WIENER LAB. URINE STRIP 10 AND 11

{0} 1 # 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY ONLY TEMPLATE A. 510(k) Number: k083724 B. Purpose for Submission: New device C. Measurand: Glucose, blood, leukocytes, specific gravity, pH, nitrite, protein, ketone, urobilinogen, ascorbic acid and bilirubin in urine D. Type of Test: Qualitative and semi-quantitative visual read E. Applicant: Wiener Laboratories S.A.I.C. F. Proprietary and Established Names: Wiener lab. Urine Strip G. Regulatory Information: | Product Code | Classification | Regulation Section | Panel | | --- | --- | --- | --- | | JIL-Urinary glucose (nonquantitative) test system | II | 21 CFR§ 862.1340 | 75, Chemistry | | JIO-Occult blood test | II | 21 CFR§ 864.6550 | 81 Hematology | | LJX-Leukocyte peroxidase test | I | 21 CFR§ 864.7675 | 81 Hematology | | CEN-Urinary pH (nonquantitative) test system | I | 21 CFR§ 862.1550 | 75Chemistry | | JMT- Nitrite (nonquantitative) test system | I | 21 CFR§ 862.1510 | 75 Chemistry | | JIR-Urinary protein or albumin (nonquantitative) test system | I | 21 CFR§ 862.1645 | 75 Chemistry | {1} 2 | JIN-Ketones (nonquantitative) test system | I | 21 CFR§ 862.1435 | 75 Chemistry | | --- | --- | --- | --- | | CDM-Urinary urobilinogen (nonquantitative) test system | I | 21 CFR§ 862.1785 | 75 Chemistry | | JJB-Urinary bilirubin and its conjugates (nonquantitative) test system | I | 21 CFR§ 862.1115 | 75 Chemistry | | JMA-Ascorbic Acid test system | I | 21 CFR§ 862.1095 | 75 Chemistry | H. Intended Use: 1. Intended use(s): See indications for use below. 2. Indication(s) for use: Urine strip test strips are for “in vitro” diagnostic use and are intended for prescription use near-patient (point of care) and centralized laboratory locations. Urine Strip includes test pads for qualitative and semi-quantitative determination of urobilinogen, glucose, ketones, bilirubin, proteins, nitrite, pH, blood, specific gravity, leukocytes and ascorbic acid in urine. Urine test strips results may provide information regarding the status of carbohydrate metabolism, kidney and liver function, acid-base balance and urinary tract infections. Test results can be used along with other diagnostic information to rule out certain disease states and to determine if microscopic analysis is needed. The test is to be read visually. 3. Special conditions for use statement(s): For prescription use 4. Special instrument requirements: Not applicable. The device is a visually read single use device. I. Device Description: The Wiener lab Urine Strips are in vitro diagnostic reagents strips containing dry chemicals for the qualitative and semi-quantitative detection of urobilinogen, glucose, ketones, bilirubin, proteins, nitrite, pH, blood, specific gravity, leukocytes and ascorbic acid in urine. The sample reacts with the solid phase dry chemical reagent {2} pads attached to a plastic holder. The results are obtained by the direct comparison of the reagent strip with the color blocks on the bottle label. The entire reagent is disposable after use. Laboratory instrumentation is not required. ## J. Substantial Equivalence Information: 1. Predicate device name(s): Bayer Multistix 10 SG and Teco Diagnostics Clinistrip 2. Predicate 510(k) number(s): k960546 and k970250, respectively 3. Comparison with predicate: | Similarities | | | | --- | --- | --- | | Item | Device | Predicate | | Intended Use | Prescription use | Same | | Intended Specimen | Urine | Same | | Material Provided | Plastic strips affixed with several separate dry reagent pads. | Same | | Glucose Methodology | Same | Same | | Ketone Methodology | Same | Same | | Specific Gravity Methodology | Same | Same | | pH Methodology | Same | Same | | Protein Methodology | Same | Same | | Differences | | | | --- | --- | --- | | Item | Device | Predicate | | Bilirubin Methodology | Based on the coupling of bilirubin with 2,4-dichlorophenyl diazonium salt in a strong acid medium | Based on the union of bilirubin and diazotized dichloroanilyne in strongly acid medium | {3} | Blood Methodology | Based on the pseudoperoxidase activity of hemoglobin, which catalyzes the reaction