URITEST 50 AND URITEST 500 URINE ANALYZER

{0} 1 # DECISION SUMMARY ASSAY AND INSTRUMENT COMBINATION TEMPLATE A. 510(k) Number: k091472 B. Purpose for Submission: New submission for URITEST 50 and URITEST 500 Analyzers for use with previously cleared URITEST 10 Urinalysis Strips (on Bayer Clinitek 50, 100, 200, 500 Analyzers and visual reading, k052719) C. Measurand: Blood, Glucose, Urobilinogen, Bilirubin, Ketone (acetoacetic acid), Protein, Nitrite, Leukocytes, pH and Specific Gravity in urine. D. Type of Test: Qualitative and semi-quantitative urine tests E. Applicant: ARJ Medical Inc. F. Proprietary and Established Names: URITEST 50 and URITEST 500 Urine Analyzers 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: Ketone (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 25 CFR §864.9320: Copper sulfate solution for specific gravity Determinations 21 CFR § 862.2900 Automated urinalysis system 2. Classification: Class II: Occult blood test and Urinary glucose (nonquantitative) test system. Class I: Automated urinalysis system, Urinary urobilinogen (nonquantitative) test system, Urinary bilirubin and its conjugates (nonquantitative) test system, Ketones {1} (nonquantitative) test system, Urinary protein or albumin (nonquantitative) test system, Nitrite (nonquantitative) test system, Leukocyte peroxidase test, Urinary pH (nonquantitative) test system and Copper sulfate solution for specific gravity determination. 3. Product code: - Occult blood test - JIO - Urinary glucose (non-quantitative) test system - JIL - Urinary urobilinogen (nonquantitative) test system - CDM - Urinary bilirubin and its conjugates (non-quantitative) 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 - Specific gravity – KSL - Automated Urinalysis System – KQO 4. Panel: - Chemistry (75), Hematology (81) H. Intended Use: 1. Intended use(s): See indications for use below. 2. Indication(s) for use: ARJ Medical URITEST 50 urine analyzers is a semi-automated, bench top instrument which is intended for prescription, in vitro diagnostic use with the URITEST 10 Urinalysis Reagent Strips manufactured by ARJ Medical, Inc. This system performs qualitative detection of Nitrites and semi-quantitative detection of Urobilinogen, Bilirubin, Ketone, Blood, Protein, Leukocytes, Glucose, Specific gravity and pH. The instrument uses the accompanying check strip for daily calibration. ARJ Medical URITEST 50 Urinalysis Analyzer is for use in professional near patient (point-of-care) facilities and centralized laboratory. The analyzer is 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 ARJ Medical URITEST 500 urine analyzers is a semi-automated, bench top instrument {2} which is intended for prescription, in vitro diagnostic use with the URITEST 10 Urinalysis Reagent Strips manufactured by ARJ Medical, Inc. This system performs qualitative detection of Nitrites and semi-quantitative detection of Urobilinogen, Bilirubin, Ketone, Blood, Protein, Leukocytes, Glucose, Specific gravity and pH. The instrument uses the accompanying check strip for daily calibration. ARJ Medical URITEST 500 Urinalysis Analyzer is for use in professional near patient (point-of-care) facilities and centralized laboratory. The analyzer is 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 3. Special conditions for use statement(s): For prescription use only. 4. Special instrument requirements: URITEST 50 and URITEST 500 Urine Analyzers I. Device Description: The ARJ Medical Uritest 50 and Uritest 500 urine analyzers are composed of an internal processor with memory, mechanical unit, liquid crystal display (LCD), photoelectric scanning unit, power system, keyboard, internal printer and standard RS-232 port. Uritest 10 reagent strips are dry chemistry reagent strips for use in urine. These strips measure urine glucose, pH, urobilinogen, bilirubin, protein, specific