URITEST 10G & 11G URINE REAGENT STRIPS AND URITEST-50 AND URITEST-500B URINE ANALYZERS

{0} 1 # 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY AND INSTRUMENT COMBINATION TEMPLATE A. 510(k) Number: k082811 B. Purpose for Submission: New device C. Measurand: Urine pH, blood, glucose, protein, ketone, urobilinogen, bilirubin, specific gravity, nitrite, ascorbic acid and leukocytes D. Type of Test: Qualitative and semi-quantitative E. Applicant: Urit Medical Electronic Co., Ltd. F. Proprietary and Established Names: Uritest 10G Urine Reagent Strips, Uritest 11G Urine Reagent Strips, Uritest 50 Urine Analyzer, Uritest -500B Urine Analyzer G. Regulatory Information: | Classification Name | Product Code | Device Class | Regulation Number | | --- | --- | --- | --- | | Occult blood test | JIO | II | 21 CFR §864.6550 | | Urinary glucose (non-quantitative) test system | JIL | II | 21 CFR §862.1340 | | Urinary urobilinogen (non-quantitative) test system | CDM | I | 21 CFR §862.1785 | | Urinary bilirubin and its conjugates (non-quantitative) test system | JJB | I | 21 CFR §862.1115 | | Ketones (non-quantitative) test system | JIN | I | 21 CFR §862.1435 | {1} | Urinary protein or albumin (non-quantitative) test system | JIR | I | 21 CFR §862.1645 | | --- | --- | --- | --- | | Nitrite (non-quantitative) test system | JMT | I | 21 CFR §862.1510 | | Leukocyte peroxidase test | LJX | I | 21 CFR §864.7675 | | Urinary pH (non-quantitative) test system | CEN | I | 21 CFR §862.1550 | | Ascorbic acid test system | JMA | I | 21 CFR §862.1095 | | Specific Gravity | KSL | I | 21 CFR §864.9320 | | Automated Urinalysis System | KQO | I | 21 CFR §862.2900 | 4. Panel: (75) Clinical Chemistry, (81) Hematology H. Intended Use: 1. Intended use(s): See indications for use below. 2. Indication(s) for use: The Uritest-50 and Uritest-500B urine analyzers are semi-automated, bench top instruments which are intended for prescription, in vitro diagnostic use only. The instruments perform semi-quantitative detection of the following analytes in urine: leukocytes, ketone, nitrite, urobilinogen, bilirubin, protein, glucose, specific gravity, blood, pH and ascorbic acid. Test results may provide information regarding the status of carbohydrate metabolism, kidney and liver function, acid-base balance and bacteriuria. The instruments use the accompanying check strip for daily calibration. Uritest 10G urine reagent strips provide semi-quantitative tests for leukocytes, ketone, nitrite, urobilinogen, bilirubin, protein, glucose, specific gravity, blood and pH in urine. The Uritest 10G urine reagent strips are for use with the Uritest-50 urine analyzer and are for prescription, in vitro diagnostic use only. Test results may provide information regarding the status of carbohydrate metabolism, kidney and liver function, acid-base balance and bacteriuria. Uritest 11G urine reagent strips provide semi-quantitative tests for leukocytes, ketone, nitrite, urobilinogen, bilirubin, protein, glucose, specific gravity, blood, pH and ascorbic acid in urine. The Uritest 11G urine reagent strips are for use with Uritest-500B urine analyzer and are for prescription, in vitro diagnostic use only. Test results may provide information regarding the status of carbohydrate metabolism, kidney and liver function, acid-base balance and bacteriuria. {2} 3. Special conditions for use statement(s): Prescription use only The test strips are not to be used for visual reading. 4. Special instrument requirements: Uritest 50 and Uritest 500B urine analyzers I. Device Description: The Uritest-50 and Uritest-500B Urine Chemistry Analyzers are reflectance spectrophotometers that measure the reflectance from a Uritest 10G or Uritest 11G urine reagent strip for urinalysis. Both devices can display and print urinalysis results and can be connected to a laboratory computer for data management. Both analyzers are capable of reading the ascorbic acid pad on the Uritest 11G strip. Uritest 10G strips and the Uritest 11G are dry chemistry reagent strips for use in urine. Both strips measure urine glucose, pH, urobilinogen, bilirubin, protein, specific