of 3,3',5,5'-tetramethylbenzidine with buffered organic hydroperoxide | Based on the hemoglobin peroxidase like activity of hemoglobin, which catalyzes the reaction of diisopropylbenzene andihydroperoxide and 3,3',5,5'-tetramethylbenzidine | | --- | --- | --- | | Urobilinogen Methodology | Based on the diazotization reaction of a diazonium salt and urinary urobilinogen in a strong acid medium | Based on a modified Erlich reaction in which p-diethylaminobenzaldehyde in conjunction with a color enhancer reacts with urobilinogen in a strongly acidic medium | | Nitrite Methodology | Based on the reaction of the p-arsanilic acid and nitrite, derived from a dietary nitrite in the presence of bacteria in urine, to form a diazonium compound. This compound reacts with N(-1-naphthyl)-ethylenediamine in an acidic medium. | Based on the reaction of urinary nitrite and p-arsenilic acid, forming a diazonium compound. This compound reacts with 1,2,3,4-tetrahydrobenzo(h)quinoline-3-ol | | Leukocytes Methodology | Based on the presence of granulocyte esterases. The esterases cleave a pyrazol ester derivate to release hydroxypyrazol derivative. This derivative reacts with diazonium salt to produce a purple product | Granulocyte leukocytes contain esterases that catalyze the hydrolysis of the derivatized pyrrole that react with diazonium salt to produce a purple color. | | Working Temperature Range Storage | < 30°C | 15 to 30°C | | Test Time | 60 seconds-2 minutes | 30 seconds -2 minutes | K. Standard/Guidance Document Referenced (if applicable): None were referenced. L. Test Principle: Glucose: is based on a sequential enzyme reaction. First, glucose oxidase catalyzes the formation of gluconic acid and hydrogen peroxide from the oxidation of glucose. Then, {4} peroxidase catalyzes the reaction of hydrogen peroxide with potassium iodide to colors ranging from greenish light-blue through greenish-brown and then to brown. Bilirubin: is based on the coupling of bilirubin with 2,4-dichlorophenyl diazonium salt in a strong acid medium. The color changes from light tan to dark-tan. Ketone: is based on the reaction of acetoacetic acid in urine with nitroprusside. The resulting color ranges from tan, when no reaction takes place, different purple shades for positive reactions. Specific Gravity: is based on the pKa change. In the presence of urinary cations, protons are released from a polyelectrolyte producing a color change in the bromothymol blue indicator from blue to yellow. Blood: is based on the pseudoperoxidase activity of hemoglobin, which catalyzes the reaction of 3,3',5,5'-tetramethylbencidine with buffered organic hydroperoxide. The resulting color ranges from greenish-yellow to greenish-blue and then to dark blue. pH: is based on a double indicators (methyl red and bromothymol blue), which gives a broad range of colors covering the entire urinary pH range. The colors range from orange to greenish-yellow and then to bluish-green. Protein: is based on the color change of the indicator, tetrabromophenol, in the presence of proteins. A positive reaction is indicated by a color change from greenish-yellow to green and then to dark-green. Urobilinogen: is based on the diazotization reaction of a diazonium salt and urinary urobilinogen in a strong acid medium. The color changes range from light-oink to dark reddish-pink. Nitrite: is based on the reaction of the p-arsanilic acid and nitrite, derived from a dietary nitrate in the presence of bacteria in urine, to form a diazonium compound. This compound reacts with N-(1-naphthyl)-ethylenediamine in an acidic medium. The resulting color is pink. Any degree of pink color is considered positive. Leukocytes: reveals the presence of granulocyte esterases. The esterases cleave a pyrazole ester derivative to release hydroxyrazol derivative. This derivative reacts with diazonium salt to produce a purple product. Ascorbic acid: is based on the reducing process of ascorbic acid. The composition comprises certain aromatic compound which is colored in its oxidized state but which becomes colorless when reduced by ascorbic acid. The color changes from dark-green