gravity, ketone, blood, leukocyte esterase and nitrite. J. Substantial Equivalence Information: 1. Predicate device name(s): URITEST Urinalysis Reagent Strips 2. Predicate 510(k) number(s): k052719 3. Comparison with predicate: | Similarities | | | | --- | --- | --- | | Item | Uritest 50 and Uritest 500 (Candidate device) | Clinitek 50 and Uritest 500 (Predicate device) | | Indications for use | Those systems can provide a qualitative result | Same | {3} 4 | Differences | | | | --- | --- | --- | | Item | Uritest 50 (Candidate device) | Clinitek 50 (Predicate device) | | Wavelength | 525nm, 572nm, 610nm, 660nm | 455nm, 550nm, 625nm, 845nm | | Test Throughput | Slow mode: 60 strips/hr Fast mode: 120 strips/hr | 60 strips/hr | | Differences | | | | --- | --- | --- | | Item | Uritest 500 (Candidate device) | Clinitek 500 (Predicate device) | | Wavelength | 525nm, 572nm, 610nm, 660nm | 455nm, 550nm, 625nm, 845nm | | Test Throughput | 514 strips/hr | 500 strips/hr | {4} K. Standard/Guidance Document Referenced (if applicable): CLSI EP10-A2: “Preliminary Evaluation of Quantitative Clinical Laboratory Methods” L. Test Principle: Uritest 50 and Uritest 500 urine analyzers: These analyzers are reflectance photometers that analyze the intensity and color of light reflected from the reagent areas of a urinalysis reagent strip. Using a light emitting diode (LED) as the light source and a photodiode as a light sensor, the optical system reads the color change in the urine strips after a sample is applied. Uritest 10 reagent strips: 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 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. 5 {5} M. Performance Characteristics (if/when applicable): 1. Analytical performance: a. Precision/Reproducibility: The sponsor evaluated precision of the devices using a protocol based on the CLSI EP10-A2, Preliminary Evaluation of Quantitative Clinical Laboratory Measurement Procedures: Analysis of the data for imprecision. Two levels of control materials (Bio-Rad Urinalysis Control, Level 1 and Level 2) were used to establish precision of the assay. Precision was performed at three point of care sites, with one strip lot, twice a day, for 20 non-consecutive days on both analyzers and by three operators for a total of 240 measurements. The results are summarized in the following tables: Uritest 50 | Urine analyte | Expected values Control level I and II | Expected result(s) determined by Comparative Method | Uritest 50 | % Agreement with expected results | n | | --- | --- | --- | --- | --- | --- | | Glucose | Negative | Negative | Negative | 100 | 240 | | Glucose | 250 - >2000 | 500 | 500 | 100 | 240 | | Bilirubin | Negative | Negative | Negative | 100 | 240 | | Bilirubin | Moderate – Large | Large | Large | 100 | 240 | | Ketone | Negative | Negative | Negative | 100 | 240 | | Ketone | 5 – 40 | 40 | 40 | 100 | 240 | | Specific gravity | 1.010 – 1.020 | 1.020 | 1.020 | 100 | 240 | | Specific gravity | 1.010 – 1.020 | 1.020 | 1.020 | 100 | 240 | | Blood | Negative | Negative | Negative | 100 | 240 | | Blood | Moderate – Large | Large | Large | 100 | 240 | | pH | 5.0 – 6.0 | 5.5 | 5.5 | 100 | 240 | | pH | 7.0 – 8.0 | 7.5 | 7.5 | 100 | 240 | | Protein | Negative | Negative | Negative | 100 | 240 | | Protein | 30 - > 300 | 300 | 300 | 100 | 240 | | Urobilinogen | 0.2 – 1.0 | 0.2 | 0.2 | 100 | 240 | | Urobilinogen | 4.0 – 8.0 | 8.0 | 8.0 | 100 | 240 | | Nitrate | Negative | Negative | Negative | 100 | 240 | | Nitrate | Positive | Positive | Positive | 100 | 240 | | Leukocytes | Negative | Negative | Negative | 100 | 240 | | Leukocytes | Small-large | Large | Large | 100 | 240 | {6} Uritest 500 | Urine analyte | Expected values Control level I and II | Expected result(s) determined by Comparative Method | Uritest 500 | % Agreement with expected