetylcysteine | 3.3 | 5 | From - to +- (False Positive) |
| Ammonium Chloride | 1250 | 5 | From +- to 1 (Elevated Positive Result) |
| Bilirubin | 60 | 1875 | From +- to - (False Negative) |
| Creatinine | 1125 | 80 | From +- to - (False - (False Negative) |
| Gabapentin | 15 | 1500 | From - to +- (False Positive) |
| Urobilinogen | Methylamine + Methylene Blue | 66.7 + 11.7 | 22.5 | From 1+ to Normal (False Negative) |
| Bilirubin | 40 | 200 + 35 | From Normal to 1+ (False Positive) |
| Nitrite | 0.8 | 100 + 17.5 | From 1+ to 2+ (Elevated Positive Result) |
| Urobilinogen | 12.5 | 60 | From 1+ to 2+ (Elevated Positive Result) |
| Nitrite | 0.8 | 1.7 | From 1+ to Normal (False Negative) |
| Bilirubin | Urobilinogen | 12.5 | 25 | From - to 1+ (False Positive) |
| Ascorbic Acid | 150 | 25 | From 1+ to 2+ (Elevated Positive Result) |
| Methylamine + Methylene Blue | 200 + 35 | 50 | From - to 2+ (False Negative) |
| Nitrite | 5 | 200 | From 1+ to - (False Negative) |
| Lithium Acetoacetate | 80 | 300 + 52.5 | From 1+ to - (False Negative) |
| Peroxide | 5% | 10 | From 1+ to - (False Negative) |
| Glucose | Ascorbic Acid | 50 | 125 | From - to +- (False Positive) |
| Levodopa | 10.8 | 7.50% | From - to +- (False Positive) |
| Methylamine + Methylene Blue | 100 + 17.5 | 100 | From +- to - (False Negative) |
| Bilirubin | 40 | 21.7 | From +- to - (False Negative) |
| Urea | 10,050 | 200 + 35 | From +- to - (False Negative) |
| Protein | Quaternary Ammonium | 50 | 100 | From - to +- (False Positive) |
| | | | 150 | From +- to 1 (Elevated Positive Result) |
{18}
K232317 - Page 19 of 33
| Analyte | Substance | Concentration limit with no significant interference (mg/dL) | Interference concentration (mg/dL) | Effect when above the concentration limit |
| --- | --- | --- | --- | --- |
| | | | | From +- to 2 (Elevated Positive Result) |
| | Sodium Bicarbonate | 750 | 1125 | From +- to 1 (Elevated Positive Result) |
| | Amoxicillin | 700 | 1050 | From +- to - (False Negative) |
| | Gabapentin | 7.5 | 15 | From +- to 1+ (Elevated Positve Reuslt) |
| | Ibuprofen | 62.5 | 125 | From +- to - (False Negative) |
| | Methylamine + Methylene Blue | 66.7 + 11.7 | 100 + 17.5 | From +- to 1+ (Elevated Positive Result) |
| | | | 200 + 35 | From - to +- (False Positive) |
| | Ammonium Chloride | 625 | 1250 | From +- to - (False Negative) |
| | Bilirubin | 40 | 60 | From - to +- (False Positive) |
| | Calcium Chloride | 150 | 225 | From +- to - (False Negative) |
| | Creatinine | 375 | 750 | From +- to 1+ (Elevated Positive Result) |
| | | | 1500 | From - to +-/1+ (False Positive and Elevated Positive Result) |
| | HGB | 1250 | 2500 | From +- to 1+ (Elevated Positive Result) |
| | | | 3750 | From - to +-/1+ (False Positive and Elevated Positive Result) |
| | Urea | 10,050 | 15,025 | From +- to 1+ (Elevated Positive Result) |
| Blood | Peroxidase | 5 | 10 | From - to +- (False Positive) |
| | | | | From +- to 1+ (Elevated Positive Result) |
| | Sodium Bicarbonate | 375 | 750 | From +- to - (False Negative) |
| | Glycine | 112.5 | 225 | From +- to 1+ (Elevated Positive Result) |
| | Ascorbic Acid | 50 | 100 | From +- to - (False Negative) |
| | Biotin | 2500 | 3750 | From - to +- (False Positive) |
| | Furosemide | 50 | 100 | From +- to - (False Negative) |
| | Ibuprofen | 187.5 | 250 | From +- to - (False Negative) |
| | Levodopa | 10.8 | 21.7 | From +- to - (False Negative) |
| | Methyldopa | 16.7 | 33.3 | From - to +- (False Positive) |
| | | | 150 | From +- to 1+ (Elevated Positive Result) |
| | | 66.7 + 11.7 | 100 + 17.5 | From - to +- (False Positive) |
{19}
K232317 - Page 20 of 33
| Analyte | Substance | Concentration limit with no significant interference (mg/dL) | Interference concentration (mg/dL) | Effect when above the concentration limit |
| --- | --- | --- | --- | --- |
| | Methylamine + Methylene Blue | | | From +- to 1+ (Elevated Positive Result) |