gravity, ketone, blood, leukocyte esterase and nitrite. The Uritest 11G can also measure ascorbic acid. J. Substantial Equivalence Information: | Device Name | Predicate Device Name | Predicate 510(k) number | | --- | --- | --- | | Uritest 50 | Bayer Clinitek 500 | k926359 | | Uritest 500B | Bayer Clinitek 500 | k926359 | | Uritest 10 G | Bayer Multistix 10 SG | k052719 | | Uritest 11G | Bayer Multistix 10 SG | k052719 | | Uritest 11G (ascorbic acid) | Diuri Uristik H-11 | k040703 | | Uritest 50 (ascorbic acid) | Diuri H-500 | k040703 | | Uritest 500B (ascorbic acid) | Diuri H-500 | k040703 | 3. Comparison with predicate: | Item | Device | Predicate k926359 | Predicate k040703 (ascorbic acid only) | | --- | --- | --- | --- | | | Uritest-50 | Bayer Clinitek 500 | Dirui H-500 | | Intended use | For use with Uritest 10G and 11G urine reagent strips for the semi-quantitative determination of Leukocytes, Ketones, Nitrite, | For use with Bayer Multistix 10 SG reagent strips for the semi-quantitative determination of | For use with URISTK H-11 reagent strips for the qualitative or semi-quantitative determination of | {3} | | Urobilinogen, Bilirubin, Protein, Glucose, Specific Gravity, Blood, pH and Ascorbic Acid. | Leukocytes, Ketones, Nitrite, Urobilinogen, Bilirubin, Protein, Glucose, Specific Gravity, Blood and pH. | Urobilinogen, Bilirubin, Ketone (acetoacetic acid), Blood, Protein, Nitrite, Leukocytes, Glucose, Specific Gravity, pH, and Ascorbic Acid. | | --- | --- | --- | --- | | General design | Bench-top instrument | Same | Same | | Operating principle | Reflectance photometer | Same | Same | | Calibration | Self-calibration---white calibration bar | Same | Same | | Specimen ID enter | Manually enter or by bar code reader | Same | Same | | Printer | Internal or external | Same | Same | | Throughput | Single test mode: 60 tests/hour Continuous test mode: 120 tests/hour | 500 tests/hour | 514 strips/hour | | Result report | Semi-quantitative symbol, SI or Conventional unit and plus system | Same | Same | | Memory | 1,000 results | 500 patient results 200 control results | 2000 patient results | | Environment requirement | 15°C-30°C, RH ≤ 80% | 18°C -30°C, RH: 20% - 80% | 18°C -30°C, RH ≤ 80% | | Weight | 2 Kg | 7.4 Kg | 6.8 Kg | | Dimension | 290 mm X 200 mm X 100 mm | 324 mm X 377 mm X 282 mm | 380 mm X 378 mm X 275 mm | | Power source | DC 12V (Adapter), AC100-240V, 50/60Hz Power dissipation: 30VA | 100-240VAC ±10%, 50-60Hz. Input: 72VA | 100~240VAC, 50Hz/60Hz Power: 40VA | | Item | Device | Predicate k926359 | Predicate k040703 (ascorbic acid only) | | --- | --- | --- | --- | | | Uritest-500B | Bayer Clinitek 500 | Dirui H-500 | | Intended use | For use with Uritest 10G and 11G urine reagent strips for the semi-quantitative determination of Leukocytes, Ketones, Nitrite, Urobilinogen, Bilirubin, Protein, Glucose, Specific Gravity, Blood, pH and | For use with Bayer Multistix 10 SG reagent strips for the semi-quantitative determination of Leukocytes, Ketones, Nitrite, Urobilinogen, Bilirubin, Protein, | For use with URISTK H-11 reagent strips for the qualitative or semi-quantitative determination of Urobilinogen, Bilirubin, Ketone (acetoacetic acid), Blood, Protein, Nitrite, | {4} 5 | | Ascorbic Acid. | Glucose, Specific Gravity, Blood and pH. | Leukocytes, Glucose, Specific Gravity, pH, and Ascorbic Acid. | | --- | --- | --- | --- | | Design | Bench-top instrument | Same | Same | | Operating principle | Reflectance photometer | Same | Same | | Calibration | Self-calibration---white calibration bar | Same | Same | | Specimen ID enter | Manually enter or by bar code reader | Same | Same | | Printer | Internal or external | Same | Same | | Throughput | 500 tests/hour | 500 tests/hour | 514 strips/hour | | Result report | Semi-quantitative symbol, SI or Conventional unit | Same | Same | | Memory | 1,000 results | 500 patient results 200 control results | 2000 patient results | | Environment requirement | 15°C-30°C, RH ≤ 80% | 18°C -30°C, RH: 20% - 80% | 18°C -30°C, RH ≤ 80% | | Weight | 6.5 Kg | 7.4 Kg | 6.8 Kg | | Dimension | 390 mm X 340 mm X 290 mm | 324 mm