results | n | | --- | --- | --- | --- | --- | --- | | Glucose | Negative | Negative | Negative | 100 | 240 | | Glucose | 250 - >2000 | 500 | 500 | 100 | 240 | | Bilirubin | Negative | Negative | Negative | 100 | 240 | | Bilirubin | Moderate – Large | Large | Large | 100 | 240 | | Ketone | Negative | Negative | Negative | 100 | 240 | | Ketone | 5 – 40 | 40 | 40 | 100 | 240 | | Specific gravity | 1.010 – 1.020 | 1.020 | 1.020 | 100 | 240 | | Specific gravity | 1.005 – 1.020 | 1.020 | 1.020 | 100 | 240 | | Blood | Negative | Negative | Negative | 100 | 240 | | Blood | Moderate – Large | Large | Large | 100 | 240 | | pH | 5.0 – 6.0 | 5.5 | 5.5 | 100 | 240 | | pH | 7.0 – 8.0 | 7.5 | 7.5 | 100 | 240 | | Protein | Negative | Negative | Negative | 100 | 240 | | Protein | 30 - > 300 | 300 | 300 | 100 | 240 | | Urobilinogen | 0.2 – 1.0 | 0.2 | 0.2 | 100 | 240 | | Urobilinogen | 4.0 – 8.0 | 8.0 | 8.0 | 100 | 240 | | Nitrate | Negative | Negative | Negative | 100 | 240 | | Nitrate | Positive | Positive | Positive | 100 | 240 | | Leukocytes | Negative | Negative | Negative | 100 | 240 | | Leukocytes | Small – Large | Large | Large | 100 | 240 | 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, across 3 lots of strips for a total of 60 measurements at each concentration. The company used Uritest 50 and Uritest 500 Urine analyzers to perform these measurements. For glucose, the company challenged their device with samples spiked to 50, 80, and 100 mg/dL. Glucose concentrations were independently determined using a commercial test {7} kit. The company found: Uritest 50 | 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 | 29 | 31 | 0 | 0 | 0 | 51.7 | | 80 mg/dL | 19 | 41 | 0 | 0 | 0 | 68.3 | | 100 mg/dL | 0 | 54 | 6 | 0 | 0 | 100.0 | Uritest 500 | 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 | 60 | 0 | 0 | 0 | 0 | 0.0 | | 50 | 28 | 32 | 0 | 0 | 0 | 53.3 | | 80 | 16 | 44 | 0 | 0 | 0 | 73.3 | | 100 | 0 | 52 | 7 | 1 | 0 | 100.0 | 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: Uritest 50 | Bilirubin [mg/dL] | Number of Strips reading at Negative | Number of Strips reading at “S” (0.3 mg/dL) | Number of Strips reading at “M” | Number of Strips reading at “L” | % Positive | | --- | --- | --- | --- | --- | --- | | 0 | 59 | 1 | 0 | 0 | 1.6 | | 0.2 | 41 | 19 | 0 | 0 | 31.7 | | 0.3 | 29 | 31 | 0 | 0 | 51.6 | | 0.5 | 4 | 56 | 0 | 0 | 93.3 | Uritest 500 | Bilirubin [mg/dL] | Number of Strips reading at Negative | Number of Strips reading at “S”(0.3/mg/dL) | Number of Strips reading at “M” | Number of Strips reading at “L” | % Positive | | --- | --- | --- | --- | --- | --- | | 0 | 60 | 0 | 0 | 0 | 0.0 | | 0.2 | 42 | 18 | 0 | 0 | 30 | | 0.3 | 27 | 33 | 0 | 0 | 55 | | 0.5 | 5 | 55 | 0 | 0 | 91.7 | {8} For ketones, the company challenged their device with 5, 10, and $15\mathrm{mg / dL}$ acetoacetate. The company found: Uritest 50 | Ketone [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 | Number of Strips reading at 80 mg/dL | % Positive | | --- | --- | --- | --- | --- | --- | --- | | 0 | 60 | 0 | 0 | 0 | 0 | 0.0 | | 5 | 13 | 47 | 0 | 0 | 0 | 78.3 | | 10 | 2 | 23 | 35 | 0 | 0 | 96.7 | | 15 | 0 | 2 | 56 | 2 | 0 | 100 | Uritest 500 | Ketone [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 | Number of Strips reading at 80 mg/dL | % Positive | | --- | --- | --- | --- | --- | --- | --- | | 0 | 60 | 0 | 0 | 0 | 0 | 0.0 | | 5 | 11 | 49 | 0 | 0 | 0 | 81.7 | | 10 | 3 | 23 | 34 | 0 | 0 | 95 | | 15 | 0 | 1 | 57 | 2 | 0 | 100 | 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: Uritest 50 | Blood [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 | Number of Strips reading at 200 mg/dL | % Positive | | --- | --- | --- | --- | --- | --- | --- | | 0 | 60 | 0 | 0 | 0 | 0 | 0.0 | | 5 | 32 | 24 | 4 | 0 | 0 | 46.6 | | 10 | 17 | 35 | 8 | 0 | 0 | 71.6 | | 15 | 8 | 20 | 32 | 0 | 0 | 86.7 | | 20 | 0 | 4 | 56 | 0 | 0 | 100.0 | Uritest 500 | Blood [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 | Number of Strips reading at 200 mg/dL | % Positive | | --- | --- | --- | --- | --- | --- | --- | | 0 | 60 | 0 | 0 | 0 | 0 | 0.0 | | 5 | 32 | 27 | 1 | 0 | 0 | 46.7 | | 10 | 18 | 34 | 8 | 0 | 0 | 70.0 | {9} 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 albumin into pooled urine negative to protein. Final concentrations were determined by use of a commercial total protein kit. The company found: Uritest 50 | Protein [mg/dL] | Number of Strips reading at: Negative | Number of Strips reading at: Trace (15/mg/dL) | Number of Strips reading at: 30 mg/dL | Number of Strips reading at: 100 mg/dL | Number of Strips reading at: 300 mg/dL | % Positive | | --- | --- | --- | --- | --- | --- | --- | | 0 | 60 | 0 | 0 | 0 | 0 | 0.0 | | 12 | 55 | 5 | 0 | 0 | 0 | 8.3 | | 15 | 22 | 38 | 0 | 0 | 0 | 63.3 | | 24 | 14 | 33 | 13 | 0 | 0 | 76.6 | | 30 | 0 | 1 | 53 | 6 | 0 | 100.0 | Uritest 500 | Protein [mg/dL] | Number of Strips reading at: Negative | Number of Strips reading at: Trace (15/mg/dL) | Number of Strips reading at: 30 mg/dL | Number of Strips reading at: 100 mg/dL | Number of Strips reading at: 300 mg/dL | % Positive | | --- | --- | --- | --- | --- | --- | --- | | 0 | 60 | 0 | 0 | 0 | 0 | 0.0 | | 12 | 49 | 11 | 0 | 0 | 0 | 18.3 | | 15 | 27 | 33 | 0 | 0 | 0 | 55.0 | | 24 | 12 | 37 | 11 | 0 | 0 | 80.0 | | 30 | 0 | 1 | 54 | 5 | 0 | 100.0 | For Urobilinogen, the company challenged their device using samples spiked to 0.2, 0.8, and 1.0 mg/dL urobilinogen. The company found: Uritest 50 | Urobilinogen [mg/dL] | Number of Strips reading at 0.8 mg/dL | Number of Strips reading at 1 mg/dL | Number of Strips reading at 2 mg/dL | Number of Strips reading at 4 mg/dL | Number of Strips reading at 8mg/dL | % Positive | | --- | --- | --- | --- | --- | --- | --- | | 0.2 | 59 | 1 | 0 | 0 | 0 | 1.6 | | 0.8 | 31 | 29 | 0 | 0 | 0 | 56.7 | | 1 | 2 | 58 | 0 | 0 | 0 | 96.7 | {10} Uritest 500 | Urobilinogen [mg/dL] | Number of Strips reading at 0.8 mg/dL | Number of Strips reading at 1 mg/dL | Number of Strips reading at 2 mg/dL | Number of Strips reading at 4 mg/dL | Number of Strips reading at 8 mg/dL | % Positive | | --- | --- | --- | --- | --- | --- | --- | | 0.2 | 60 | 0 | 0 | 0 | 0 | 0.0 | | 0.8 | 26 | 34 | 0 | 0 | 0 | 56.7 | | 1 | 1 | 59 | 0 | 0 | 0 | 98.3 | 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: Uritest 50 | Nitrite [mg/dL] | Number of Strips reading at: Negative | Number of Strips reading at: Positive (0.10 mg/dL) | % Positive | | --- | --- | --- | --- | | 0 | 58 | 2 | 3.3 | | 0.08 | 44 | 16 | 26.7 | | 0.10 | 23 | 37 | 61.7 | | 0.12 | 4 | 56 | 93.3 | Uritest 500 | Nitrite [mg/dL] | Number of Strips reading at: Negative | Number of Strips reading at: Positive (0/10mg/dl) | % Positive | | --- | --- | --- | --- | | 0 | 57 | 3 | 5.0 | | 0.08 | 43 | 17 | 28.3 | | 0.10 | 21 | 39 | 65.0 | | 0.12 | 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: Uritest 50 | 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 | 59 | 1 | 0 | 0 | 0 | 1.7 | | 5 | 41 | 19 | 0 | 0 | 0 | 31.7 | | 15 | 6 | 50 | 4 | 0 | 0 | 90.0 | | 25 | 0 | 8 | 42 | 10 | 0 | 100.0 | {11} Uritest 500 | 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 | 60 | 0 | 0 | 0 | 0 | 0.0 | | 5 | 42 | 18 | 0 | 0 | 0 | 30.0 | | 15 | 8 | 49 | 3 | 0 | 0 | 86.7 | | 25 | 0 | 7 | 39 | 14 | 0 | 100.0 | c. Traceability, Stability, Expected values (controls, calibrators, or methods): Previously cleared k052719 # d. Detection limit: The sensitivity of the assay when read by Uritest 50 and Uritest 500 analyzers was validated by spiking positive urine samples of known concentrations for each analyte please see M.1.b. above). The minimum sensitivity level for each analyte of the Uritest 10 strips when read by the Uritest 50 and Uritest 