| Specific Gravity | Salicylic Acid | 300 | 450 | From 1.010 to 1.020 (Result Rise) |
| | | | 600 | From 1.010 to 1.030 (Result Rise) |
| | Uric Acid | 116.25 | 155 | From 1.015 to 1.025 (Result Rise) |
| | Sodium Bicarbonate | 1125 | 1500 | From 1.020 to 1.005 (Result Reduction) |
| Nitrite | Urobilinogen | 12.5 | 25 | From - to + (False Positive) |
| | Sodium Bicarbonate | 750 | 1125 | From + to - (False Negative) |
| | Ascorbic Acid | 50 | 100 | From + to - (False Negative) |
| | Methylamine + Methylene Blue | 200 + 35 | 300 + 52.5 | From - to + (False Positive) |
| | Bilirubin | 60 | 80 | From + to - (False Negative) |
| | Creatinine | 750 | 1125 | From + to - (False Negative) |
| Ascorbic Acid | Sodium Thiosulfate | 10 | 15 | From - to +- (False Positive) |
| | | | | From +- to 1+ (Elevated Positive Result) |
| | Cysteine | 10 | 15 | From - to +- (False Positive) |
| | | | | From +- to 1+ (Elevated Positive Result) |
| | Sodium Phosphate | 250 | 375 | From +- to 1+ (Elevated Positive Result) |
| | Levodopa | 5.4 | 10.8 | From +- to 1+ (Elevated Positive Result) |
| | Acetylcysteine | 10 | 15 | From +- to 1+ (Elevated Positive Result) |
| | Ammonium Chloride | 1875 | 2500 | From +- to 1+ (Elevated Positive Result) |
| Microalbumin | Quaternary Ammonium | 50 | 100 | From 10 mg/L to 30 mg/L (False Positive) |
| | | | | From 30 mg/L to 80 mg/L (Elevated Positive Result) |
| | Blood | 0.0375% | 0.05% | From 10 mg/L to 30 mg/L (False Positive) |
| | | | | From 30 mg/L to 80 mg/L (Elevated Positive Result) |
{20}
K232317 - Page 21 of 33
| Analyte | Substance | Concentration limit with no significant interference (mg/dL) | Interference concentration (mg/dL) | Effect when above the concentration limit |
| --- | --- | --- | --- | --- |
| | Human IgG | 41.67 | 83.33 | From 10 mg/L to 30 mg/L (False Positive) |
| | | | | From 30 mg/L to 80 mg/L (Elevated Positive Result) |
| | | | 375 | From 10 mg/L to 80 mg/L (False Positive) |
| | | | | From 30 mg/L to 150 mg/L (Elevated Positive Result) |
| | Ascorbic Acid | 200 | 300 | From 30 mg/L to 10 mg/L (False Negative) |
| | Gabapentin | 7.5 | 15 | From 30 mg/L to 80 mg/L (Elevated Positive Result) |
| | | | 30 | From 10 mg/L to 30 mg/L (False Positive) |
| | Methylamine + Methylene Blue | 66.7 + 11.7 | 100 + 17.5 | From 10 mg/L to 30 mg/L (False Positive) |
| | | | 200 + 35 | From 30 mg/L to 80 mg/L (Elevated Positive Result) |
| | Ammonium Chloride | 625 | 1250 | From 30 mg/L to 10 mg/L (False Negative) |
| | Creatinine | 600 | 750 | From 30 mg/L to 80 mg/L (Elevated Positive Result) |
| | | | 1500 | From 10 mg/L to 30 mg/L (False Positive) |
| | HGB | 83 | 208 | From 30 mg/L to 80 mg/L (Elevated Positive Result) |
| | | | 830 | From 10 mg/L to 30 mg/L (False Positive) |
| Creatinine | Acetaminophen | 225 | 300 | From 50 mg/dL to 100 mg/dL (Elevated Positive Result) |
| | Biotin | 830 | 1250 | From 50 mg/dL to 100 mg/dL (Elevated Positive Result) |
| | Furosemide | 100 | 150 | From 50 mg/dL to 100 mg/dL (Elevated Positive Result) |
| | Gabapentin | 15 | 22.5 | From 50 mg/dL to 100 mg/dL (Elevated Positive Result) |
| | Gentamicin Sulphate | 20 | 30 | From 50 mg/dL to 10 mg/dL (False Negative) |
| | Acetylcysteine | 3.3 | 5 | From 50 mg/dL to 100 mg/dL (Elevated Positive Result) |
| | | | 200 | From 10 mg/dL to 50 mg/dL (False Positive) |
{21}
| Analyte | Substance | Concentration limit with no significant interference (mg/dL) | Interference concentration (mg/dL) | Effect when above the concentration limit |
| --- | --- | --- | --- | --- |
| | Ammonium Chloride | 100 | 104.2 | From 50 mg/dL to 10 mg/dL (False Negative) |
To address the interference of levodopa on the test for blood, the following interference limitation is included in the labeling and will be reported in the test report: Levodopa can interfere with the detection of red blood cells leading to a false negative result.