to greenish-yellow. ## M. Performance Characteristics (if/when applicable): ### 1. Analytical performance: #### a. Precision/Reproducibility: Reproducibility testing was performed using 2 commercially available urine controls (negative and a positive). Within-run precision was performed in 20 replicates in one day with three lots and three operators. The between-run assayed both controls once a day for 20 days using three lots and three operators. The results were read by comparing color reactions to the color blocks on the canister label. Results are displayed in the table below: {5} | | Control Level I (negative) | | | Control Level II (positive) | | | | --- | --- | --- | --- | --- | --- | --- | | Analyte | Expected Results | Within-run Total Agreement | Between-day Total Agreement | Expected Results mg/dL | Within-run Total Agreement | Between-day Total Agreement | | Urobilinogen | 0.1 mg/dL | 58/60 (96.7%) | 56/60 (93%) | 2 | 57/60 (95%) | 53/60 (88.3%) | | Glucose | Negative | 60/60 (100%) | 58/60 (96.7%) | 500 | 56/60 (93.3%) | 56/60 (93.3%) | | Ketones | Negative | 57/60 (95%) | 54/60 (90%) | 15 | 57/60 (95%) | 55/60 (91.7%) | | Bilirubin | Negative | 56/60 (93%) | 55/60 (91.7%) | 3+ | 59/60 (98.3%) | 56/60 (93.3%) | | Proteins | Negative | 59/60 (98.3%) | 57/60 (95%) | 30 | 57/60 (95%) | 57/60 (95%) | | Nitrite | Negative | 60/60 (100%) | 60/60 (100%) | Positive | 57/60 (95%) | 56/60 (93.3%) | | pH | 6.0 | 56/60 (93%) | 53/60 (88.3%) | 7.0 | 56/60 (93.3%) | 52/60 (86.7%) | | Blood | Negative | 58/60 (96.7%) | 57/60 (95%) | 50 Ery/ul | 57/60 (95%) | 57/60 (95%) | | Specific Gravity | 1.020 | 56/60 (93.3%) | 53/60 (88.3%) | 1.010 | 57/60 (95%) | 55/60 (91.7%) | | Leukocytes | Negative | 58/60 (96.6%) | 57/60 (95%) | 25 Leu/ul | 57/60 (95%) | 56/60 (93.3%) | The urinalysis controls did not contain ascorbic acid; the sponsor used one ascorbic acid positive standard solution, which contained 20 mg/dL. Test was performed as above. | | Control Level I (negative) | | | Control Level II (positive) | | | | --- | --- | --- | --- | --- | --- | --- | | Analyte | Expected Results | Within-run Total Agreement | Between-day Total Agreement | Expected Results mg/dL | Within-run Total Agreement | Between-day Total Agreement | | Ascorbic Acid | Negative | 57/60 (95%) | 56/60 (93.3%) | 20 | 56/60 (93.3%) | 57/60 (95%) | Point-of-Care Precision Testing: Precision studies were performed at three POL sites with three operators typically found in these settings. Three lots of test strips were used (one at each site). Testing was performed using 2 commercially available urine controls (negative and a positive). The urinalysis controls did not contain {6} ascorbic acid; the sponsor used one ascorbic acid positive standard solution, which contained 20 mg/dL. Within-run precision was performed in 20 replicates in one day with three lots and three operators. The between-run assayed both controls once a day for 20 days. The results were read by comparing color reactions to the color blocks on the canister label. Results are displayed in the table below: | Control 1 (Negative) | | | | | | | | --- | --- | --- | --- | --- | --- | --- | | Analyte | Expected Results | | Site 1 Total Agreement | Site 2 Total Agreement | Site 3 Total Agreement | Combined Total Agreement | | Urobilinogen | 0.1 mg/dl | Within-run | 57/60 (95%) | 58/60 (96.7%) | 56/60 (93.3%) | 171/180 (95%) | | | | Between-run | 56/60 (93.3%) | 57/60 (95%) | 58/60 (96.7%) | 171/180 (95%) | | Glucose | Negative | Within-run | 59/60 (98.3%) | 58/60 (96.7%) | 57/60 (95%) | 174/180 (96.7%) | | | | Between-run | 58/60 (96.7%) | 57/60 (95%) | 57/60 (93.3%) | 172/180 (95.6%) | | Ketones | Negative | Within-run | 56/60 (93.3%) | 56/60 (93.3%) | 56/60 (93.3%) | 168/180 (93.3%) | | | | Between-run | 54/60 (90%) | 53/60 (88.3%) | 54/60 (90%) | 161/180 (89.4%) | | Bilirubin | Negative | Within-run | 57/60 (95%) | 56/60 (93.3%) | 56/60 (93.3%) | 169/180 (93.9%) | | | | Between-run | 55/60 (91.7%) | 56/60 (93.3%) | 54/60 (90%) | 165/180 (91.7%) | | Protein | Negative | Within-run | 58/60 (96.7%) | 57/60 (95%) | 57/60 (95%) | 172/180 (95.6%) | | | | Between-run | 57/60 (95%) | 56/60 (93.3%) | 55/60 (91.7%) | 168/180 (93.3%) | | Nitrite | Negative | Within-run | 60/60 (100%) | 59/60 (98.3%) | 58/60 (96.7%) | 177/180 (98.3%) | | | | Between-run | 60/60 (100%) | 58/60 (91.7%) | 57/60 (95%) | 175/180 (97.2%) | | pH | 6.0 | Within-run | 57/60 (95%) | 56/60 (93.3%) | 55/60 (91.7%) | 168/180 (93.3%) | | | | Between-run | 53/60 (88.3%) | 54/60 (90%) | 53/60 (88.3%) | 160/180 (88.9%) | | Blood | Negative | Within-run | 59/60 (98.3%) | 58/60 (96.7%) | 57/60 (95%) | 174/180 (96.7%) | | | | Between-run | 57/60 (95%) | 57/60 (95%) | 56/60 (93.3%) | 170/180 (94.4%) | | Specific | 1.020 | Within-run | 57/60 | 56/60 | 57/60 | 170/180 | {7} | Control 2 (Positive) | | | | | | | | --- | --- | --- | --- | --- | --- | --- | | Analyte | Expected Results | | Site 1 Total Agreement | Site 2 Total Agreement | Site 3 Total Agreement | Combined Total Agreement | | Urobilinogen | 2.0 mg/dl | Within-run | 56/60 (93.3%) | 57/60 (95%) | 57/60 (95%) | 170/180 (94.4%) | | | | Between-run | 53/60 (88.3%) | 54/60 (90%) | 55/60 (91.7%) | 162/180 (90%) | | Glucose | 500 mg/dL | Within-run | 57/60 (95%) | 56/60 (93.3%) | 57/60 (95%) | 170/180 (94.4%) | | | | Between-run | 56/60 (93.3%) | 56/60 (93.3%) | 57/60 (95%) | 169/180 (93.9%) | | Ketones | 15 mg/dL | Within-run | 57/60 (95%) | 57/60 (95%) | 58/60 (96.7%) | 172/180 (95.6%) | | | | Between-run | 55/60 (91.7%) | 56/60 (93.3%) | 55/60 (91.7%) | 166/180 (92.2%) | | Bilirubin | 3+ | Within-run | 57/60 (95%) | 58/60 (96.7%) | 57/60 (95%) | 172/180 (95.6%) | | | | Between-run | 56/60 (93.3%) | 56/60 (93.3%) | 55/60 (91.7%) | 167/180 (92.7%) | | Protein | 30 mg/dL | Within-run | 57/60 (95%) | 58/60 (96.7%) | 57/60 (95%) | 172/180 (95.6%) | | | | Between-run | 57/60 (95%) | 57/60 (95%) | 56/60 (93.3%) | 170/180 (94.4%) | | Nitrite | Positive | Within-run | 58/60 (96.7%) | 57/60 (95%) | 56/60 (93.3%) | 171/180 (95%) | | | | Between-run | 56/60 (93.3%) | 55/60 (91.7%) | 55/60 (91.7%) | 166/180 (92.2%) | | pH | 7.0 | Within-run | 56/60 (93.3%) | 56/60 (93.3%) | 56/60 (93.3%) | 168/180 (93.3%) | | | | Between-run | 52/60 (86.7%) | 54/60 (90%) | 54/60 (90%) | 160/180 (88.9%) | | Blood | 50 | Within-run | 56/60 | 57/60 | 56/60 | 169/180 | {8} 9 | | Ery/μL | | (93.3%) | (95%) | (93.3%) | (93.9%) | | --- | --- | --- | --- | --- | --- | --- | | | | Between-run | 57/60 (95%) | 56/60 (93.3%) | 55/60 (91.7%) | 168/180 (93.3%) | | Specific Gravity | 1.010 | Within-run | 56/60 (93.3%) | 56/60 (93.3%) | 56/60 (93.3%) | 168/180 (93.3%) | | | | Between-run | 55/60 (91.7%) | 55/60 (91.7%) | 55/60 (91.7%) | 165/180 (91.7%) | | Leukocytes | 25 Leu/μL | Within-run | 58/60 (96.7%) | 56/60 (93.3%) | 57/60 (95%) | 171/180 (95%) | | | | Between-run | 56/60 (93.3%) | 57/60 (95%) | 56/60 (93.3%) | 169/180 (93.9%) | | Ascorbic Acid | 20 mg/dL | Within-run | 57/60 (95%) | 56/60 (93.3%) | 58/60 (96.7%) | 171/180 (95%) | | | | Between-run | 57/60 (95%) | 58/60 (96.7%) | 56/60 (93.3%) | 171/180 (95%) | b. Linearity/assay reportable range: The range of the device was assessed by repeat testing with spiked urine samples containing known concentrations for each analyte. Test material was adjusted to match the mid-point of a concentration range for a particular color block on the strip. The samples were repeated in replicates of 10 with three test strip lots and three operators (one lot per operator). The results are obtained by the direct comparison of the reagent strip with the color blocks on the bottle label. The results are presented in the tables below: | Urobilinogen | Intended Concentrations (mg/dL) | | | | | | --- | --- | --- | --- | --- | --- | | Concentration reported (mg/dL) | 1 | 2 | 4 | 8 | 12 | | 12 | 0 | 0 | 0 | 1 | 30 | | 8 | 0 | 0 | 1 | 28 | 0 | | 4 | 0 | 2 | 28 | 1 | 0 | | 2 | 1 | 28 | 1 | 0 | 0 | | 1 | 27 | 0 | 0 | 0 | 0 | | 0.1 | 2 | 0 | 0 | 0 | 0 | | % Agreement | 90% | 93.3% | 93.3% | 93.3% | 100% | | Glucose | Intended Concentrations (mg/dL) | | | | | | --- | --- | --- | --- | --- | --- | | Concentration reported (mg/dL) | Negative | 100 | 250 | 500 | 1000 | | 1000 | 0 | 0 | 0 | 0 | 30 | | 500 | 0 | 0 | 0 | 28 | 0 | {9} | 250 | 0 | 0 | 