500 analyzers is defined by the sponsor as the concentration at which at least $50\%$ of the results are positive for that concentration. These positive samples of each analyte were then diluted to the lowest positive concentration on the Uritest color chart. Each urine sample was tested with three lots of the Uritest 10 strips in 20 replicates. The results of each analyte sensitivity pad are summarized in the table below: Uritest 50 | Analyte | Detection Range for Uritest 50 | Minimum Sensitivity | % Exact Color Match | | --- | --- | --- | --- | | Leukocytes | 0, 15, 70, 125, 500 | 15 Cells/μL | 90.0 | | Nitrites | Negative/Positive | 0.1 mg/dL | 61.7 | | Urobilinogen | 0.2, 1, 2, 4, 8 | 0.8 mg/dL | 56.7 | | Protein | 0, 15, 30, 100, 300, 2000 or more | 15 mg/dL | 63.3 | | Blood | 0, 10, 25, 80, 200 | 10 Cells/ μL | 71.6 | | Ketone | 0, 5, 15, 40, 80, 160 | 5 mg/dL | 78.3 | | Bilirubin | 0, 1, 2, 4 | 0.3 mg/dL | 51.6 | | Glucose | 0, 100, 250, 500, 1000, 2000 or more | 50 mg/dL | 51.7 | Uritest 500 | Analyte | Detection Range for Uritest 500 | Minimum Sensitivity | % Exact Color Match | | --- | --- | --- | --- | | Leukocytes | 0, 15, 70, 125, 500 | 15 Cells/μL | 86.7 | | Nitrites | Negative/Positive | 0.10 mg/dL | 65.0 | | Urobilinogen | 0.2, 1, 2, 4, 8 | 0.8 mg/dL | 56.7 | {12} | Protein | 0, 15, 30, 100, 300, 2000 or more | 15 mg/dL | 55.0 | | --- | --- | --- | --- | | Blood | 0, 10, 25, 80, 200 | 10 Cells/ μL | 70.0 | | Ketone | 0, 5, 15, 40, 80, 160 | 5 mg/dL | 81.7 | | Bilirubin | 0, 1, 2, 4 | 0.3 mg/dL | 55.0 | | Glucose | 0, 100, 250, 500, 1000, 2000 or more | 50 mg/dL | 53.3 | The lower limits of detection for pH and SG are as follows: 1.005 for SG and 5.0 for pH. # e. Analytical specificity: The sponsor tested a variety of endogenous and exogenous compounds for interference in negative and positive urine samples on the Uritest 50 analyzer. Fresh negative urine was spiked with the analyte of interest and the interfering analyte. The following analytes at the specified concentrations did not impact the results of the device: | Compound Tested | Concentration Used | | --- | --- | | Albumin | 800 mg/dL | | Citric Acid | 50 mg/dL | | Bilirubin | 3 mg/dL | | Creatine | 8 mg/dL | | Acetoacetate Acid | 1 mmol/L | | Ammonium Chloride | 189 mg/dL | | Calcium Chloride | 50 mg/dL | | Creatinine | 800 mg/dL | | Glycine | 1000 mg/dL | | KCl | 550 mg/dL | | NaCl | 2800 mg/dL | | Oxalic Acid | 70 mg/dL | | Sodium Acetate | 1200 mg/dL | | Sodium Bicarbonate | 1500 mg/dL | | Sodium Nitrate | 0.26 mg/dL | | Sodium Nitrite | 0.3 mg/dL | | Sodium Phosphate | 16 mg/dL | | Urobilinogen | 3 mg/dL | | Urea | 3000 mg/dL | | Riboflavin | 100 mg/dL | | Theophylline | 100 mg/dL | | Phenolphthalein | 1200 mg/dL | {13} The sponsor found that high levels of ketones (> 10 mgdL) and ascorbic acid (>8.8 mg/dL) would interfere with the measurements of glucose in urine using this device. The sponsor noted this interference in their product insert. The sponsor also noted that ascorbic acid at concentrations of 45 mg/dL or higher interfered with the device's detection of glucose, nitrate and bilirubin. Furthermore, ascorbic acid at concentrations of 100 mg/dL or higher interfered with the device's detection of blood, pH, leukocytes, specific gravity, protein, urobilinogen and ketone. Hemoglobin at concentrations of 50 mg/dL and higher interfered with the device's detection of blood. Glucose at concentrations of 2000 mg/dL or higher interfered with the device's detection of leukocytes. The sponsor noted those interferences in their product insert. A relationship is found between the Mesna concentration and the urinary test-strip reaction. The uroprotective drug mesna (sodium 2-mercaptoethane sulfonate) and other free-sulfhydryl compounds produce false-positive results in ketone methods that are based on the Legal