## Interference effect of urine pH
Studies were conducted to assess the effect of urine pH on the test results. For all test strip analytes, except leukocytes and specific gravity, there was no interference from pH across a range of 4.5 to 8.5. Interference effects of urine pH on leukocytes and specific gravity are summarized in the table below.
| Analyte | URIT 11/12 FA Urine Reagent Strips | |
| --- | --- | --- |
| | No interference | Interference condition |
| Leukocytes | pH > 5.5 | pH=4.5, From +- to - (False Negative) |
| Specific Gravity | 5.5-7.5 | pH=4.5, From 1.015 to 1.025 (False Positive) |
| | | pH=4.5, From 1.020 to 1.030 (False Positive) |
| | | pH≥8.5, From 1.015 to 1.005 (False Negative) |
| | | pH≥8.5, From 1.020 to 1.010 (False Negative) |
## Interference effect of urine color
The candidate device includes a correction function for urine colors. The results of the studies demonstrated that the colors red, orange, brown, yellow, green, blue, and purple do not significantly impact the results for the analytes on the URIT 11FA and 12 FA test strips since all results were within +/- 1 color block when testing colored urine for these parameters on the URIT 11FA and 12FA Urine Reagent Strips.
## Interference effect of urine Specific Gravity
Studies were conducted to assess the effect of urine specific gravity on the test results. A negative urine sample was prepared using sodium chloride to adjust the specific gravity to 1.005, 1.010, 1.015, 1.020, 1.025, 1.030, 1.035, 1.040, 1.045, and 1.050, respectively. For all test strip analytes, except leukocytes, there was no interference from specific gravity across a range of 1.005 to 1.050. For leukocytes, false negative results were found at urine specific gravity values higher than 1.040.
K232317 - Page 22 of 33
{22}
| Analyte | URIT 11/12 FA Urine Reagent Strips | |
| --- | --- | --- |
| | No interference | Interference effect |
| Leukocytes | SG < 1.035 | SG ≥1.040, From +- to- (false negative) |
# 4. Assay Reportable Range:
The reportable ranges claimed by the sponsor for the candidate device are summarized in the table below:
| Analyte | URIT Urine Reagent Strips | |
| --- | --- | --- |
| | 11 FA | 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 |
| Leukocytes | 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 | |
| Bilirubin | 0, 0.5, 2.0, 6.0 mg/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 | |
# 5. Traceability, Stability, Expected Values (Controls, Calibrators, or Methods):
Traceability
The sponsor provided information to support the traceability of the candidate device.
# 6. Detection Limit:
Analytical sensitivity
The detection limit study defines the measurement results with analytical sensitivity of $90\%$ as the positive minimum analyte concentration, i.e., the cutoff for switching from negative to
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positive. Each analyte was added to a negative urine sample to prepare five different concentrations. Each concentration was tested on three UC-1800 analyzers with three lots of test strips. Each lot of test strip was tested 20 times on each analyzer. The results are summarized below:
| Analyte | URIT Urine Reagent Strips | |
| --- | --- | --- |
| | 11FA | 12FA |
| Ascorbic acid | 8~10 mg/dL | N/A |
| Nitrite | 0.1-0.2mg/dL | |
| Microalbumin | N/A | 20-30 mg/L |
| Leukocyte | 10~15 leu/mcL | |
| Creatinine | N/A | 25~50 mg/dL |
| Ketone | 4~5 mg/dL | |
| Urobilinogen | 1~2 EU/dL | |
| Bilirubin | 0.4~0.5 mg/dL | |
| Glucose | 40~50 mg/dL | |
| Protein | 10~15 mg/dL | |
| Blood | 5~10 ery/mcL | |
Analytical sensitivity is not applicable for both strips in the detection of pH and Specific Gravity.
