URITEST 10 URINALYSIS REAGENT STRIPS

K052719 · Arj Medical, Inc. · CDM · Dec 5, 2006 · Clinical Chemistry

Device Facts

• Record ID: K052719
• Device Name: URITEST 10 URINALYSIS REAGENT STRIPS
• Applicant: Arj Medical, Inc.
• Product Code: CDM · Clinical Chemistry
• Decision Date: Dec 5, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1785
• Device Class: Class 1

Indications for Use

URITEST 10 Urinalysis Reagent Strips provide qualitative and semi-quantitative tests for glucose, bilirubin, ketones (acetoacetic acid), specific gravity, blood, pH, protein, urobilinogen, nitrites, and leukocytes in urine. Test results may provide information regarding the status of carbohydrate metabolism, kidney and liver function, acid-base balance, and bacteriuria. ARJ Medical URITEST 10 Urinalysis Reagent Strips are for single use in professional near patient (point-of-care) facilities and centralized laboratory locations by medical technologists both read visually and on the Bayer Family of Clinitek Analyzers. The strips are intended for use in screening at-risk patients to assist diagnosis in the following areas: Kidney Function Urinary Tract infections Carbohydrate metabolism Liver Function Acid-Base balance Urine Concentration

Device Story

URITEST 10 Urinalysis Reagent Strips are firm plastic, dry reagent strips for urinalysis. Input: fresh, well-mixed, uncentrifuged urine sample. Operation: reagent areas dipped into urine; colorimetric reaction occurs. Output: visual color change read against chart or instrumental reading via Bayer Clinitek Urine Analyzers. Results available within 120 seconds. Used in professional POC facilities and centralized labs by medical technologists. Output assists in screening for kidney/liver function, UTI, carbohydrate metabolism, acid-base balance, and urine concentration; helps determine if microscopic analysis is required. Benefits patient by providing rapid diagnostic screening information.

Clinical Evidence

No clinical trials were performed. Substantial equivalence was established via analytical bench testing and method comparison studies. Precision was evaluated using commercial controls (10 measurements/level, 2x/day, 10 days). Linearity and detection limits were validated using spiked urine samples (n=60 per concentration). Method comparison involved 1,514 clinical samples measured in duplicate across five platforms (visual and four Clinitek analyzer models), showing high agreement with the predicate device.

Technological Characteristics

Firm plastic, dry reagent strips. 10-parameter test format (glucose, bilirubin, ketones, specific gravity, blood, pH, protein, urobilinogen, nitrites, leukocytes). Compatible with Bayer Clinitek Urine Analyzers for instrumental reading. Visual reading via color chart. Single-use.

Indications for Use

Indicated for professional use in point-of-care and centralized lab settings to screen at-risk patients for kidney function, urinary tract infections, carbohydrate metabolism, liver function, acid-base balance, and urine concentration. Provides qualitative/semi-quantitative results for glucose, bilirubin, ketones, specific gravity, blood, pH, protein, urobilinogen, nitrites, and leukocytes.

Regulatory Classification

Identification

A urinary urobilinogen (nonquantitative) test system is a device intended to detect and estimate urobilinogen (a bile pigment degradation product of red cell hemoglobin) in urine. Estimations obtained by this device are used in the diagnosis and treatment of liver diseases and hemolytic (red cells) disorders.

Predicate Devices

• Bayer Corporation MULTISTIX 10 SG Regent Strip (k852611)

Submission Summary (Full Text)

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# 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY ONLY TEMPLATE

A. 510(k) Number:
k052719

B. Purpose for Submission:
Clearance to market URITEST 10 Urinalysis Reagent Strips for urinalysis

C. Measurand:
Urobilinogen, bilirubin and its conjugates, ketones (acetoacetic acid), blood, glucose, protein, nitrite, leukocytes, glucose, specific gravity, and pH, in urine

D. Type of Test:
Qualitative and semi-quantitative urine tests

E. Applicant:
ARJ Medical Inc.

F. Proprietary and Established Names:
URITEST Urinalysis Reagent Strips

G. Regulatory Information:

1. Regulation section:
21 CFR §864.6550: Occult blood test.
21 CFR §862.1340: Urinary glucose (nonquantitative) test system.
21 CFR §862.1785: Urinary urobilinogen (nonquantitative) test system.
21 CFR §862.1115: Urinary bilirubin and its conjugates (nonquantitative) test system.
21 CFR §862.1435: Ketones (nonquantitative) test system.
21 CFR §862.1645: Urinary protein or albumin (nonquantitative) test system.
21 CFR §862.1510: Nitrite (nonquantitative) test system.
21 CFR §864.7675: Leukocyte peroxidase test.
21 CFR §862.1550: Urinary pH (nonquantitative) test system.

2. Classification:

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Class II: Urinary Glucose and Occult Blood

Class I: Urinary Leukocytes, Urinary pH, Nitrite, Urinary Protein, Ketones, Urinary Urobilinogen, Urinary Bilirubin

3. Product code:

Occult blood test - JIO
Urinary glucose (nonquantitative) test system - JIL
Urinary urobilinogen (nonquantitative) test system - CDM
Urinary bilirubin and its conjugates (nonquantitative) test system - JJB
Ketones (non-quantitative) test system - JIN
Urinary protein or albumin (non-quantitative) test system - JIR
Nitrite (non-quantitative) test system - JMT
Leukocyte peroxidase test - LJX
Urinary pH (nonquantitative) - CEN

4. Panel:

Chemistry (75)
Hematology (82)

H. Intended Use:

1. Intended use(s):

See indications for use below.

2. Indication(s) for use:

URITEST 10 Urinalysis Reagent Strips provide qualitative and semi-quantitative tests for glucose, bilirubin, ketones (acetoacetic acid), specific gravity, blood, pH, protein, urobilinogen, nitrites, and leukocytes in urine. Test results may provide information regarding the status of carbohydrate metabolism, kidney and liver function, acid-base balance, and bacteriuria.

ARJ Medical URITEST 10 Urinalysis Reagent Strips are for single use in professional near patient (point-of-care) facilities and centralized laboratory locations by medical technologists both read visually and on the Bayer Family of Clinitek Analyzers. The strips are intended for use in screening at-risk patients to assist diagnosis in the following areas:

Kidney Function
Urinary Tract infections
Carbohydrate metabolism
Liver Function
Acid-Base balance
Urine Concentration

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3. Special conditions for use statement(s):

For prescription use only

4. Special instrument requirements:

Bayer Clinitek 50, 100, 200, 500 Analyzers and visual readings.

I. Device Description:

URITEST 10 Urinalysis Reagent Strips provide qualitative and semi-quantitative for pH, specific gravity, ketones, blood, protein, nitrite, leukocytes, glucose, bilirubin, and urobilinogen in urine. URITEST 10 Urinalysis Reagent Strips are firm plastic, dry reagent strips. The reagent areas are dipped into the urine sample and read visually according to a color chart or are read instrumentally with a Bayer® Family of Clinitek Urine Analyzers. The results are available within 120 seconds. To obtain optimal results, it is necessary to use fresh, well-mixed and uncentrifuged urine.