29 | 2 | 0 | | --- | --- | --- | --- | --- | --- | | 100 | 0 | 29 | 1 | 0 | 0 | | Negative | 30 | 1 | 0 | 0 | 0 | | % Agreement | 100% | 96.7% | 96.7% | 93.3% | 100% | | Ketones | Intended Concentrations (mg/dL) | | | | | | --- | --- | --- | --- | --- | --- | | Concentration reported (mg/dL) | Negative | 5 | 15 | 40 | 80 | | 80 | 0 | 0 | 0 | 1 | 29 | | 40 | 0 | 0 | 0 | 29 | 1 | | 15 | 0 | 2 | 29 | 0 | 0 | | 5 | 1 | 28 | 1 | 0 | 0 | | Negative | 29 | 0 | 0 | 0 | 0 | | % Agreement | 96.7% | 93.3% | 96.7% | 96.7% | 96.7% | | Bilirubin | Intended Concentrations (mg/dL) | | | | | --- | --- | --- | --- | --- | | Concentration reported (mg/dL) | Negative | 1 | 2 | 3 | | 3 | 0 | 0 | 2 | 30 | | 2 | 0 | 1 | 28 | 0 | | 1 | 3 | 29 | 0 | 0 | | Negative | 27 | 0 | 0 | 0 | | % Agreement | 90% | 96.7% | 93.3% | 100% | | Protein | Intended Concentrations (mg/dL) | | | | | | | --- | --- | --- | --- | --- | --- | --- | | Concentration reported (mg/dL) | Negative | 15 | 30 | 100 | 300 | 1000 | | 1000 | 0 | 0 | 0 | 0 | 0 | 29 | | 300 | 0 | 0 | 0 | 0 | 30 | 1 | | 100 | 0 | 0 | 0 | 28 | 0 | 0 | | 30 | 0 | 2 | 29 | 2 | 0 | 0 | | 15 | 2 | 28 | 1 | 0 | 0 | 0 | | Negative | 28 | 0 | 0 | 0 | 0 | 0 | | % Agreement | 93.3% | 93.3% | 96.7% | 93.3% | 100% | 96.7% | {10} | Nitrite | Intended Concentrations (mg/dL) | | | --- | --- | --- | | Concentration reported (mg/dL) | Negative | Positive | | Positive | 0 | 30 | | Negative | 30 | 0 | | % Agreement | 100% | 100% | | pH | Intended Concentrations | | | | | | | --- | --- | --- | --- | --- | --- | --- | | Concentration reported (mg/dL) | 5 | 6 | 6.5 | 7 | 8 | 9 | | 9 | 0 | 0 | 0 | 0 | 0 | 30 | | 8 | 0 | 0 | 0 | 0 | 29 | 0 | | 7 | 0 | 0 | 3 | 29 | 1 | 0 | | 6.5 | 0 | 0 | 27 | 1 | 0 | 0 | | 6 | 0 | 28 | 0 | 0 | 0 | 0 | | 5 | 30 | 2 | 0 | 0 | 0 | 0 | | % Agreement | 100% | 93.3% | 90% | 96.7% | 96.7% | 100% | | Hemolyzed Blood | Intended Concentrations (Ery/μl) | | | | | | --- | --- | --- | --- | --- | --- | | Concentration reported (Ery/μl) | Negative | 7 | 25 | 50 | 250 | | 250 | 0 | 0 | 0 | 0 | 30 | | 50 | 0 | 0 | 0 | 29 | 0 | | 25 | 0 | 0 | 30 | 1 | 0 | | 7 | 0 | 29 | 0 | 0 | 0 | | Negative | 30 | 1 | 0 | 0 | 0 | | % Agreement | 100% | 96.7% | 100% | 96.7% | 100% | | Non hemolyzed blood | Intended Concentrations (Ery/μl) | | | | --- | --- | --- | --- | | Concentration reported (Ery/μl) | Negative | 10 | 50 | | 50 | 0 | 2 | 29 | | 10 | 1 | 28 | 1 | | Negative | 29 | 0 | 0 | | % Agreement | 96.7% | 93.3% | 96.7% | {11} | Specific Gravity | Intended Concentrations g/mL | | | | | | | | --- | --- | --- | --- | --- | --- | --- | --- | | Concentration reported (g/mL) | 1.000 | 1.005 | 1.010 | 1.015 | 1.020 | 1.025 | 1.030 | | 1.030 | 0 | 0 | 0 | 0 | 0 | 0 | 30 | | 1.025 | 0 | 0 | 0 | 0 | 2 | 29 | 0 | | 1.020 | 0 | 0 | 0 | 0 | 28 | 1 | 0 | | 1.015 | 0 | 0 | 0 | 29 | 0 | 0 | 0 | | 1.010 | 0 | 2 | 29 | 1 | 0 | 0 | 0 | | 1.005 | 0 | 28 | 1 | 0 | 0 | 0 | 0 | | 1.000 | 30 | 0 | 0 | 0 | 0 | 0 | 0 | | % Agreement | 100% | 93.3% | 96.7% | 96.7% | 93.3% | 96.7% | 100% | | Leukocytes | Intended Concentrations (Leu/μl) | | | | | | --- | --- | --- | --- | --- | --- | | Concentration reported (Leu/μl) | Negative | 5 | 18 | 75 | 500 | | 500 | 0 | 0 | 0 | 0 | 30 | | 75 | 0 | 0 | 0 | 29 | 0 | | 18 | 0 | 1 | 28 | 1 | 0 | | 5 | 2 | 27 | 2 | 0 | 0 | | Negative | 28 | 2 | 0 | 0 | 0 | | % Agreement | 93.3% | 90% | 93.3% | 96.7% | 100% | | Ascorbic Acid | Intended Concentrations (mg/dL) | | | | | --- | --- | --- | --- | --- | | Concentration reported (mg/dL) | Negative | 10 | 20 | 40 | | 40 | 0 | 0 | 0 | 29 | | 20 | 0 | 1 | 30 | 1 | | 10 | 0 | 29 | 0 | 0 | | Negative | 30 | 0 | 0 | 0 | | % Agreement | 100% | 96.7% | 100% | 96.7% | c. Traceability, Stability, Expected values (controls, calibrators, or methods): No information on traceability was provided. Real time stability studies have been conducted. Protocols and acceptance criteria were described and found to be acceptable. When stored at $2 - 30^{\circ}\mathrm{C}$ the assay reagent is good until the expiration date 18 months. {12} d. Detection limit: The sensitivity of the assay was validated by spiking negative/normal urine samples to