## Study 2 – Measurement block cut-off:
A cut-off study was conducted on the candidate device to determine the cut-off concentration between each semi-quantitative block of the reagent strip. The cut-off concentration is defined as the minimum sample concentration at which a test result of $\geq 55\%$ relative to the transition from the block is considered positive. Each testing analyte was added to the negative urine sample to have five concentrations exceeding the expected cut-off concentration. Three lots of URIT 11FA and 12FA urine reagent strips were tested in 20 replicates at each concentration level on three UC-1800 urine analyzers.
The cut-off concentration between each measurement block is summarized in the tables below.
| Glucose | | | |
| --- | --- | --- | --- |
| Block Output | Cut-off, mg/dL | % Positive (11FA Strips) | % Positive (12FA Strips) |
| 100 (1+) | 75 | 86 | 73 |
| 250 (2+) | 165 | 77 | 74 |
| 500 (3+) | 360 | 66 | 76 |
| 1000 (4+) | 735 | 71 | 74 |
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| Blood | | | |
| --- | --- | --- | --- |
| Block Output | Cut-off, ery/μL | % Positive (11FA Strips) | % Positive (12FA Strips) |
| 25 (1+) | 16 | 79 | 77 |
| 80 (2+) | 65 | 77 | 79 |
| 200 (3+) | 130 | 79 | 71 |
| Urobilinogen | | | |
| --- | --- | --- | --- |
| Block Output | Cut-off, EU/dL | % Positive (11FA Strips) | % Positive (12FA Strips) |
| 4 (2+) | 1.8 | 81 | 77 |
| 8 (3+) | 4.5 | 71 | 74 |
| Ketones | | | |
| --- | --- | --- | --- |
| Block Output | Cut-off, mg/dL | % Positive (11FA Strips) | % Positive (12FA Strips) |
| 15 (2+) | 8 | 82 | 74 |
| 40 (3+) | 25 | 82 | 76 |
| 80 (4+) | 63 | 72 | 71 |
| Protein | | | |
| --- | --- | --- | --- |
| Block Output | Cut-off, mg/dL | % Positive (11FA Strips) | % Positive (12FA Strips) |
| 30 (1+) | 21 | 77 | 83 |
| 100 (2+) | 65 | 75 | 70 |
| 300 (3+) | 180 | 79 | 70 |
| Bilirubin | | | |
| --- | --- | --- | --- |
| Block Output | Cut-off, mg/dL | % Positive (11FA Strips) | % Positive (12FA Strips) |
| 2 (2+) | 1.3 | 88 | 78 |
| 6 (3+) | 3 | 79 | 73 |
| Leukocyte | | | |
| --- | --- | --- | --- |
| Block Output | Cut-off, leu/μL | % Positive (11FA Strips) | % Positive (12FA Strips) |
| 70 (1+) | 38 | 92 | 74 |
| 125 (2+) | 88 | 85 | 64 |
| 500 (3+) | 337 | 77 | 69 |
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| pH | | | |
| --- | --- | --- | --- |
| Block Output | Cut-off | % Positive (11FA Strips) | % Positive (12FA Strips) |
| 5.5 | 5.2 | 83 | 73 |
| 6.0 | 5.8 | 86 | 79 |
| 6.5 | 6.3 | 82 | 77 |
| 7.0 | 6.7 | 81 | 78 |
| 7.5 | 7.3 | 76 | 82 |
| 8.0 | 7.8 | 82 | 76 |
| 8.5 | 8.2 | 72 | 94 |
| 9.0 | 8.8 | 68 | 77 |
| Ascorbic Acid | | | |
| --- | --- | --- | --- |
| Block Output | Cut-off, mg/dL | % Positive (11FA Strips) | % Positive (12FA Strips) |
| 25 (1+) | 12 | 76 | N/A |
| 50 (2+) | 32 | 89 | |
| 100 (3+) | 72 | 66 | |
| Creatinine | | | |
| --- | --- | --- | --- |
| Block Output | Cut-off, mg/dL | % Positive (11FA Strips) | % Positive (12FA Strips) |
| 100 | 6.5 | N/A | 77 |
| 200 | 12.5 | | 75 |
| 300 | 21 | | 79 |
| Microalbumin | | | |
| --- | --- | --- | --- |
| Block Output | Cut-off, mg/L | % Positive (11FA Strips) | % Positive (12FA Strips) |
| 80 | 80 | N/A | 88 |
| 150 | 150 | | 79 |
7. Assay Cut-Off:
Not applicable.