J. Substantial Equivalence Information:

1. Predicate device name(s):

Bayer Corporation MULTISTIX 10 SG Regent Strip

2. Predicate 510(k) number(s):

k852611

3. Comparison with predicate:

| Similarities | | |
| --- | --- | --- |
| Item | Device | Predicate |
| Specimen | Urine | Same |
| Intended Use Audience | Patients of physicians, hospitals, and clinics | Same |
| Test Principles | Ingredients that change color in reaction with Analytes | Same |
| Output values | Negative and 2 to 6 positive values | Same |

K. Standard/Guidance Document Referenced (if applicable):

CLSI EP6-A: "Evaluation of Linearity of Quantitative Measurement Procedures: A Statistical Approach"; Approved Guideline, 2003

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CLSI EP09-A2: “Method Comparison and Bias Estimation Using Patient Samples”; Approved Guideline, 2002

CLSI EP10-A2: “Preliminary Evaluation of Quantitative Clinical Laboratory Methods”

CLSI EP12-A: “User Protocol for Evaluation of Qualitative Test Performance”; Approved Guideline, 2002

L. Test Principle:

The device is composed of multiple chemically reactive spots separate from each other on a plastic strip. Read-out is accomplished by visually matching the position and color of an exposed spot to a color coded chart provided with the device.

For the detection of urobilinogen, the device employs a modified Ehrlich’s reaction. Urobilinogen reacts with Ehrlich’s reagent to form a red-colored compound. Color changes from light orange-pink to dark pink.

For the detection of glucose, the device employs glucose oxidase to catalyze the oxidation of glucose to form hydrogen peroxide. The hydrogen peroxide thus formed then oxidizes a chromogen on the reaction pad by the action of peroxidase.

For the detection of bilirubin, bilirubin reacts with a dichlorobenzene diazonium salt in acid media to produce a colored product via an azo coupling. Bilirubin concentration is proportional to the intensity or the resulting purple color.

The device uses Legal’s test-nitroprusside reaction for the detection of ketones. Acetoacetic acid in an alkaline medium reacts with nitroferricyanide to produce a color change from beige to purple.

The device uses a correlation between the concentration of ionic species and the sample’s specific gravity to report an estimated specific gravity. Electrolyte (M+ X-) in the form of salt in urine reacts with poly-methyl vinyl ether and maleic acid which is a weak acid ionic exchanger. The reaction produces hydrogen ions which react with a pH indicator that causes a color change.

To detect blood, the device exploits the pseudo-peroxidase activity of the haem moiety of hemoglobin and myoglobin. A chromogen is oxidized by a hydroperoxide in the presence of haem and produces a green color.

To qualitatively estimate protein concentration, the device uses the “error of indicators” principle. Proteins interact with an ionizable electrolyte driving the release of protons which in turn interact with a spectator indicator. The color change in the indicator is correlated with the protein concentration.

The device detects nitrite through a reaction with an aromatic amino sulphanilamide

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to form a diazonium compound. The diazonium compound reacting with tetrahydro benzo(h)quinolin-3-phenol causes the color change.

One location on the strip contains an indoxyl ester and diazonium salt. Leukocytes contain an esterase that hydrolyzes the indoxyl ester. The liberated compound reacts with the diazonium salt on the strip to generate a purple compound. The concentration of leukocytes is correlated with the production of a purple color.

The device used two indicators to measure pH in a broad range of urinary pHs.

# M. Performance Characteristics (if/when applicable):

# 1. Analytical performance:

# a. Precision/Reproducibility:

The company demonstrated the precision of their device using 2 levels of commercial urine control. The company referenced CLSI EP10-A2 "Preliminary Evaluation of Quantitative Clinical Laboratory Methods" in determining the precision of their device. The company made 10 measurements per concentration level two times a day for 10 days for each of 3 lots of strips. Strips were read using a Clinitek 100 Urine Analyzer.

For the Level I material, the company found:

| Analyte | Reading | % Strips at Reading |
| --- | --- | --- |
| Urobilinogen | 3.2 | 100 |
| Bilirubin | Negative | 100 |
| Ketone | Negative | 100 |
| Blood | Negative | 100 |
| Protein | Negative | 100 |
| Nitrite | Negative | 100 |
| Leukocyte | Negative | 100 |
| Glucose | Negative | 100 |
| Specific Gravity | 1.02 | 100 |
| pH | 7.0 | 100 |

For the Level II material, the company found:

| Analyte | Reading | % Strips at Reading |
| --- | --- | --- |
| Urobilinogen | 3.2 | 100 |
| Bilirubin | Negative | 100 |
| Ketone | Negative | 100 |
| Blood | Negative | 100 |
| Protein | Negative | 100 |
| Nitrite | Negative | 100 |
| Leukocyte | Negative | 100 |
| Glucose | Negative | 100 |
| Specific Gravity | 1.02 | 100 |
| pH | 7.0 | 100 |

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| Urobilinogen | 66 | 100 |
| --- | --- | --- |
| Bilirubin | Moderate | 100 |
| Ketone | 1.5 | 100 |
| Blood | 200 | 100 |
| Protein | 3.0 | 100 |
| Nitrite | + | 100 |
| Leukocyte | 125 | 100 |
| Glucose | 28 | 100 |
| Specific Gravity | 1.02 | 100 |
| pH | 7.0 | 100 |

# b. Linearity/assay reportable range:

The company validated their claims for the concentration divisions by testing pooled, negative urine spiked to specific target concentrations. Each concentration of analyte was tested 20 times for across 3 lots of strips for a total of 60 measurements at each concentration. The company used 1 Clinitek 100 to perform these measurements.

For Urobilinogen, the company challenged their device using samples spiked to 0.2, 0.8, and $1.0\mathrm{mg / dL}$ urobilinogen. The company found:

| [Urobilinogen], mg/dL | Number of strips reading at: 0.2 mg/dL | Number of strips reading at: 1 mg/dL | Number of strips reading at: 2 mg/dL | % Positive |
| --- | --- | --- | --- | --- |
| 0.2 mg/dL | 58 | 2 | 0 | 0.7% |
| 0.8 mg/dL | 28 | 32 | 0 | 53.3% |
| 1.0 mg/dL | 1 | 59 | 0 | 98.3% |

For bilirubin, the company challenged their device using samples spiked to 0.2, 0.3, and $0.5\mathrm{mg / dL}$ bilirubin. The company found:

| [bilirubin], mg/dL | Number of strips reading at: Negative | Number of strips reading at: “S” | Number of strips reading at: “M” | Number of strips reading at: “L” | % Positive |
| --- | --- | --- | --- | --- | --- |
| 0 mg/dL | 59 | 1 | 0 | 0 | 0.3% |
| 0.8 mg/dL | 28 | 1 | 0 | 0 | 0.2% |
| 1.0 mg/dL | 1 | 59 | 0 | 0 | 0.0% |

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For ketones, the company challenged their device with 5, 10, and 15 md/dL acetoacetate. The company found:

| [ketones], mg/dL | Number of strips reading at: Negative | Number of strips reading at: 5 mg/dL | Number of strips reading at: 15 mg/dL | Number of strips reading at: 40 mg/dL | % Positive |
| --- | --- | --- | --- | --- | --- |
| 0 mg/dL | 60 | 0 | 0 | 0 | 0.0% |
| 5 mg/dL | 14 | 46 | 0 | 0 | 76.7% |
| 10 mg/dL | 1 | 24 | 35 | 0 | 98.3% |
| 15 mg/dL | 0 | 3 | 49 | 8 | 100.0% |