known concentrations for each analyte (70% of the cut-off, 100% of the cut-off and 130% of the cut-off). The samples we repeated in replicates of 20 with three test strip lots and three operators (one lot per operator) in one day. The results are obtained by the direct comparison of the reagent strip with the color blocks on the bottle label. The results are presented in the tables below: | UROBILINOGEN | | | | | --- | --- | --- | --- | | Sample | 70% Cut-off | 100% Cut-off | 130% Cut-off | | Concentration | 0.7 mg/dL | 1 mg/dL | 1.3 mg/dL | | Negative Results | 31 | 6 | 1 | | Positive Results | 29 | 54 | 59 | | Percentage of positive | 48.3% | 90% | 98.3% | | GLUCOSE | | | | | --- | --- | --- | --- | | Sample | 70% Cut-off | 100% Cut-off | 130% Cut-off | | Concentration | 70 mg/dL | 100 mg/dL | 130 mg/dL | | Negative Results | 18 | 2 | 0 | | Positive Results | 42 | 58 | 60 | | Percentage of positive | 70.0% | 96.7% | 100% | | KETONES | | | | | Sample | 70% Cut-off | 100% Cut-off | 130% Cut-off | | Concentration | 3.5 mg/dL | 5 mg/dL | 6.5 mg/dL | | Negative Results | 14 | 1 | 1 | | Positive Results | 46 | 59 | 59 | | Percentage of positive | 76.7% | 98.3% | 98.3% | | BILIRUBIN | | | | | Sample | 70% Cut-off | 100% Cut-off | 130% Cut-off | | Concentration | 0.35 mg/dL | 0.5 mg/dL | 0.65 mg/dL | | Negative Results | 12 | 2 | 0 | | Positive Results | 48 | 58 | 60 | | Percentage of positive | 80.0% | 96.7% | 100% | | PROTEINS | | | | | Sample | 70% Cut-off | 100% Cut-off | 130% Cut-off | | Concentration | 10.5 mg/dL | 15 mg/dL | 19.5 mg/dL | | Negative Results | 20 | 1 | 1 | | Positive Results | 40 | 59 | 59 | | Percentage of positive | 66.7% | 98.3% | 98.3% | {13} 14 | NITRITE | | | | | --- | --- | --- | --- | | Sample | 70% Cut-off | 100% Cut-off | 130% Cut-off | | Concentration | 0.035 mg/dL | 0.05 mg/dL | 0.065 mg/dL | | Negative Results | 28 | 5 | 1 | | Positive Results | 32 | 55 | 59 | | Percentage of positive | 53.3% | 91.7% | 98.3% | | HEMOGLOBIN | | | | | Sample | 70% Cut-off | 100% Cut-off | 130% Cut-off | | Concentration | 0.0105 mg/dL | 0.015 mg/dL | 0.0195 mg/dL | | Negative Results | 22 | 4 | 1 | | Positive Results | 38 | 56 | 59 | | Percentage of positive | 63.3% | 93.3% | 98.3% | | NON HEMOLIZED ERYTROCYTES | | | | | Sample | 70% Cut-off | 100% Cut-off | 130% Cut-off | | Concentration | 7 Ery/μL | 10 Ery/μL | 13 Ery/μL | | Negative Results | 19 | 1 | 0 | | Positive Results | 41 | 59 | 60 | | Percentage of positive | 68.3% | 98.3% | 100% | | LEUKOCYTES | | | | | Sample | 70% Cut-off | 100% Cut-off | 130% Cut-off | | Concentration | 7 Leu/μL | 10 Leu/μL | 13 Leu/μL | | Negative Results | 24 | 3 | 0 | | Positive Results | 36 | 57 | 60 | | Percentage of positive | 60.0% | 95.0% | 100% | | ASCORBIC ACID | | | | | Sample | 70% Cut-off | 100% Cut-off | 130% Cut-off | | Concentration | 7 mg/dL | 10 mg/dL | 13 mg/dL | | Negative Results | 22 | 1 | 0 | | Positive Results | 38 | 59 | 60 | | Percentage of positive | 63.3% | 98.3% | 100% | e. Analytical specificity: Urine samples with known analyte concentration were spiked with possible interfering substances to various concentrations. The samples we repeated in replicates of 3. The results are obtained by the direct comparison of the reagent strip with the color blocks on the bottle label. The results are presented in the tables below: | Analyte | Interfering Substance | Impact on Test | | --- | --- | --- | | Urobilinogen | p-Aminosalicilic Acid (≤ 500 mg/dL) | Do not interfere | | | Nitrite (> 2.5 mg/dL) | False negative results | | | Formol (> 0.2 mL/dL) | False negative results | {14} | Glucose | Specific Gravity (≥1.020) | Falsely decreased results | | --- | --- | --- | | | pH > 8 | Falsely decreased results | | | Ascorbic Acid (≥25 mg/dL) | False negative results | | | Ketones (>40 mg/dL) | Falsely decreased results | | Ketones | Specific Gravity (≤1.030) | Do not interfere | | | pH (5 - 9) | Do not interfere | | Bilirubin | Ascorbic Acid (≤ 100 mg/dL) | Do not interfere | | | Light exposure (400 lux - ≥ 3 hours) | Falsely decreased results | | Protein | Specific Gravity (≥1.020) | Falsely increased results | | | pH (> 