8. Accuracy (Instrument):
See Method Comparison.
9. Carry-Over:
The carryover of the candidate device was evaluated by alternately testing high-concentration samples and low-concentration samples, in the sequence of high, low, high, low, high, low, high, low, high and low. For all analytes, all negative/normal samples read as negative/normal, therefore no significant carryover found in the study.
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B Comparison Studies:
1. Method Comparison with Predicate Device:
The accuracy of the test system was assessed by a method comparison study for agreement with comparator devices for each analyte/parameter on candidate device.
A total of 1000 clinical urine samples were tested for the comparison study with the comparator device URITEST-500B Urine Analyzer (K082811), and representative results are summarized in the tables below.
Representative results of URIT 11FA and 12 FA Reagent Strips
| Ascorbic acid (N=1000) (mg/dL) | URIT UC-1800 Automatic Urine Analyzer (11FA test strips) | | | | | |
| --- | --- | --- | --- | --- | --- | --- |
| | | -(0) | +-(10) | +1(25) | +2(50) | +3(100) |
| Predicate device (K082811) Uritest-500B urine analyzer (11G test strip) | -(0) | 716 | 0 | 0 | 0 | 0 |
| | +-(10) | 0 | 95 | 0 | 0 | 0 |
| | +1(25) | 0 | 0 | 98 | 1 | 0 |
| | +2(50) | 0 | 0 | 1 | 40 | 1 |
| | +3(100) | 0 | 0 | 0 | 0 | 48 |
| Total | | 716 | 95 | 99 | 41 | 49 |
| Exact agreement % | | 100% | 100% | 99.00% | 97.60% | 98.00% |
| Agreement ± 1 block % | | 100% | 100% | 100% | 100% | 100% |
| Leukocyte (N=1000) (Leu/mcL) | URIT UC-1800 Automatic Urine Analyzer (11FA test strips) | | | | | |
| --- | --- | --- | --- | --- | --- | --- |
| | | -(0) | +-(15) | +1(70) | +2(125) | +3(500) |
| Predicate device (K082811) Uritest-500B urine analyzer (11G test strip) | -(0) | 532 | 4 | 0 | 0 | 0 |
| | +-(15) | 3 | 205 | 1 | 0 | 0 |
| | +1(70) | 0 | 0 | 107 | 2 | 0 |
| | +2(125) | 0 | 0 | 1 | 69 | 0 |
| | +3(500) | 0 | 0 | 0 | 1 | 75 |
| Total | | 535 | 209 | 109 | 72 | 75 |
| Exact agreement % | | 99.40% | 98.10% | 98.20% | 95.80% | 100% |
| Agreement ± 1 block % | | 100% | 100% | 100% | 100% | 100% |
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| Ketone (N=1000) (mg/dL) | URIT UC-1800 Automatic Urine Analyzer (11FA test strips) | | | | | |
| --- | --- | --- | --- | --- | --- | --- |
| | | -(0) | +-(5) | +1(15) | +2(40) | +3(80) |
| Predicate device (K082811) Uritest-500B urine analyzer (11G test strip) | -(0) | 828 | 0 | 0 | 0 | 0 |
| | +-(5) | 1 | 45 | 1 | 0 | 0 |
| | +1(15) | 0 | 0 | 37 | 1 | 0 |
| | +2(40) | 0 | 0 | 0 | 37 | 1 |
| | +3(80) | 0 | 0 | 0 | 0 | 49 |
| Total | | 829 | 45 | 38 | 38 | 50 |
| Exact agreement % | | 99.90% | 100% | 97.40% | 97.40% | 98.00% |
| Agreement ± 1 block % | | 100% | 100% | 100% | 100% | 100% |