For blood, the company challenged their device with specimens adjusted to 5, 10, 15, 20 Cells/μL. A sample at 400 Cells/μL was diluted with negative, pooled urine. Cell counts were confirmed by microscopic examination. The company found:

| # RBC/μL | Number of strips reading at: Negative | Number of strips reading at: 10 mg/dL | Number of strips reading at: 25 mg/dL | Number of strips reading at: 80 mg/dL | % Positive |
| --- | --- | --- | --- | --- | --- |
| 0 RBC/μL | 59 | 1 | 0 | 0 | 1.7% |
| 5 RBC/μL | 34 | 25 | 1 | 0 | 42.9% |
| 10 RBC/μL | 20 | 32 | 8 | 0 | 66.7% |
| 15 RBC/μL | 8 | 19 | 33 | 0 | 87.1% |
| 20 RBC/μL | 0 | 3 | 57 | 0 | 100% |

For protein, the company challenged their device with urine containing 0.12, 0.15, 0.24, and 0.3 g/L protein. Samples were created by spiking human

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albumin into pooled urine negative to protein. Final concentrations were determined by use of a commercial total protein kit. The company found:

| [protein], mg/dL | Number of strips reading at: Negative | Number of strips reading at: Trace | Number of strips reading at: 30 mg/dL | Number of strips reading at: 100 mg/dL | % Positive |
| --- | --- | --- | --- | --- | --- |
| 0 mg/dL | 59 | 1 | 0 | 0 | 1.7% |
| 12 mg/dL | 58 | 2 | 0 | 0 | 3.3% |
| 15 mg/dL | 31 | 28 | 1 | 0 | 48.3% |
| 24 mg/dL | 17 | 33 | 10 | 0 | 71.7% |
| 30 mg/dL | 0 | 2 | 49 | 9 | 100% |

For nitrite, the company challenged their device with urine spiked to 0.08, 0.10, and 0.12 mg/dL. Nitrite concentrations were independently determined by a reference lab. The company found:

| [Nitrite], mg/dL | Number of strips reading at: Negative | Number of strips reading at: Positive | % Positive |
| --- | --- | --- | --- |
| 0.0 mg/dL | 59 | 1 | 1.7% |
| 0.08 mg/dL | 43 | 17 | 28.3% |
| 0.1 mg/dL | 25 | 35 | 58.3% |
| 0.12 mg/dL | 5 | 55 | 91.7% |

For leukocytes, the company challenged their device with sampled prepared with urine diluted from high cell count sample. Leukocytes counts were determined by microscopy. The company found:

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| #Leukocytes/μL | Number of strips reading at: Negative | Number of strips reading at: 15 /μL | Number of strips reading at: 70 /μL | Number of strips reading at: 125 /μL | Number of strips reading at: 500 /μL | % Positive |
| --- | --- | --- | --- | --- | --- | --- |
| 0 Leukocytes /μL | 59 | 1 | 0 | 0 | 0 | 1.7% |
| 5 Leukocytes /μL | 41 | 19 | 0 | 0 | 0 | 31.7% |
| 15 Leukocytes /μL | 10 | 46 | 4 | 0 | 0 | 83.3% |
| 25 Leukocytes /μL | 1 | 11 | 39 | 9 | 0 | 98.3% |

For glucose, the company challenged their device with samples spiked to 50, 72, and $100\mathrm{mg / dL}$ . Glucose concentrations were independently determined using a commercial test kit. The company found:

| [Glucose], mg/dL | Number of strips reading at: Negative | Number of strips reading at: 100 mg/dL | Number of strips reading at: 250 mg/dL | Number of strips reading at: 500 mg/dL | Number of strips reading at: 1000 mg/dL | % Positive |
| --- | --- | --- | --- | --- | --- | --- |
| 0 mg/dL | 60 | 0 | 0 | 0 | 0 | 0.0% |
| 50 mg/dL | 43 | 17 | 0 | 0 | 0 | 28.3% |
| 72 mg/dL | 21 | 38 | 1 | 0 | 0 | 65.0% |
| 100 mg/dL | 3 | 54 | 3 | 0 | 0 | 95.0% |

c. Traceability, Stability, Expected values (controls, calibrators, or methods):

The company assessed the stability of their proposed device using real-time aging studies. Different lots of manufactured strips were stored at both $2 - 8^{\circ}\mathrm{C}$ and $25^{\circ}\mathrm{C}$ for 18 months. Data provided by the company demonstrated that the performance of the aged device was comparable to that of newly manufactured strips.

The data provided by the company supports their claim for an 18 month shelf life when stored as indicated on the product insert.

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# d. Detection limit:

To substantiate their claims for a lower limit of detection, the company challenged their device with samples prepared at $80\%$ and $120\%$ of the lowest reported concentration. The company used 20 strips from each of 3 lots for a total of 60 measurements at each concentration, 180 measurements for each analyte. Samples were prepared and concentrations confirmed as in Section b) above.

For glucose, the company showed:

| Sample | 0.8*Cutoff | Cutoff | 1.2*Cutoff |
| --- | --- | --- | --- |
| Negative | 58 | 0 | 0 |
| Positive | 2 | 60 | 60 |
| % Correct | 96.7% | 100% | 100% |
| Cutoff Used: | 50 mg/dL | | |

For bilirubin, the company showed:

| Sample | 0.8*Cutoff | Cutoff | 1.2*Cutoff |
| --- | --- | --- | --- |
| Negative | 56 | 1 | 0 |
| Positive | 4 | 59 | 60 |
| % Correct | 93.3% | 98.3% | 100% |
| Cutoff Used: | 0.5 mg/dL | | |

For ketones, the company showed:

| Sample | 0.8*Cutoff | Cutoff | 1.2*Cutoff |
| --- | --- | --- | --- |
| Negative | 58 | 0 | 0 |
| Positive | 2 | 60 | 60 |
| % Correct | 96.7% | 100% | 100% |
| Cutoff Used: | 5 mg/dL | | |

For blood, the company showed:

| Sample | 0.8*Cutoff | Cutoff | 1.2*Cutoff |
| --- | --- | --- | --- |
| Negative | 55 | 0 | 0 |
| Positive | 5 | 60 | 60 |
| % Correct | 91.7% | 100% | 100% |
| Cutoff Used: | 10 RBC/μL | | |

For protein, the company showed:

| Sample | 0.8*Cutoff | Cutoff | 1.2*Cutoff |
| --- | --- | --- | --- |
| Negative | 56 | 2 | 0 |

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For urobilinogen, the company showed:

| Sample | 0.8*Cutoff | Cutoff | 1.2*Cutoff |
| --- | --- | --- | --- |
| Negative | 56 | 1 | 0 |
| Positive | 4 | 59 | 60 |
| % Correct | 93.3% | 98.3% | 100% |
| Cutoff Used: | 2 mg/dL | | |

For nitrites, the company showed:

| Sample | 0.8*Cutoff | Cutoff | 1.2*Cutoff |
| --- | --- | --- | --- |
| Negative | 59 | 0 | 0 |
| Positive | 1 | 60 | 60 |
| % Correct | 98.3% | 100% | 100% |
| Cutoff Used: | 0.05 mg/dL | | |

For leukocytes, the company showed:

| Sample | 0.8*Cutoff | Cutoff | 1.2*Cutoff |
| --- | --- | --- | --- |
| Negative | 54 | 4 | 0 |
| Positive | 6 | 56 | 60 |
| % Correct | 93.3% | 90.0% | 100% |
| Cutoff Used: | 25 WBC/μL | | |

# e. Analytical specificity:

The company tested a variety of endogenous and exogenous compounds in negative and positive urine samples. Fresh negative urine was spiked with the analyte of interest and the interfering analyte. The company found that the following analytes and concentrations did not impact the results of their device:

| Compound Tested | Concentration Used |
| --- | --- |
| Albumin | 800 mg/dL |
| Citric Acid | 50 mg/dL |
| Bilirubin | 3.0 mg/dL |
| Creatine | 8 mg/dL |
| Acetoacetate acid | 1 mM |
| Ammonium Chloride | 189 mg/dL |