reaction (alkaline sodium nitroprusside). The sponsor noted this interference in the product insert. f. Assay cut-off: Please see the Detection Limit section 1.d. above 2. Comparison studies: a. Method comparison with predicate device: The company performed a direct comparison using clinical samples at three point of care sites. The company compared the performance of their devices (Uritest 50 and Uritest 500 with the Uritest 10 strips) to their predicate devices (Clinitek 50 and Clinitek 500 with the Uritest 10 strips). Each sample was measured by three operators per site, for a total of 901 measurements. The company made measurements over 3 different manufacturing lots of the Uritest 10 strips. The results of each analyte on all four analyzers are summarized below: | Uritest 50 | 1000 | 0 | 0 | 0 | 3 | 26 | 89.7 | 100.0 | | --- | --- | --- | --- | --- | --- | --- | --- | --- | | | 500 | 0 | 0 | 16 | 221 | 5 | 91.3 | 100.0 | | | 250 | 0 | 4 | 46 | 2 | 0 | 88.5 | 100.0 | | | 100 | 2 | 55 | 1 | 0 | 0 | 94.8 | 100.0 | | | Neg | 520 | 0 | 0 | 0 | 0 | 100.0 | 100.0 | | | Glucose | Neg | 100 | 250 | 500 | 1000 | % Exact Color Block Match | % ± 1 Color Block | | | | Predicate Device | | | | | | | | 1000 | 0 | 0 | 0 | 2 | 27 | 93.1 | 100.0 | | --- | --- | --- | --- | --- | --- | --- | --- | {14} 15 | | 500 | 0 | 0 | 11 | 226 | 5 | 93.4 | 100.0 | | --- | --- | --- | --- | --- | --- | --- | --- | --- | | | 250 | 0 | 5 | 44 | 3 | 0 | 84.6 | 100.0 | | | 100 | 1 | 55 | 2 | 0 | 0 | 94.8 | 100.0 | | | Neg | 520 | 0 | 0 | 0 | 0 | 100.0 | 100.0 | | | Glucose | Neg | 100 | 250 | 500 | 1000 | % Exact Color Block Match | % ± 1 Color Block | | | | Predicate Device | | | | | | | | Uritest 50 | 200 | 0 | 0 | 0 | 6 | 106 | 94.6 | 100.0 | | --- | --- | --- | --- | --- | --- | --- | --- | --- | | | 80 | 0 | 0 | 3 | 62 | 3 | 92.5 | 100.0 | | | 25 | 0 | 12 | 94 | 1 | 1 | 87.0 | 99.1 | | | Trace | 3 | 90 | 1 | 0 | 0 | 95.7 | 100.0 | | | Neg | 518 | 2 | 0 | 0 | 0 | 99.6 | 100.0 | | | Blood | Neg | Trace | 25 | 80 | 200 | % Exact Color Block Match | % ± 1 Color Block | | | | Predicate Device | | | | | | | | Uritest 500 | 200 | 0 | 0 | 0 | 5 | 107 | 95.5 | 100.0 | | --- | --- | --- | --- | --- | --- | --- | --- | --- | | | 80 | 0 | 0 | 6 | 61 | 1 | 89.7 | 100.0 | | | 25 | 0 | 10 | 95 | 2 | 0 | 88.8 | 100.0 | | | Trace | 0 | 92 | 2 | 0 | 0 | 97.8 | 100.0 | | | Neg | 520 | 0 | 0 | 0 | 0 | 100.0 | 100.0 | | | Blood | Neg | Trace | 25 | 80 | 200 | % Exact Color Block Match | % ± 1 Color Block | | | | Predicate Device | | | | | | | | Uritest 50 | Large | 0 | 0 | 0 | 3 | 66 | 95.7 | 100.0 | | --- | --- | --- | --- | --- | --- | --- | --- | --- | | | Mod | 0 | 0 | 2 | 35 | 3 | 87.5 | 100.0 | | | Small | 0 | 6 | 97 | 2 | 0 | 92.4 | 100.0 | | | Trace | 6 | 159 | 3 | 0 | 0 | 94.6 | 100.0 | | | Neg | 520 | 0 | 0 | 0 | 0 | 100.0 | 100.0 | | | Leukocytes | Neg | Trace | Small | Mod | Large | % Exact Color Block Match | % ± 1 Color Block | | | | Predicate Device | | | | | | | {15} 16 | Uritest 500 | Large | 0 | 0 | 0 | 4 | 65 | 94.2 | 100.0 | | --- | --- | --- | --- | --- | --- | --- | --- | --- | | | Mod | 0 | 0 | 0 | 39 | 1 | 97.5 | 100.0 | | | Small | 0 | 5 | 100 | 0 | 0 | 95.2 | 100.0 | | | Trace | 9 | 156 | 2 | 0 | 0 | 93.4 | 100.0 | | | Neg | 520 | 0 | 0 | 0 | 0 | 100.0 | 100.0 | | | Leukocytes | Neg | Trace | Small | Mod | Large | % Exact ColorBlock Match | % ± 1 Color Block | | | | Predicate Device | | | | | | | | Uritest 50 | Pos | 7 | 374 | 98.2 | 100.0 | | --- | --- | --- | --- | --- | --- | | | Neg | 520 | 0 | 100.0 | 100.0 | | | Nitrite | Neg | Pos | % Exact Color Block Match | % ± 1 Color Block | | | | Predicate Device | | | | | Uritest 500 | Pos | 6 | 375 | 98.4 | 100.0 | | --- | --- | --- | --- | --- | --- | | | Neg | 520 | 0 | 100.0 | 100.0 | | | Nitrite | Neg | Pos | % Exact Color Block Match | % ± 1 Color