| Nitrite (N=1000) | URIT UC-1800 Automatic Urine Analyzer (11FA test strips) | | |
| --- | --- | --- | --- |
| | | + | - |
| Predicate device (K082811) Uritest-500B urine analyzer (11G test strip) | + | 216 | 3 |
| | - | 3 | 778 |
| Total | | 219 | 781 |
| Complete agreement rate | | 98.60% | 99.60% |
| | | 95% confidence interval | |
| Overall agreement rate OPA | 99.40% | 98.70% | 99.72% |
| Positive percentage agreement rate PPA | 98.63% | 96.05% | 99.53% |
| Negative percentage agreement rate NPA | 99.62% | 98.88% | 99.87% |
| Urobilinogen(N=1000) (EU/dL) | URIT UC-1800 Automatic Urine Analyzer (11FA test strips) | | | | |
| --- | --- | --- | --- | --- | --- |
| | | Normal | +1(2.0) | +2(4.0) | +3(8.0) |
| Predicate device (K082811) Uritest-500B urine analyzer (11G test strip) | Normal | 900 | 1 | 0 | 0 |
| | +1(2.0) | 1 | 42 | 1 | 0 |
| | +2(4.0) | 0 | 0 | 29 | 0 |
| | +3(8.0) | 0 | 0 | 0 | 26 |
| Total | | 901 | 43 | 30 | 26 |
| Exact agreement % | | 99.90% | 97.70% | 96.70% | 100% |
| Agreement ± 1 block % | | 100% | 100% | 100% | 100% |
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| Bilirubin(N=1000) (mg/dL) | URIT UC-1800 Automatic Urine Analyzer (11FA test strips) | | | | |
| --- | --- | --- | --- | --- | --- |
| | | -(0) | +1(0.5) | +2(2.0) | +3(6.0) |
| Predicate device (K082811) Uritest-500B urine analyzer (11G test strip) | -(0) | 931 | 0 | 0 | 0 |
| | +1(0.5) | 1 | 25 | 0 | 0 |
| | +2(2.0) | 0 | 0 | 20 | 0 |
| | +3(6.0) | 0 | 0 | 0 | 23 |
| Total | | 932 | 25 | 20 | 23 |
| Exact agreement % | | 99.90% | 100% | 100% | 100% |
| Agreement ± 1 block % | | 100% | 100% | 100% | 100% |
| Blood (N=1000) (ery/mcL) | URIT UC-1800 Automatic Urine Analyzer (11FA test strips) | | | | | |
| --- | --- | --- | --- | --- | --- | --- |
| | | -(0) | +-(10) | +1(25) | +2(80) | +3(200) |
| Predicate device (K082811) Uritest-500B urine analyzer (11G test strip) | -(0) | 579 | 0 | 0 | 0 | 0 |
| | +-(10) | 0 | 160 | 1 | 0 | 0 |
| | +1(25) | 0 | 2 | 120 | 0 | 0 |
| | +2(80) | 0 | 0 | 0 | 55 | 0 |
| | +3(200) | 0 | 0 | 0 | 0 | 83 |
| Total | | 579 | 162 | 121 | 55 | 83 |
| Exact agreement % | | 100% | 98.80% | 99.20% | 100% | 100% |
| Agreement ± 1 block % | | 100% | 100% | 100% | 100% | 100% |
| Glucose (N=1000) (mg/dL) | URIT UC-1800 Automatic Urine Analyzer (11FA test strips) | | | | | | |
| --- | --- | --- | --- | --- | --- | --- | --- |
| | | -(0) | +-(50) | +1(100) | +2(250) | +3(500) | +3(1000) |
| Predicate device (K082811) Uritest-500B urine analyzer (11G test strip) | -(0) | 810 | 0 | 0 | 0 | 0 | 0 |
| | +-(50) | 1 | 42 | 1 | 0 | 0 | 0 |
| | +1(100) | 0 | 0 | 26 | 0 | 0 | 0 |
| | +2(250) | 0 | 0 | 0 | 19 | 0 | 0 |
| | +3(500) | 0 | 0 | 0 | 0 | 30 | 1 |
| | +3(1000) | 0 | 0 | 0 | 0 | 0 | 70 |
| Total | | 811 | 42 | 27 | 19 | 30 | 71 |