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| Compound Tested | Concentration Used |
| --- | --- |
| Calcium Chloride | 50 mg/dL |
| Creatinine | 800 mg/dL |
| Glycine | 1000 mg/dL |
| KCl | 550 mg/dL |
| Oxalic Acid | 70 mg/dL |
| Sodium Bicarbonate | 1500 mg/dL |
| Sodium Nitrate | 0.26 mg/dL |
| Sodium Nitrite | 0.3 mg/dL |
| Sodium Phosphate | 16 mg/dL |
| Urea | 3000 mg/dL |
| Riboflavin | 100 mg/L |
| Theophylline | 100 mg/L |
| Phenolphthalein | 1200 mg/L |

The company did find that high levels of ketones ( $>10\mathrm{mg/dL}$ ) and ascorbic acid ( $>8.8\mathrm{mg/dL}$ ) would interfere with the measurements of glucose in urine using this device. The company noted this interference in their product literature.

The company also noted that ascorbic acid at concentrations of $8.8\mathrm{mg/dL}$ or higher interfered with the device's detection of blood. The company noted this interference in their product literature.

f. Assay cut-off:
Not applicable in this submission.

2. Comparison studies:

a. Method comparison with predicate device:

The company substantiated their claim for equivalence by direct comparison using clinical samples in four hospitals. The company compared the performance of their device to their predicate using visual comparison and on 4 different models of Clinitek analyzers. Each sample was measured in duplicate for a total of 10 measurements across the 5 platforms, i.e. visual reading by eight users and 4 analyzers, for a total of 1514 measurements. The company made measurements over 3 different manufacturing lots of the proposed device.

For glucose, the company determined:

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Reagent: Glucose
Instrument: Clinitek 50

| Proposed Device | 1000 | 0 | 0 | 0 | 2 | 162 |
| --- | --- | --- | --- | --- | --- | --- |
| | 500 | 0 | 0 | 3 | 112 | 3 |
| | 250 | 1 | 2 | 138 | 1 | 0 |
| | 100 | 2 | 171 | 0 | 0 | 0 |
| | Neg | 903 | 14 | 0 | 0 | 0 |
| | Glucose | Neg | 100 | 250 | 500 | 1000 |
| | | Predicate Device | | | | |

Reagent: Glucose
Instrument: Clinitek 100

| Proposed Device | 1000 | 0 | 0 | 0 | 2 | 165 |
| --- | --- | --- | --- | --- | --- | --- |
| | 500 | 0 | 0 | 3 | 108 | 4 |
| | 250 | 0 | 6 | 141 | 0 | 0 |
| | 100 | 4 | 168 | 0 | 0 | 0 |
| | Neg | 901 | 12 | 0 | 0 | 0 |
| | Glucose | Neg | 100 | 250 | 500 | 1000 |
| | | Predicate Device | | | | |

Reagent: Glucose
Instrument: Clinitek 200

| Proposed Device | 1000 | 0 | 0 | 0 | 2 | 168 |
| --- | --- | --- | --- | --- | --- | --- |
| | 500 | 0 | 0 | 4 | 106 | 7 |
| | 250 | 0 | 9 | 142 | 2 | 0 |
| | 100 | 5 | 161 | 0 | 0 | 0 |
| | Neg | 898 | 10 | 0 | 0 | 0 |
| | Glucose | Neg | 100 | 250 | 500 | 1000 |
| | | Predicate Device | | | | |

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Reagent: Glucose
Instrument: Chintek 500

| Proposed Device | 1000 | 0 | 0 | 0 | 2 | 168 |
| --- | --- | --- | --- | --- | --- | --- |
| | 500 | 0 | 0 | 2 | 114 | 3 |
| | 250 | 0 | 7 | 139 | 0 | 0 |
| | 100 | 2 | 167 | 1 | 0 | 0 |
| | Neg | 899 | 10 | 0 | 0 | 0 |
| | Glucose | Neg | 100 | 250 | 500 | 1000 |
| | | Predicate Device | | | | |

Reagent: Glucose
Instrument: Visual

| Proposed Device | ≥2000 | 0 | 0 | 0 | 0 | 12 | 89 |
| --- | --- | --- | --- | --- | --- | --- | --- |
| | 1000 | 0 | 0 | 0 | 6 | 54 | 0 |
| | 500 | 0 | 0 | 2 | 123 | 11 | 0 |
| | 250 | 0 | 5 | 163 | 2 | 0 | 0 |
| | 100 | 2 | 153 | 3 | 0 | 0 | 0 |
| | Neg | 886 | 3 | 0 | 0 | 0 | 0 |
| | Glucose | Neg | 100 | 250 | 500 | 1000 | ≥2000 |
| | | Predicate Device | | | | | |

For blood, the company determined:

Reagent: Blood
Instrument: Chintek 50

| Proposed Device | 200 | 0 | 0 | 0 | 8 | 191 |
| --- | --- | --- | --- | --- | --- | --- |
| | 80 | 0 | 0 | 12 | 99 | 5 |
| | 25 | 0 | 9 | 100 | 5 | 0 |
| | Trace | 8 | 122 | 3 | 0 | 0 |
| | Neg | 944 | 8 | 0 | 0 | 0 |
| | Blood | Neg | Trace | 25 | 80 | 200 |
| | | Predicate Device | | | | |

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Reagent: Blood
Instrument: Clinitek 100

| Proposed Device | 200 | 0 | 0 | 0 | 4 | 203 |
| --- | --- | --- | --- | --- | --- | --- |
| | 80 | 0 | 0 | 4 | 111 | 6 |
| | 25 | 0 | 3 | 110 | 4 | 0 |
| | Trace | 11 | 118 | 3 | 0 | 0 |
| | Neg | 924 | 8 | 0 | 0 | 0 |
| | Blood | Neg | Trace | 25 | 80 | 200 |
| | | Predicate Device | | | | |

Reagent: Blood
Instrument: Clinitek 200

| Proposed Device | 200 | 0 | 0 | 0 | 4 | 183 |
| --- | --- | --- | --- | --- | --- | --- |
| | 80 | 0 | 0 | 2 | 117 | 6 |
| | 25 | 0 | 3 | 110 | 3 | 0 |
| | Trace | 10 | 125 | 5 | 0 | 0 |
| | Neg | 937 | 9 | 0 | 0 | 0 |
| | Blood | Neg | Trace | 25 | 80 | 200 |
| | | Predicate Device | | | | |

Reagent: Blood
Instrument: Clinitek 500

| Proposed Device | 200 | 0 | 0 | 0 | 6 | 185 |
| --- | --- | --- | --- | --- | --- | --- |
| | 80 | 0 | 0 | 3 | 114 | 7 |
| | 25 | 0 | 2 | 105 | 3 | 0 |
| | Trace | 8 | 124 | 5 | 0 | 0 |
| | Neg | 941 | 11 | 0 | 0 | 0 |
| | Blood | Neg | Trace | 25 | 80 | 200 |
| | | Predicate Device | | | | |

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Reagent: Blood
Instrument: Visual

| Proposed Device | 200 | 0 | 0 | 0 | 6 | 183 |
| --- | --- | --- | --- | --- | --- | --- |
| | 80 | 0 | 0 | 6 | 109 | 7 |
| | 25 | 0 | 5 | 103 | 10 | 0 |
| | Trace | 6 | 122 | 3 | 0 | 0 |
| | Neg | 941 | 13 | 0 | 0 | 0 |
| | Blood | Neg | Trace | 25 | 80 | 200 |
| | | Predicate Device | | | | |