8) | Falsely increased results | | Nitrite | Ascorbic Acid (≥ 50 mg/dL) | False negative results | | | Specific Gravity (>1.020) | Falsely decreased results | | | pH (≥ 8) | Falsely decreased results | | pH | Cross-contamination by adjacent reagent pads | Do not interfere | | | Bacterial Contamination | Increasing Results | | Blood | Ascorbic Acid (≥ 50 mg/dL) | False negative results | | | Proteins (≥ 50 mg/dL) | False negative results | | | Specific Gravity (≥1.020) | Falsely increased results | | | pH (≥8) | Falsely decreased results | | | Sodium Hypochlorite (≥ 300 ppm) | False positive results | | Specific Gravity | Proteins (≥ 300 mg/dL) | Falsely increased results | | | pH (≥ 8) | Falsely decreased results | | | Glucose (≤ 4000 mg/dL) | Do not interfere | | Leukocytes | Glucose (≥ 3000 mg/dL) | Falsely decreased results | | | Proteins (≥ 500 mg/dL) | Falsely decreased results | | | Formol (≥ 0.2 mL/dL) | False positive results | | | Oxalic Acid (≥ 200 mg/dL) | Falsely decreased results | | | Specific Gravity (≥1.025) | Falsely decreased results | | | pH (≥ 8) | Falsely decreased results | f. Assay cut-off: Not applicable for devices of this type. See detection limit section M.1.d above 2. Comparison studies: a. Method comparison with predicate device: Patient samples were tested in Point of Care settings by nine operators (three per site) on both the Wiener lab Urine strip and Bayer Multistix 10SG and the {15} Clinistrip URS 11 for the ascorbic acid. Additionally, some spiked samples were used to help cover the range of each analyte. The results are presented in the tables below: Urobilinogen: | Bayer Multistix 10 SG | ≥8 mg/dL | 4 mg/dL | 2 mg/dl | 1 mg/dL | Normal | | --- | --- | --- | --- | --- | --- | | Weiner Lab Strip | | | | | | | 12 mg/dL | 8 | 0 | 0 | 0 | 0 | | 8 | 14 | 3 | 0 | 0 | 0 | | 4 | 2 | 14 | 2 | 0 | 0 | | 2 | 0 | 4 | 15 | 5 | 0 | | 1 | 0 | 0 | 4 | 33 | 10 | | Normal | 0 | 0 | 1 | 15 | 605 | | Total | 24 | 21 | 22 | 53 | 615 | | % Agreement (Exactly Match) | 91.6% | 66.7% | 68.2% | 62.3% | 98.4% | | % Agreement (±1 Color Block) | 100% | 100% | 95.6% | 100% | 100% | {16} Glucose: | Bayer Multistix 10 SG | ≥2,000 mg/dL | 1000 mg/dL | 500 mg/dL | 250 mg/dL | 100 mg/dL | 0 (Neg) | | --- | --- | --- | --- | --- | --- | --- | | Weiner Lab Strip | | | | | | | | 1,000 mg/dL | 12 | 19 | 3 | 0 | 0 | 0 | | 500 | 0 | 3 | 22 | 3 | 2 | 0 | | 250 | 0 | 0 | 5 | 18 | 5 | 1 | | 100 | 0 | 0 | 2 | 5 | 31 | 10 | | 0 (Neg) | 0 | 0 | 0 | 1** | 18* | 575 | | Total | 12 | 22 | 32 | 27 | 56 | 586 | | % Agreement (Exactly Match) | 100% | 86% | 69% | 66.7% | 55.4% | 98.1% | | % Agreement (±1 Color Block) | 100% | 100% | 94% | 96.3% | 96.4% | 99.8% | * 13 of the 18 negative results had other interferents present (5 with ascorbic acid &gt; 24, 3 with ketones &gt;40 and 5 with pH &gt;8) that may affect glucose. ** pH &gt;7. Ketone: | Bayer Multistix 10 SG | 80 mg/dL | 40 mg/dl | 15 mg/dL | 5 mg/dL | 0 (Neg) | | --- | --- | --- | --- | --- | --- | | Weiner Lab Strip | | | | | | | 80 mg/dL | 40 | 5 | 0 | 0 | 0 | | 40 | 2 | 29 | 6 | 1 | 0 | | 15 | 0 | 3 | 31 | 13 | 2 | | 5 | 0 | 1 | 1 | 45 | 6 | | 0 (Neg) | 0 | 0 | 2 | 13 | 535 | | Total | 42 | 38 | 40 | 72 | 543 | | % Agreement (Exactly Match) | 95.2% | 76.3% | 77.5% | 62.5% | 98.5% | | % Agreement (±1 Color Block) | 100% | 97.4 | 95% | 98.6% | 99.6% | Bilirubin: | Bayer Multistix 10 SG | 3 mg/dL (+++) | 2 mg/dL (++) | 1 mg/dL (+) | 0 (Neg) | | --- | --- | --- | --- | --- | | Weiner Lab Strip | | | | | | +++ 3 mg/dL | 17 | 7 | 1 | 0 | | ++ 2 mg/dL | 4 | 24 | 6 | 0 | | + 1 mg/dL | 0 | 3 | 35 | 9 | | 0 (Neg) | 0 | 0 | 6 | 623 | | Total | 21 | 34 | 48 | 632 | | % Agreement (Exactly Match) | 80.1% | 70.6% | 72.9% | 98.6% | | % Agreement (±1 Color Block) | 100% | 100% | 97.9% | 100% | {17} 18 Block) Protein: | Bayer Multistix 10 SG | ≥2000 mg/dL | 300 mg/dL | 100 mg/dL | 30 mg/dL | 15 mg/dL | 0 (Neg) | | --- | --- | --- | --- | --- | --- | --- | | Weiner Lab Strip | | | | | | | | 1000 mg/dL | 15 | 5 | 0 | 0 | 0 | 0 | | 300 | 3 | 18 | 2 | 0 | 0 | 0 | | 100 | 1 | 4 | 16 | 3 | 0 | 0 | | 30 | 0 | 0 | 5 | 28 | 6 | 1 | | 15 | 0 | 0 | 0 | 2 | 41 | 6 | | 0 (Neg) | 0 | 0 | 0 | 0 | 4 | 575 | | Total | 19 | 27 | 23 | 33 | 51 | 582 | | % Agreement (Exactly Match) | 78.9% | 66.7% | 69.6% | 84.8% | 80.4% | 98.8% | | % Agreement (±1 Color Block) | 94.7% | 100% | 100% | 100% | 100% | 99.8% | Nitrite: | Bayer Multistix 10 SG | Positive | Negative | | --- | --- | --- | | Weiner Lab Strip | | | | Positive | 9 | 122 | | Negative | 584 | 20 | | Total | 593 | 142 | | % Agreement (Exactly Match) | 93% | 97% | | % Agreement (±1 Color Block) | 100% | 100% | pH: | Bayer Multistix 10 SG | 8.5 | 8.0 | 7.5 | 7.0 | 6.5 | 6.0 | 5.0 | | --- | --- | --- | --- | --- | --- | --- | --- | | Weiner Lab Strip | | | | | | | | | 9.0 | 112 | 5 | 2 | 0 | 0 | 0 | 0 | | 8.0 | 11 | 108 | 9 | 2 | 0 | 0 | 0 | | 7.0 | 0 | 6 | 11 | 89 | 8 | 3 | 0 | | 6.5 | 0 | 0 | 0 | 5 | 109 | 2 | 1 | | 6.0 | 0 | 0 | 0 | 0 | 5 | 115 | 9 | | 5.0 | 0 | 0 | 0 | 0 | 1 | 10 | 112 | | Total | 123 | 119 | 22 | 96 | 123 | 130 | 122 | | % Agreement | 91.1% | 90.8% | 50% | 92.7% | 88.6% | 88.5% | 91.8% | {18} 19 | (Exactly Match) | | | | | | | | | --- | --- | --- | --- | --- | --- | --- | --- | | % Agreement (±1 Color Block) | 100% | 100% | 90.9% | 100% | 99.2% | 97.7% | 99.2% | Blood: | Bayer Multistix 10 SG | 200 ery/μL | 80 ery/μL | 25 ery/μL | 10 ery/μL | 0 (Neg) | | --- | --- | --- | --- | --- | --- | | Weiner Lab Strip | | | | | | | 250 ery/μL | 39 | 2 | 1 | 0 | 0 | | 50 | 3 | 51 | 5 | 0 | 0 | | 25 | 0 | 5 | 47 | 7 | 0 | | 10 | 0 | 0 | 12 | 60 | 9 | | 0 (Neg) | 0 | 0 | 0 | 3 | 491 | | Total | 42 | 58 | 65 | 70 | 500 | | % Agreement (Exactly Match) | 92.9% | 87.9% | 72.3% | 85.7% | 98.2% | | % Agreement (±1 Color Block) | 100% | 100% | 98.5% | 100% | 100% | SG: | Bayer Multistix 10 SG | 1.030 | 1.025 | 1.020 | 1.015 | 1.010 | 1.005 | 1.000 | | --- | --- | --- | --- | --- | --- | --- | --- | | Weiner Lab Strip | | | | | | | | | 1.030 | 56 | 5 | 2 | 0 | 0 | 0 | 0 | | 1.025 | 7 | 80 | 4 | 0 | 0 | 0 | 0 | | 1.020 | 1 | 4 | 93 | 4 | 0 | 0 | 0 | | 1.015 | 0 | 0 | 10 | 84 | 7 | 3 | 0 | | 1.010 | 0 | 0 | 2 | 4 | 109 | 11 | 0 | | 1.005 | 0 | 0 | 0 | 2 | 14 | 131 | 22 | | 1000 | 0 | 0 | 0 | 0 | 0 | 12 | 68 | | Total | 64 | 89 | 111 | 94 | 130 | 157 | 90 | | % Agreement (Exactly Match) | 87.5% | 89.9% | 83.8% | 89.4% | 83.8% | 83.4% | 75.5% | | % Agreement (±1 Color Block) | 98.4% | 100% | 96.4% | 97.9% | 100% | 98.1% | 100% | Leukocyte: | Bayer Multistix 10 SG | 500 leu/μL | 125 leu/μL | 70 leu/μL | 15 leu/μL | 0 (Neg) | | --- | --- | --- | --- | --- | --- | | Weiner Lab Strip | | | | | | | 500 leu/μL | 47 | 6 | 0 | 0 | 0 | | 75 | 5 | 55 | 75 | 5 | 0 | {19} | 25 | 0 | 5 | 8 | 42 | 2 | | --- | --- | --- | --- | --- | --- | | 10 | 0 | 0 | 0 | 31 | 7 | | 0 (Neg) | 0 | 0 | 0 | 5 | 442 | | Total | 52 | 66 | 83 | 83 | 451 | | % Agreement (Exactly Match) | 90.4% | 86% | 90.4% | 37% | 98.0% | | % Agreement (±1 Color Block) | 100% | 100% | 100% | 94% | 99.6% | Ascorbic Acid: | Teco Diagnostics Clinistrip | 40 mg/dL | 20 mg/dL | 10 mg/dL | Negative | | --- | --- | --- | --- | --- | | Weiner Lab Strip | | | | | | 50 mg/dL | 45 | 5 | 0 | 0 | | 20 | 5 | 76 | 3 | 0 | | 10 | 1 | 3 | 69 | 5 | | Negative | 0 | 1 | 7 | 515 | | Total | 51 | 85 | 79 | 520 | | % Agreement (Exactly Match) | 88% | 89% | 87% | 99% | | % Agreement (±1 Color Block) | 98% | 99% | 100% | 100% | b. Matrix comparison: Not applicable. The device is only intended for measurements with 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 {20} 4. Clinical cut-off: Not applicable 5. Expected values/Reference range: In the labeling the sponsor includes information about expected values from literature. References include the following: Free, A.H. and Free, H.M. Urinalysis, clinical discipline of clinical science, CRC, Crit. Rev. Clin. Lab. Sc. 3/4: 481, 1972 Graff, L – A handbook of routine urinalysis, Philadelphia, J.B. Lippincott Co., 1983 Kark, R. et.al. – A primer of urinalysis, 2nd ed. N.Y., Harper and Row; 1963. N. Proposed Labeling: The labeling is sufficient and it satisfies the requirements of 21 CFR Part 809.10. O. Conclusion: The submitted information in this premarket notification is complete and supports a substantial equivalence decision. 21