| Exact agreement % | | 99.90% | 100% | 96.30% | 100% | 100% | 98.60% |
| Agreement ± 1 block % | | 100% | 100% | 100% | 100% | 100% | 100% |
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| Protein (N=1000) (mg/dL) | URIT UC-1800 Automatic Urine Analyzer (11FA test strips) | | | | | |
| --- | --- | --- | --- | --- | --- | --- |
| | | -(0) | +-(15) | +1(30) | +2(100) | +3(300) |
| Predicate device (K082811) Uritest-500B urine analyzer (11G test strip) | -(0) | 698 | 1 | 0 | 0 | 0 |
| | +-(15) | 0 | 95 | 1 | 0 | 0 |
| | +1(30) | 0 | 0 | 64 | 0 | 0 |
| | +2(100) | 0 | 0 | 1 | 60 | 1 |
| | +3(300) | 0 | 0 | 0 | 0 | 59 |
| Total | | 698 | 96 | 66 | 60 | 60 |
| Exact agreement % | | 100% | 99.00% | 97.00% | 100% | 98.30% |
| Agreement ± 1 block % | | 100% | 100% | 100% | 100% | 100% |
| PH (N=1000) | URIT UC-1800 Automatic Urine Analyzer (11FA test strips) | | | | | | | | | |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| | | 5.0 | 5.5 | 6.0 | 6.5 | 7.0 | 7.5 | 8.0 | 8.5 | 9.0 |
| Predicate device (K082811) Uritest-500B urine analyzer (11G test strip) | 5.0 | 161 | 2 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| | 5.5 | 0 | 272 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| | 6.0 | 0 | 1 | 212 | 0 | 0 | 0 | 0 | 0 | 0 |
| | 6.5 | 0 | 0 | 1 | 134 | 1 | 0 | 0 | 0 | 0 |
| | 7.0 | 0 | 0 | 0 | 3 | 111 | 0 | 0 | 0 | 0 |
| | 7.5 | 0 | 0 | 0 | 0 | 0 | 48 | 0 | 0 | 0 |
| | 8.0 | 0 | 0 | 0 | 0 | 0 | 0 | 27 | 0 | 0 |
| | 8.5 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 20 | 0 |
| | 9.0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 7 |
| Total | | 161 | 275 | 213 | 137 | 112 | 48 | 27 | 20 | 7 |
| Exact agreement % | | 100% | 98.90% | 99.50% | 97.80% | 99.10% | 100% | 100% | 100% | 100% |
| Agreement ± 1 block % | | 100% | 100% | 100% | 100% | 100% | 100% | 100% | 100% | 100% |
| SG(N=1000) | URIT UC-1800 Automatic Urine Analyzer (11FA test strips) | | | | | | |
| --- | --- | --- | --- | --- | --- | --- | --- |
| | | 1.005 | 1.010 | 1.015 | 1.020 | 1.025 | 1.030 |
| Predicate device (K082811) Uritest-500B urine analyzer (11G test strip) | 1.005 | 33 | 0 | 0 | 0 | 0 | 0 |
| | 1.010 | 0 | 134 | 3 | 0 | 0 | 0 |
| | 1.015 | 0 | 2 | 212 | 0 | 0 | 0 |
| | 1.020 | 0 | 0 | 0 | 273 | 0 | 0 |
| | 1.025 | 0 | 0 | 0 | 1 | 202 | 0 |
| | 1.030 | 0 | 0 | 0 | 0 | 2 | 138 |
| Total | | 33 | 136 | 215 | 274 | 204 | 138 |
| Exact agreement % | | 100% | 98.50% | 98.60% | 99.60% | 99.00% | 100% |
| Agreement ± 1 block % | | 100% | 100% | 100% | 100% | 100% | 100% |
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A method comparison study was conducted to compare the test system's performance on measuring microalbumin and creatinine with Mission® U120 Ultra Urine Analyzer (K142391) using 979 clinical urine samples, and the results are summarized in the tables below.