For leucocytes, the company determined:

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Reagent: Leucocytes
Instrument: Clinitek 50

| Proposed Device | Large | 0 | 0 | 0 | 1 | 136 |
| --- | --- | --- | --- | --- | --- | --- |
| | Mod | 0 | 0 | 2 | 116 | 2 |
| | Small | 0 | 1 | 196 | 3 | 0 |
| | Trace | 2 | 153 | 5 | 0 | 0 |
| | Neg | 893 | 4 | 0 | 0 | 0 |
| | Leukocytes | Neg | Trace | Small | Mod | Large |
| | | Predicate Device | | | | |

Reagent: Leucocytes
Instrument: Clinitek 100

| Proposed Device | Large | 0 | 0 | 0 | 1 | 134 |
| --- | --- | --- | --- | --- | --- | --- |
| | Mod | 0 | 0 | 2 | 118 | 6 |
| | Small | 0 | 1 | 196 | 3 | 0 |
| | Trace | 3 | 152 | 1 | 0 | 0 |
| | Neg | 894 | 2 | 0 | 0 | 0 |
| | Leukocytes | Neg | Trace | Small | Mod | Large |
| | | Predicate Device | | | | |

Reagent: Leucocytes
Instrument: Clinitek 200

| Proposed Device | Large | 0 | 0 | 0 | 1 | 137 |
| --- | --- | --- | --- | --- | --- | --- |
| | Mod | 0 | 0 | 3 | 121 | 0 |
| | Small | 0 | 1 | 197 | 2 | 0 |
| | Trace | 2 | 156 | 0 | 0 | 0 |
| | Neg | 893 | 1 | 0 | 0 | 0 |
| | Leukocytes | Neg | Trace | Small | Mod | Large |
| | | Predicate Device | | | | |

{17}

Reagent: Leucocytes
Instrument: Clinitek 500

| Proposed Device | Large | 0 | 0 | 0 | 3 | 115 |
| --- | --- | --- | --- | --- | --- | --- |
| | Mod | 0 | 0 | 6 | 124 | 4 |
| | Small | 0 | 4 | 197 | 6 | 0 |
| | Trace | 2 | 156 | 0 | 0 | 0 |
| | Neg | 891 | 6 | 0 | 0 | 0 |
| | Leukocytes | Neg | Trace | Small | Mod | Large |
| | | Predicate Device | | | | |

Reagent: Leucocytes
Instrument: Visual

| Proposed Device | Large | 0 | 0 | 0 | 1 | 119 |
| --- | --- | --- | --- | --- | --- | --- |
| | Mod | 0 | 0 | 3 | 122 | 3 |
| | Small | 0 | 3 | 204 | 5 | 0 |
| | Trace | 2 | 155 | 1 | 0 | 0 |
| | Neg | 893 | 3 | 0 | 0 | 0 |
| | Leukocytes | Neg | Trace | Small | Mod | Large |
| | | Predicate Device | | | | |

For nitrite, the company determined:

Reagent: Nitrite
Instrument: Clinitek 50

| Proposed Device | Pos | 0 | 594 |
| --- | --- | --- | --- |
| | Neg | 915 | 5 |
| | Nitrite | Neg | Pos |
| | | Predicate Device | |

{18}

19

Reagent: Nitrite
Instrument: Clinitek 100

| Proposed Device | Pos | 18 | 569 |
| --- | --- | --- | --- |
| | Neg | 918 | 9 |
| | Nitrite | Neg | Pos |
| | | Predicate Device | |

Reagent: Nitrite
Instrument: Clinitek 200

| Proposed Device | Pos | 6 | 582 |
| --- | --- | --- | --- |
| | Neg | 926 | 0 |
| | Nitrite | Neg | Pos |
| | | Predicate Device | |

Reagent: Nitrite
Instrument: Clinitek 500

| Proposed Device | Pos | 0 | 594 |
| --- | --- | --- | --- |
| | Neg | 915 | 5 |
| | Nitrite | Neg | Pos |
| | | Predicate Device | |

{19}

Reagent: Nitrite
Instrument: Visual

| Proposed Device | Pos | 18 | 569 |
| --- | --- | --- | --- |
| | Neg | 918 | 9 |
| | Nitrite | Neg | Pos |
| | | Predicate Device | |

For proteins, the company determined:

Reagent: Protein
Instrument: Clinitek 50

| Proposed Device | 300 | 0 | 0 | 00 | 9 | 162 |
| --- | --- | --- | --- | --- | --- | --- |
| | 100 | 0 | 0 | 3 | 113 | 1 |
| | 30 | 0 | 2 | 134 | 0 | 0 |
| | Trace | 0 | 174 | 2 | 0 | 0 |
| | Neg | 907 | 7 | 0 | 0 | 0 |
| | Protein | Neg | Trace | 30 | 100 | 300 |
| | | Predicate Device | | | | |

Reagent: Protein
Instrument: Clinitek 100

| Proposed Device | 300 | 0 | 0 | 0 | 10 | 169 |
| --- | --- | --- | --- | --- | --- | --- |
| | 100 | 0 | 0 | 3 | 111 | 0 |
| | 30 | 0 | 3 | 144 | 1 | 0 |
| | Trace | 0 | 173 | 5 | 0 | 0 |
| | Neg | 890 | 9 | 0 | 0 | |
| | Protein | Neg | Trace | 30 | 100 | 300 |
| | | Predicate Device | | | | |

{20}

Reagent: Protein
Instrument: Clinitek 200

| Proposed Device | 300 | 0 | 0 | 0 | 2 | 157 |
| --- | --- | --- | --- | --- | --- | --- |
| | 100 | 0 | 0 | 3 | 109 | 2 |
| | 30 | 0 | 3 | 135 | 1 | 0 |
| | Trace | 0 | 183 | 4 | 0 | 0 |
| | Neg | 902 | 13 | 0 | 0 | 0 |
| | Protein | Neg | Trace | 30 | 100 | 300 |
| | | Predicate Device | | | | |

Reagent: Protein
Instrument: Clinitek 500

| Proposed Device | 300 | 0 | 0 | 0 | 1 | 168 |
| --- | --- | --- | --- | --- | --- | --- |
| | 100 | 0 | 0 | 3 | 104 | 0 |
| | 30 | 0 | 0 | 139 | 5 | 0 |
| | Trace | 0 | 177 | 4 | 0 | 0 |
| | Neg | 903 | 10 | 0 | 0 | 0 |
| | Protein | Neg | Trace | 30 | 100 | 300 |
| | | Predicate Device | | | | |

Reagent: Protein
Instrument: Visual

| Proposed Device | ≥2000 | 0 | 0 | 0 | 0 | 0 | 125 |
| --- | --- | --- | --- | --- | --- | --- | --- |
| | 300 | 0 | 0 | 0 | 1 | 49 | 0 |
| | 100 | 0 | 0 | 0 | 105 | 0 | 0 |
| | 30 | 0 | 0 | 141 | 0 | 0 | 0 |
| | Trace | 0 | 178 | 0 | 0 | 0 | 0 |
| | Neg | 915 | 0 | 0 | 0 | 0 | 0 |
| | Protein | Neg | Trace | 30 | 100 | 300 | ≥2000 |
| | | Predicate Device | | | | | |

For ketones, the company determined:

{21}

Reagent: Ketones
Instrument: Clinitek 50

| Proposed Device | Large | 0 | 0 | 0 | 2 | 176 |
| --- | --- | --- | --- | --- | --- | --- |
| | Mod | 0 | 0 | 2 | 117 | 1 |
| | Small | 0 | 3 | 114 | 2 | 0 |
| | Trace | 0 | 190 | 2 | 0 | 0 |
| | Neg | 898 | 7 | 0 | 0 | 0 |
| | Ketones | Neg | Trace | Small | Mod | Large |
| | | Predicate Device | | | | |

Reagent: Ketones
Instrument: Clinitek 100

| Proposed Device | Large | 0 | 0 | 0 | 0 | 175 |
| --- | --- | --- | --- | --- | --- | --- |
| | Mod | 0 | 0 | 4 | 108 | 2 |
| | Small | 0 | 2 | 135 | 4 | 0 |
| | Trace | 1 | 173 | 2 | 0 | 0 |
| | Neg | 904 | 4 | 00 | 0 | 0 |
| | Ketones | Neg | Trace | Small | Mod | Large |
| | | Predicate Device | | | | |

Reagent: Ketones
Instrument: Clinitek 200

| Proposed Device | Large | 0 | 0 | 0 | 1 | 172 |
| --- | --- | --- | --- | --- | --- | --- |
| | Mod | 0 | 0 | 2 | 108 | 4 |
| | Small | 0 | 2 | 134 | 4 | 0 |
| | Trace | 0 | 174 | 3 | 0 | 0 |
| | Neg | 903 | 7 | 0 | 0 | 0 |
| | Ketones | Neg | Trace | Small | Mod | Large |
| | | Predicate Device | | | | |

{22}

23

Reagent: Ketones
Instrument: Clinitek 500

| Proposed Device | Large | 0 | 0 | 0 | 3 | 170 |
| --- | --- | --- | --- | --- | --- | --- |
| | Mod | 0 | 0 | 1 | 118 | 3 |
| | Small | 0 | 6 | 119 | 2 | 0 |
| | Trace | 0 | 182 | 2 | 0 | 0 |
| | Neg | 902 | 6 | 0 | 0 | 0 |
| | Ketones | Neg | Trace | Small | Mod | Large |
| | | Predicate Device | | | | |

Reagent: Ketones
Instrument: Visual

| Proposed Device | Large | 0 | 0 | 0 | 2 | 172 |
| --- | --- | --- | --- | --- | --- | --- |
| | Mod | 0 | 0 | 1 | 117 | 2 |
| | Small | 0 | 3 | 126 | 3 | 0 |
| | Trace | 0 | 182 | 5 | 0 | 0 |
| | Neg | 896 | 5 | 0 | 0 | 0 |
| | Ketones | Neg | Trace | Small | Mod | Large |
| | | Predicate Device | | | | |

For urobilinogen, the company determined:

Reagent: Urobilinogen
Instrument: Clinitek 50

| Proposed Device | 8 | 0 | 0 | 0 | 1 | 151 |
| --- | --- | --- | --- | --- | --- | --- |
| | 4 | 0 | 0 | 11 | 117 | 0 |
| | 2 | 0 | 5 | 143 | 2 | 0 |
| | 1 | 1 | 188 | 3 | 0 | 0 |
| | 0.2 | 889 | 3 | 0 | 0 | 0 |
| | Urobilinogen | 0.2 | 1 | 2 | 4 | 8 |
| | | Predicate Device | | | | |

{23}

Reagent: Urobilinogen
Instrument: Clinitek 100

| Proposed Device | 8 | 0 | 0 | 0 | 4 | 138 |
| --- | --- | --- | --- | --- | --- | --- |
| | 4 | 0 | 0 | 0 | 116 | 8 |
| | 2 | 0 | 3 | 154 | 3 | 0 |
| | 1 | 1 | 183 | 3 | 0 | 0 |
| | 0.2 | 891 | 10 | 0 | 0 | 0 |
| | Urobilinogen | 0.2 | 1 | 2 | 4 | 8 |
| | | Predicate Device | | | | |

Reagent: Urobilinogen
Instrument: Clinitek 200

| Proposed Device | 8 | 0 | 0 | 0 | 5 | 150 |
| --- | --- | --- | --- | --- | --- | --- |
| | 4 | 0 | 0 | 2 | 113 | 2 |
| | 2 | 0 | 5 | 146 | 0 | 0 |
| | 1 | 0 | 196 | 0 | 0 | 0 |
| | 0.2 | 885 | 10 | 0 | 0 | 0 |
| | Urobilinogen | 0.2 | 1 | 2 | 4 | 8 |
| | | Predicate Device | | | | |

Reagent: Urobilinogen
Instrument: Clinitek 500

| Proposed Device | 8 | 0 | 0 | 0 | 4 | 151 |
| --- | --- | --- | --- | --- | --- | --- |
| | 4 | 0 | 0 | 0 | 115 | 0 |
| | 2 | 0 | 3 | 147 | 1 | 0 |
| | 1 | 1 | 190 | 2 | 0 | 0 |
| | 0.2 | 888 | 12 | 0 | 0 | 0 |
| | Urobilinogen | 0.2 | 1 | 2 | 4 | 8 |
| | | Predicate Device | | | | |

{24}

Reagent: Urobilinogen
Instrument: Visual

| Proposed Device | 8 | 0 | 0 | 0 | 3 | 154 |
| --- | --- | --- | --- | --- | --- | --- |
| | 4 | 0 | 0 | 4 | 110 | 2 |
| | 2 | 0 | 4 | 150 | 3 | 0 |
| | 1 | 0 | 189 | 3 | 0 | 0 |
| | 0.2 | 884 | 8 | 0 | 0 | 0 |
| | Urobilinogen | 0.2 | 1 | 2 | 4 | 8 |
| | | Predicate Device | | | | |

For bilirubin, the company determined:

Reagent: Bilirubin
Instrument: Clinitek 50

| Proposed Device | Lg | 0 | 0 | 9 | 119 |
| --- | --- | --- | --- | --- | --- |
| | Med | 0 | 12 | 102 | 10 |
| | Sm | 5 | 360 | 14 | 0 |
| | Neg | 883 | 0 | 0 | 0 |
| | Bilirubin | Neg | Sm | Med | Lg |
| | | Predicate Device | | | |

Reagent: Bilirubin
Instrument: Clinitek 100

| Proposed Device | Lg | 0 | 0 | 4 | 116 |
| --- | --- | --- | --- | --- | --- |
| | Med | 0 | 2 | 120 | 16 |
| | Sm | 4 | 361 | 12 | 0 |
| | Neg | 873 | 6 | 0 | 0 |
| | Bilirubin | Neg | Sm | Med | Lg |
| | | Predicate Device | | | |

{25}

Reagent: Bilirubin
Instrument: Clinitek 200

| Proposed Device | Lg | 0 | 0 | 3 | 122 |
| --- | --- | --- | --- | --- | --- |
| | Med | 0 | 5 | 112 | 12 |
| | Sm | 0 | 371 | 4 | 0 |
| | Neg | 882 | 3 | 0 | 0 |
| | Bilirubin | Neg | Sm | Med | Lg |
| | | Predicate Device | | | |

Reagent: Bilirubin
Instrument: Clinitek 500

| Proposed Device | Lg | 0 | 0 | 2 | 120 |
| --- | --- | --- | --- | --- | --- |
| | Med | 0 | 0 | 122 | 3 |
| | Sm | 0 | 383 | 3 | 0 |
| | Neg | 871 | 10 | 0 | 0 |
| | Bilirubin | Neg | Sm | Med | Lg |
| | | Predicate Device | | | |