Block | | | | Predicate Device | | | | | Uritest 50 | 300 | 0 | 0 | 0 | 4 | 46 | 92.0 | 100.0 | | --- | --- | --- | --- | --- | --- | --- | --- | --- | | | 100 | 0 | 0 | 4 | 57 | 3 | 89.1 | 100.0 | | | 30 | 0 | 6 | 207 | 3 | 0 | 95.8 | 100.0 | | | Trace | 1 | 49 | 1 | 0 | 0 | 96.1 | 100.0 | | | Neg | 520 | 0 | 0 | 0 | 0 | 100.0 | 100.0 | | | Protein | Neg | Trace | 30 | 100 | 300 | % Exact Color Block Match | % ± 1 Color Block | | | | Predicate Device | | | | | | | {16} 17 | Uritest 500 | 300 | 0 | 0 | 0 | 5 | 45 | 90.0 | 100.0 | | --- | --- | --- | --- | --- | --- | --- | --- | --- | | | 100 | 0 | 0 | 2 | 58 | 4 | 90.1 | 100.0 | | | 30 | 0 | 6 | 208 | 2 | 0 | 96.3 | 100.0 | | | Trace | 1 | 47 | 3 | 0 | 0 | 92.2 | 100.0 | | | Neg | 520 | 0 | 0 | 0 | 0 | 100.0 | 100.0 | | | Protein | Neg | Trace | 30 | 100 | 300 | % Exact Color Block Match | % ± 1 Color Block | | | | Predicate Device | | | | | | | | Uritest 50 | Large | 0 | 0 | 0 | 3 | 5 | 62.5 | 100.0 | | --- | --- | --- | --- | --- | --- | --- | --- | --- | | | Mod | 0 | 0 | 4 | 24 | 6 | 70.6 | 100.0 | | | Small | 0 | 8 | 120 | 3 | 0 | 91.6 | 100.0 | | | Trace | 8 | 198 | 2 | 0 | 0 | 95.2 | 100.0 | | | Neg | 520 | 0 | 0 | 0 | 0 | 100.0 | 100.0 | | | Ketones | Neg | Trace | Small | Mod | Large | % Exact Color Block Match | % ± 1 Color Block | | | | Predicate Device | | | | | | | | Uritest 500 | Large | 0 | 0 | 0 | 2 | 6 | 75.0 | 100.0 | | --- | --- | --- | --- | --- | --- | --- | --- | --- | | | Mod | 0 | 0 | 3 | 26 | 5 | 76.5 | 100.0 | | | Small | 0 | 6 | 122 | 3 | 0 | 93.1 | 100.0 | | | Trace | 8 | 197 | 3 | 0 | 0 | 94.7 | 100.0 | | | Neg | 520 | 0 | 0 | 0 | 0 | 100.0 | 100.0 | | | Ketones | Neg | Trace | Small | Mod | Large | % Exact Color Block Match | % ± 1 Color Block | | | | Predicate Device | | | | | | | {17} 18 | Uritest 50 | 8 | 0 | 0 | 0 | 1 | 2 | 66.7 | 100.0 | | --- | --- | --- | --- | --- | --- | --- | --- | --- | | | 4 | 0 | 0 | 4 | 8 | 2 | 57.1 | 100.0 | | | 2 | 0 | 1 | 34 | 0 | 0 | 97.1 | 100.0 | | | 1 | 7 | 319 | 3 | 0 | 0 | 96.9 | 100.0 | | | 0.2 | 520 | 0 | 0 | 0 | 0 | 100.0 | 100.0 | | | Urobilinogen | 0.2 | 1 | 2 | 4 | 8 | % Exact Color Block Match | % ± 1 Color Block | | | | Predicate Device | | | | | | % Exact Color Block Match | | Uritest 500 | 8 | 0 | 0 | 0 | 1 | 2 | 66.7 | 100.0 | | --- | --- | --- | --- | --- | --- | --- | --- | --- | | | 4 | 0 | 0 | 5 | 9 | 0 | 64.2 | 100.0 | | | 2 | 0 | 1 | 34 | 0 | 0 | 97.1 | 100.0 | | | 1 | 9 | 316 | 4 | 0 | 0 | 96.0 | 100.0 | | | 0.2 | 520 | 0 | 0 | 0 | 0 | 100.0 | 100.0 | | | Urobilinogen | 0.2 | 1 | 2 | 4 | 8 | % Exact Color Block Match | % ± 1 Color Block | | | | Predicate Device | | | | | | % Exact Color Block Match | | Uritest 50 | Lg | 0 | 0 | 5 | 8 | 61.5 | 100.0 | | --- | --- | --- | --- | --- | --- | --- | --- | | | Med | 0 | 1 | 7 | 0 | 87.5 | 100.0 | | | Sm | 9 | 349 | 2 | 0 | 96.9 | 100.0 | | | Neg | 520 | 0 | 0 | 0 | 100.0 | 100.0 | | | Bilirubin | Neg | Sm | Med | Lg | % Exact Color Block Match | % ± 1 Color Block | | | | Predicate Device | | | | % Exact Color Block Match | Bilirubin | {18} | Uritest 500 | Lg | 0 | 0 | 4 | 9 | 69.2 | 100.0 | | --- | --- | --- | --- | --- | --- | --- | --- | | | Med | 0 | 0 | 8 | 0 | 100.0 | 100.0 | | | Sm | 10 | 348 | 2 | 0 | 96.7 | 100.0 | | | Neg | 520 | 0 | 0 | 0 | 100.0 | 100.0 | | | Bilirubin | Neg | Sm | Med | Lg | % Exact Color Block Match | % ±1 Color Block | | | | Predicate Device | | | | | | | Uritest 50 | 9.0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 1 | 50.0 | 100.0 | | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | | | 8.5 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 3 | 0 | 75.0 | 100.0 | | | 8.0 | 0 | 0 | 0 | 0 | 0 | 3 | 5 | 0 | 0 | 62.5 | 100.0 | | | 7.5 | 0 | 0 | 0 | 0 | 8 | 24 | 0 | 0 | 0 | 75.0 | 100.0 | | | 7.0 | 0 | 0 | 2 | 11 | 67 | 1 | 0 | 0 | 0 | 82.7 | 97.5 | | | 6.5 | 