| Microalbumin (N=979) | URIT UC-1800 Automatic Urine Analyzer (12FA test strips) | | | | |
| --- | --- | --- | --- | --- | --- |
| | | 10mg/L | 30mg/L | 80mg/L | 150mg/L |
| Predicate device (K142391) Mission® U120 Ultra Urine Analyzer Mission® Urinalysis Reagent Strips (Microalbumin/Creatinine) | 10mg/L | 527 | 8 | 0 | 0 |
| | 30mg/L | 14 | 75 | 9 | 0 |
| | 80mg/L | 0 | 7 | 168 | 3 |
| | 150mg/L | 0 | 0 | 3 | 165 |
| Total | | 541 | 90 | 180 | 168 |
| Exact agreement % | | 97.41% | 83.33% | 93.33% | 98.21% |
| Agreement ± 1 block % | | 100% | 100% | 100% | 100% |
| Creatinine (N=979) | URIT UC-1800 Automatic Urine Analyzer (12FA test strips) | | | | | |
| --- | --- | --- | --- | --- | --- | --- |
| | | 10mg/dL | 50mg/dL | 100mg/dL | 200mg/dL | 300mg/dL |
| Predicate device (K142391) Mission® U120 Ultra Urine Analyzer Mission® Urinalysis Reagent Strips (Microalbumin/Creatinine) | 10mg/dL | 52 | 3 | 0 | 0 | 0 |
| | 50mg/dL | 3 | 303 | 5 | 0 | 0 |
| | 100mg/dL | 0 | 4 | 418 | 7 | 0 |
| | 200mg/dL | 0 | 0 | 7 | 151 | 2 |
| | 300mg/dL | 0 | 0 | 0 | 4 | 20 |
| Total | | 55 | 310 | 430 | 162 | 22 |
| Complete agreement rate | | 94.55% | 97.74% | 97.21% | 93.21% | 90.91% |
| General agreement rate | | 100% | 100% | 100% | 100% | 100% |
A method comparison study was conducted for color and turbidity, as measured on the analyzer, with the comparator AUTION MAX AX-4030 Urinalysis System (K093098). 1365 clinical urine samples were tested to cover all grades of color the test system detects, and 1000 clinical urine samples were tested for the analytical measurement range of turbidity. The comparison results of Color and Turbidity are summarized in the tables below.
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| Color | Comparator AX-4030 | | | | | | | | |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| | | Colorless | Yellow | Red | Brown | Green | Orange | Blue | Violet |
| URIT UC-1800 Automatic Urine Analyzer | Colorless | 283 | 10 | 0 | 0 | 0 | 0 | 0 | 0 |
| | Yellow | 27 | 717 | 1 | 0 | 0 | 4 | 0 | 0 |
| | Red | 0 | 2 | 63 | 1 | 0 | 0 | 0 | 2 |
| | Brown | 0 | 0 | 1 | 65 | 0 | 0 | 0 | 0 |
| | Green | 0 | 0 | 0 | 0 | 37 | 0 | 1 | 0 |
| | Other | 0 | 0 | 0 | 0 | 2 | 72 | 39 | 38 |
| Total | | 310 | 729 | 65 | 66 | 39 | 76 | 40 | 40 |
| Coincidence rate | | 91.29% | 98.35% | 96.92% | 98.48% | 94.87% | 94.74% | 97.50% | 95.00% |
| Turbidity | Comparator AX-4030 | | | |
| --- | --- | --- | --- | --- |
| | | - | +1 | +2 |
| UC1800 | Clear | 898 | 0 | 0 |
| | Micro turbid | 10 | 42 | 0 |
| | Turbid | 0 | 25 | 1 |
| | Very turbid | 0 | 0 | 24 |
| Total | | 908 | 67 | 25 |
| Coincidence rate | | 98.90% | 100% | 96.00% |
2. Matrix Comparison:
Not applicable. This device is for testing with human urine only.
C Clinical Studies:
1. Clinical Sensitivity:
Not applicable.
2. Clinical Specificity:
Not applicable.
3. Other Clinical Supportive Data (When 1. and 2. Are Not Applicable):
Not applicable.
D Clinical Cut-Off:
Not applicable.
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# E Expected Values/Reference Range:
The Reference Range results were drawn from literatures and summarized in the table below.
| Analyte | Reference Range | Analyte | Reference Range |
| --- | --- | --- | --- |
| Leukocytes | Negative | Specific Gravity | 1.003~1.035 |
| Ketone | Negative | pH | 4.5~8.0 |
| Nitrite | Negative | Blood | Negative |
| Urobilinogen | (0.2~1.0) EU/dL | Glucose | Negative |
| Bilirubin | Negative | Creatinine | (10~300) mg/dL |
| Protein | Negative | Microalbumin | <20 mg/L |
| Ascorbic acid | 2-10 mg/dL | / | / |
# F Other Supportive Instrument Performance Characteristics Data:
Not applicable.
# VIII Proposed Labeling:
The labeling supports the finding of substantial equivalence for this device.
# IX Conclusion:
The submitted information in this premarket notification is complete and supports a substantial equivalence decision.