Reagent: Bilirubin
Instrument: Visual

| Proposed Device | Lg | 0 | 0 | 4 | 125 |
| --- | --- | --- | --- | --- | --- |
| | Med | 0 | 0 | 121 | 13 |
| | Sm | 4 | 357 | 7 | 0 |
| | Neg | 875 | 8 | 0 | 0 |
| | Bilirubin | Neg | Sm | Med | Lg |
| | | Predicate Device | | | |

For pH, the company determined:

{26}

Reagent: pH
Instrument: Clinitek 50

| Proposed Device | 8.5 | 0 | 0 | 0 | 0 | 0 | 2 | 14 | 128 |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| | 8.0 | 0 | 0 | 0 | 0 | 2 | 7 | 177 | 20 |
| | 7.5 | 0 | 0 | 0 | 0 | 18 | 163 | 6 | 0 |
| | 7.0 | 0 | 0 | 2 | 16 | 154 | 27 | 0 | 0 |
| | 6.5 | 0 | 0 | 12 | 185 | 6 | 0 | 0 | 0 |
| | 6.0 | 5 | 7 | 183 | 4 | 0 | 0 | 0 | 0 |
| | 5.5 | 12 | 160 | 7 | 1 | 0 | 0 | 0 | 0 |
| | 5.0 | 191 | 5 | 0 | 0 | 0 | 0 | 0 | 0 |
| | pH | 5.0 | 5.5 | 6.0 | 6.5 | 7.0 | 7.5 | 8.0 | 8.5 |
| | | Predicate Device | | | | | | | |

Reagent: pH
Instrument: Clinitek 100

| Proposed Device | 8.5 | 0 | 0 | 0 | 0 | 0 | 0 | 18 | 143 |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| | 8.0 | 0 | 0 | 0 | 0 | 0 | 12 | 170 | 3 |
| | 7.5 | 0 | 0 | 0 | 4 | 23 | 157 | 16 | 0 |
| | 7.0 | 0 | 0 | 0 | 4 | 163 | 4 | 0 | 0 |
| | 6.5 | 0 | 5 | 13 | 192 | 17 | 13 | 0 | 0 |
| | 6.0 | 0 | 5 | 181 | 6 | 0 | 0 | 0 | 0 |
| | 5.5 | 11 | 152 | 7 | 8 | 0 | 0 | 0 | 0 |
| | 5.0 | 177 | 10 | 0 | 0 | 0 | 0 | 0 | 0 |
| | pH | 5.0 | 5.5 | 6.0 | 6.5 | 7.0 | 7.5 | 8.0 | 8.5 |
| | | Predicate Device | | | | | | | |

{27}

Reagent: pH
Instrument: Clinitek 200

| Proposed Device | 8.5 | 0 | 0 | 0 | 0 | 0 | 0 | 8 | 143 |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| 8.0 | 0 | 0 | 0 | 0 | 0 | 9 | 162 | 12 |
| 7.5 | 0 | 0 | 0 | 0 | 2 | 176 | 2 | 0 |
| 7.0 | 0 | 0 | 0 | 19 | 175 | 11 | 0 | 0 |
| 6.5 | 0 | 0 | 3 | 194 | 3 | 0 | 0 | 0 |
| 6.0 | 0 | 5 | 172 | 13 | 0 | 0 | 0 | 0 |
| 5.5 | 5 | 178 | 14 | 2 | 0 | 0 | 0 | 0 |
| 5.0 | 201 | 5 | 0 | 0 | 0 | 0 | 0 | 0 |
| | pH | 5.0 | 5.5 | 6.0 | 6.5 | 7.0 | 7.5 | 8.0 | 8.5 |
| Predicate Device |

Reagent: pH
Instrument: Clinitek 500

| Proposed Device | 8.5 | 0 | 0 | 0 | 0 | 0 | 0 | 5 | 180 |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| 8.0 | 0 | 0 | 0 | 0 | 0 | 8 | 168 | 7 |
| 7.5 | 0 | 0 | 0 | 0 | 2 | 177 | 5 | 0 |
| 7.0 | 0 | 0 | 3 | 16 | 182 | 7 | 2 | 0 |
| 6.5 | 0 | 0 | 9 | 179 | 5 | 0 | 0 | 0 |
| 6.0 | 0 | 7 | 185 | 4 | 0 | 0 | 0 | 0 |
| 5.5 | 5 | 164 | 6 | 0 | 0 | 0 | 0 | 0 |
| 5.0 | 182 | 6 | 0 | 0 | 0 | 0 | 0 | 0 |
| | pH | 5.0 | 5.5 | 6.0 | 6.5 | 7.0 | 7.5 | 8.0 | 8.5 |
| Predicate Device |

Reagent: pH
Instrument: Visual

| Proposed Device | 8.5 | 0 | 0 | 0 | 0 | 0 | 0 | 23 | 237 |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| | 8.0 | 0 | 0 | 0 | 0 | 0 | 4 | 136 | 14 |
| | 7.5 | 0 | 0 | 0 | 1 | 13 | 150 | 2 | 4 |
| | 7.0 | 0 | 0 | 0 | 9 | 149 | 19 | 0 | 0 |
| | 6.5 | 0 | 1 | 3 | 167 | 21 | 2 | 0 | 0 |
| | 6.0 | 2 | 7 | 161 | 18 | 1 | 0 | 0 | 0 |
| | 5.5 | 4 | 163 | 13 | 0 | 0 | 0 | 0 | 0 |
| | 5.0 | 185 | 5 | 0 | 0 | 0 | 0 | 0 | 0 |
| | pH | 5.0 | 5.5 | 6.0 | 6.5 | 7.0 | 7.5 | 8.0 | 8.5 |
| | | Predicate Device | | | | | | | |

For specific gravity, the company determined:

{28}

Reagent: SG
Instrument: Clinitek 50

| Proposed Device | 1.030 | 0 | 0 | 0 | 0 | 0 | 6 | 178 |
| --- | --- | --- | --- | --- | --- | --- | --- | --- |
| | 1.025 | 0 | 0 | 0 | 0 | 0 | 224 | 14 |
| | 1.020 | 0 | 0 | 0 | 0 | 213 | 2 | 0 |
| | 1.015 | 0 | 0 | 3 | 269 | 1 | 0 | 0 |
| | 1.010 | 0 | 3 | 288 | 2 | 0 | 0 | 0 |
| | 1.005 | 0 | 284 | 2 | 0 | 0 | 0 | 0 |
| | 1.000 | 25 | 0 | 0 | 0 | 0 | 0 | 0 |
| | Specific Gravity | 1.000 | 1.005 | 1.010 | 1.015 | 1.020 | 1.025 | 1.030 |
| | | Predicate Device | | | | | | |

Reagent: SG
Instrument: Clinitek 100

| Proposed Device | 1.030 | 0 | 0 | 0 | 0 | 0 | 1 | 99 |
| --- | --- | --- | --- | --- | --- | --- | --- | --- |
| | 1.025 | 0 | 0 | 0 | 0 | 12 | 191 | 2 |
| | 1.020 | 0 | 0 | 0 | 6 | 182 | 5 | 0 |
| | 1.015 | 0 | 0 | 3 | 270 | 0 | 0 | 0 |
| | 1.010 | 0 | 3 | 378 | 4 | 0 | 0 | 0 |
| | 1.005 | 0 | 326 | 7 | 0 | 0 | 0 | 0 |
| | 1.000 | 25 | 0 | 0 | 0 | 0 | 0 | 0 |
| | Specific Gravity | 1.000 | 1.005 | 1.010 | 1.015 | 1.020 | 1.025 | 1.030 |
| | | Predicate Device | | | | | | |