0 | 1 | 11 | 218 | 0 | 0 | 0 | 0 | 0 | 94.8 | 99.6 | | | 6.0 | 1 | 3 | 298 | 0 | 0 | 0 | 0 | 0 | 0 | 98.7 | 99.7 | | | 5.5 | 16 | 190 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 92.2 | 100.0 | | | 5.0 | 34 | 4 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 89.5 | 100.0 | | | pH | 5.0 | 5.5 | 6.0 | 6.5 | 7.0 | 7.5 | 8.0 | 8.5 | 9.0 | % Exact Color Block Match | | | | | Predicate Device | | | | | | | | | | | {19} | Uritest 500 | 9.0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 2 | 100.0 | 100.0 | | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | | | 8.5 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 3 | 0 | 75.0 | 100.0 | | | 8.0 | 0 | 0 | 0 | 0 | 0 | 2 | 6 | 0 | 0 | 75.0 | 100.0 | | | 7.5 | 0 | 0 | 0 | 0 | 9 | 23 | 0 | 0 | 0 | 71.9 | 100.0 | | | 7.0 | 0 | 0 | 1 | 10 | 68 | 1 | 0 | 0 | 0 | 85.0 | 98.8 | | | 6.5 | 0 | 1 | 13 | 216 | 0 | 0 | 0 | 0 | 0 | 93.9 | 99.6 | | | 6.0 | 0 | 10 | 290 | 1 | 0 | 0 | 0 | 0 | 0 | 96.3 | 100.0 | | | 5.5 | 11 | 195 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 94.7 | 100.0 | | | 5.0 | 36 | 2 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 94.7 | 100.0 | | | pH | 5.0 | 5.5 | 6.0 | 6.5 | 7.0 | 7.5 | 8.0 | 8.5 | 9.0 | % % ±1 Color Exact Color Block Match | | | | | Predicate Device | | | | | | | | | | | | Uritest 50 | 1.030 | 0 | 0 | 0 | 0 | 2 | 6 | 214 | 96.4 | 99.1 | | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | | | 1.025 | 0 | 0 | 0 | 3 | 7 | 123 | 0 | 92.3 | 97.7 | | | 1.020 | 0 | 0 | 2 | 8 | 127 | 0 | 0 | 92.7 | 98.5 | | | 1.015 | 0 | 2 | 8 | 210 | 0 | 0 | 0 | 95.5 | 99.1 | | | 1.010 | 0 | 10 | 122 | 0 | 0 | 0 | 0 | 92.4 | 100.0 | | | 1.005 | 5 | 48 | 0 | 0 | 0 | 0 | 0 | 90.5 | 100.0 | | | 1.000 | 2 | 1 | 0 | 0 | 0 | 0 | 0 | 66.7 | 100.0 | | | Specific Gravity | 1.000 | 1.005 | 1.010 | 1.015 | 1.020 | 1.025 | 1.030 | % % ±1 Exact Color Block Match | | | | | Predicate Device | | | | | | | | | | Uritest 500 | 1.030 | 0 | 0 | 0 | 0 | 1 | 5 | 216 | 97.2 | 99.5 | | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | | | 1.025 | 0 | 0 | 0 | 2 | 9 | 122 | 0 | 93.1 | 98.5 | | | 1.020 | 0 | 0 | 0 | 9 | 126 | 0 | 0 | 93.3 | 100.0 | | | 1.015 | 0 | 0 | 14 | 204 | 0 | 0 | 0 | 93.5 | 100.0 | | | 1.010 | 2 | 11 | 119 | 2 | 0 | 0 | 0 | 88.8 | 98.5 | | | 1.005 | 7 | 46 | 0 | 0 | 0 | 0 | 0 | 86.8 | 100.0 | | | 1.000 | 2 | 1 | 0 | 0 | 0 | 0 | 0 | 66.7 | 100.0 | | | Specific Gravity | 1.000 | 1.005 | 1.010 | 1.015 | 1.020 | 1.025 | 1.030 | % % ±1 Exact Color Block Match | | | | | Predicate Device | | | | | | | | | {20} b. Matrix comparison: Not applicable. The devices only test urine samples. 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: Previously cleared k052719 N. Instrument Name: Uritest 50 Urinalysis Analyzer and Uritest 500 Urinalysis Analyzer O. System Descriptions: 1. Modes of Operation: Single and continuous testing mode 2. Software: FDA has reviewed applicant’s Hazard Analysis and software development processes for this line of product types: Yes ☐ X ☐ or No ☐ 3. Specimen Identification: Manual Patient ID entry {21} 4. Specimen Sampling and Handling: Single Step or Continuous Test Modes the strip is manual dip and the strip is placed on the strip holder. 5. Calibration: The instruments use the accompanying check strip for daily calibration. 6. Quality Control: Recommendations for testing quality control are provided in the labeling as follows: users should follow federal, state and local requirements for quality control testing. P. Other Supportive Instrument Performance Characteristics Data Not Covered In The "Performance Characteristics" Section above: Q. Proposed Labeling: The labeling is sufficient and it satisfies the requirements of 21 CFR Part 809.10. R. Conclusion: The submitted information in this premarket notification is complete and supports a substantial equivalence decision. 22