{29}

Reagent: SG Instrument: Clinitek 200

| Proposed Device | 1.030 | 0 | 0 | 0 | 0 | 0 | 1 | 99 |
| --- | --- | --- | --- | --- | --- | --- | --- | --- |
| | 1.025 | 0 | 0 | 0 | 0 | 7 | 190 | 2 |
| | 1.020 | 0 | 0 | 0 | 5 | 182 | 0 | 0 |
| | 1.015 | 0 | 0 | 14 | 270 | 1 | 0 | 0 |
| | 1.010 | 0 | 28 | 375 | 2 | 0 | 0 | 0 |
| | 1.005 | 0 | 310 | 3 | 0 | 0 | 0 | 0 |
| | 1.000 | 25 | 0 | 0 | 0 | 0 | 0 | 0 |
| | Specific Gravity | 1.000 | 1.005 | 1.010 | 1.015 | 1.020 | 1.025 | 1.030 |
| | | Predicate Device | | | | | | |

Reagent: SG Instrument: Clinitek 500

| Proposed Device | 1.030 | 0 | 0 | 0 | 0 | 0 | 0 | 98 |
| --- | --- | --- | --- | --- | --- | --- | --- | --- |
| | 1.025 | 0 | 0 | 0 | 0 | 17 | 194 | 0 |
| | 1.020 | 0 | 0 | 0 | 22 | 158 | 7 | 0 |
| | 1.015 | 0 | 0 | 21 | 238 | 3 | 0 | 0 |
| | 1.010 | 0 | 29 | 385 | 1 | 0 | 0 | 0 |
| | 1.005 | 0 | 307 | 9 | 0 | 0 | 0 | 0 |
| | 1.000 | 25 | 0 | 0 | 0 | 0 | 0 | 0 |
| | Specific Gravity | 1.000 | 1.005 | 1.010 | 1.015 | 1.020 | 1.025 | 1.030 |
| | | Predicate Device | | | | | | |

Reagent: SG Instrument: Visual

| Proposed Device | 1.030 | 0 | 0 | 0 | 0 | 0 | 30 | 191 |
| --- | --- | --- | --- | --- | --- | --- | --- | --- |
| | 1.025 | 0 | 0 | 0 | 0 | 9 | 194 | 0 |
| | 1.020 | 0 | 0 | 0 | 15 | 211 | 0 | 0 |
| | 1.015 | 0 | 0 | 1 | 270 | 6 | 0 | 0 |
| | 1.010 | 0 | 2 | 235 | 2 | 0 | 0 | 0 |
| | 1.005 | 0 | 315 | 8 | 0 | 0 | 0 | 0 |
| | 1.000 | 25 | 0 | 0 | 0 | 0 | 0 | 0 |
| | Specific Gravity | 1.000 | 1.005 | 1.010 | 1.015 | 1.020 | 1.025 | 1.030 |
| | | Predicate Device | | | | | | |

A summary of the company's findings:

| Analyte | Test Method | Total | Agreement (%) |
| --- | --- | --- | --- |
| Glucose | Clinitek 50 | 1514 | 98.2 |
| | Clinitek 100 | 1514 | 97.9 |
| | Clinitek 200 | 1514 | 97.4 |
| | Clinitek 500 | 1514 | 98.2 |
| | Visual | 1514 | 96.9 |

{30}

| Analyte | Test Method | Total | Agreement (%) |
| --- | --- | --- | --- |
| Blood | Clinitek 50 | 1514 | 96.2 |
| | Clinitek 100 | 1514 | 97.2 |
| | Clinitek 200 | 1514 | 97.3 |
| | Clinitek 500 | 1514 | 97 |
| | Visual | 1514 | 96.3 |
| Leukocytes | Clinitek 50 | 1514 | 98.7 |
| | Clinitek 100 | 1514 | 98.6 |
| | Clinitek 200 | 1514 | 99.3 |
| | Clinitek 500 | 1514 | 97.9 |
| | Visual | 1514 | 98.6 |
| Nitrite | Clinitek 50 | 1514 | 99.7 |
| | Clinitek 100 | 1514 | 98.2 |
| | Clinitek 200 | 1514 | 99.6 |
| | Clinitek 500 | 1514 | 99.7 |
| | Visual | 1514 | 98.2 |
| Protein | Clinitek 50 | 1514 | 98.4 |
| | Clinitek 100 | 1514 | 98.2 |
| | Clinitek 200 | 1514 | 98.2 |
| | Clinitek 500 | 1514 | 98.5 |
| | Visual | 1514 | 99.9 |
| Ketones | Clinitek 50 | 1514 | 98.7 |
| | Clinitek 100 | 1514 | 98.7 |
| | Clinitek 200 | 1514 | 98.4 |
| | Clinitek 500 | 1514 | 98.5 |
| | Visual | 1514 | 98.6 |
| Urobilinogen | Clinitek 50 | 1514 | 98.2 |
| | Clinitek 100 | 1514 | 97.9 |
| | Clinitek 200 | 1514 | 98.4 |
| | Clinitek 500 | 1514 | 98.5 |
| | Visual | 1514 | 98.2 |
| Bilirubin | Clinitek 50 | 1514 | 96.7 |
| | Clinitek 100 | 1514 | 97.1 |
| | Clinitek 200 | 1514 | 98.2 |
| | Clinitek 500 | 1514 | 98.8 |
| | Visual | 1514 | 97.6 |
| pH | Clinitek 50 | 1514 | 88.6 |
| | Clinitek 100 | 1514 | 88.2 |
| | Clinitek 200 | 1514 | 92.5 |
| | Clinitek 500 | 1514 | 93.6 |
| | Visual | 1514 | 89 |
| Specific Gravity | Clinitek 50 | 1514 | 97.8 |
| | Clinitek 100 | 1514 | 97.2 |
| | Clinitek 200 | 1514 | 95.9 |
| | Clinitek 500 | 1514 | 92.8 |
| | Visual | 1514 | 95.2 |

The data supplied by the company substantiates their claim for equivalence.

{31}

b. Matrix comparison:
Not applicable in this submission.

3. Clinical studies:
a. Clinical Sensitivity:
Not applicable
b. Clinical specificity:
Not applicable
c. Other clinical supportive data (when a. and b. are not applicable):
Not applicable

4. Clinical cut-off:
Not applicable

5. Expected values/Reference range:
The company indicated the following references ranges for the analytes detected with this device*:
Urobilinogen: 0 -1.0 mg/dL
Bilirubin: Negative on this device.
Ketone: Negative on this device.
Blood: Negative to "Trace"
Protein: Negative on this device.
Nitrite: Negative on this device.
Leukocytes: Negative on this device.
Glucose: Negative on this device.
Specific Gravity: 1.003-1.035.
pH: 4.6 to 8.0

*"European Urinalysis Guidelines", The Scandinavian Journal of Clinical & Laboratory Investigation, Scand J. Clin. Lab. Invest. Vol. 60-Supplement 231.2000.

N. Proposed Labeling:
The labeling is sufficient and it satisfies the requirements of 21 CFR Part 809.10.

{32}

O. Conclusion:

The submitted information in this premarket notification is complete and supports a substantial equivalence decision.

33