X 377 mm X 282 mm | 380 mm X 378 mm X 275 mm | | Power source | AC100-240V, 50/60Hz Input: 61VA | 100-240VAC ±10%, 50-60Hz. Input: 72VA | 100~240VAC, 50Hz/60Hz Power: 40VA | ## Reagent Strips | Item | | Predicate k052719 | Predicate k040703 (ascorbic acid only) | | --- | --- | --- | --- | | | Uritest 11G | Bayer Multistix 10SG | Dirui URISTIK H-11 | | Intended use | For semi-quantitative determination of certain constituents in urine by reflectance photometry with Uritest-50 or Uritest-500B Urine Analyzer. These measurements are useful in the evaluation of renal, urinary and metabolic disorders. | For semi-qualitative determination of certain constituents in urine either visually or by reflectance photometry with the Clinitek family Urine Analyzer. These measurements are useful in the evaluation of renal, urinary and metabolic disorders. | For qualitative and semi-qualitative determination of certain constituents in urine either visually or by reflectance photometry with the Dirui H-100 and H-500 Urine Analyzers. These measurements are useful in the evaluation of renal, urinary and metabolic disorders. | | Analytes | Leukocytes, Ketones, Nitrite, Urobilinogen, | Leukocytes, Ketones, Nitrite, Urobilinogen, | Leukocytes, Ketones, Nitrite, Urobilinogen, | {5} 6 | | Bilirubin, Protein, Glucose, Specific Gravity, Blood, pH and Ascorbic acid | Bilirubin, Protein, Glucose, Specific Gravity, Blood and pH | Bilirubin, Protein, Glucose, Specific Gravity, Blood, pH and Ascorbic acid | | --- | --- | --- | --- | | Specimen | Urine | Same | Same | | Architecture | Firm plastic, dry reagent strips | Same | Same | | Test principle | Ingredients that change color in reaction with analytes | Same | Same | | Storage | Store at 2°C-30°C | At temperatures below 30°C do not freeze. | At temperatures below 30°C do not freeze. | | -Item | | Predicate k052719 | | --- | --- | --- | | | Uritest 10G | Bayer Multistix 10 SG | | Intended use | For semi-quantitative determination of certain constituents in urine by reflectance photometry with Uritest-50 or Uritest-500B Urine Analyzer. These measurements are useful in the evaluation of renal, urinary and metabolic disorders. | For semi-qualitative determination of certain constituents in urine either visually or by reflectance photometry with the Clinitek family Urine Analyzer. These measurements are useful in the evaluation of renal, urinary and metabolic disorders. | | Analytes | Leukocytes, Ketones, Nitrite, Urobilinogen, Bilirubin, Protein, Glucose, Specific Gravity, Blood, and pH | Leukocytes, Ketones, Nitrite, Urobilinogen, Bilirubin, Protein, Glucose, Specific Gravity, Blood and pH | | Specimen | Urine | Same | | Architecture | Firm plastic, dry reagent strips | Same | | Test principle | Ingredients that change color in reaction with analytes | Same | | Storage | Store at 2°C-30°C | At temperatures below 30°C do not freeze. | K. Standard/Guidance Document Referenced (if applicable): EN 61000-3-2:2000+A2:A2005 Harmonic Current Test EN 61000-3-3:1995+A1:2001, Voltage Fluctuations and Flicker Test EN 61010-1:2001, Safety Requirements for Electrical Equipment for Measurement, Control, and Laboratory Use Part 1: General Requirements {6} 7 L. Test Principle: Uritest 50 and Uritest 500B The Uritest 50 and Uritest 500B utilize reflectance photometry to measure the concentration of various urine chemical compounds and constituents. A urine wetted reagent strip is placed into the instrument(s) causing a color change in the test pads. The degree of color development on the pads is proportional to the concentration of the urine analyte. The strip passes under a LED light source. As the pad darkens in color, more light is absorbed and less is reflected. The reflected light is filtered at specific wavelengths corresponding to the reflected colors on the test pads. It is converted by the optical-electronic sensor system into electrical signals which are then converted into concentration units and printed. Uritest 10G and Uritest 11G Test Strips Leukocytes: The test reveals the presence of granulocyte esterases. These esterases cleave an indoxyl ester, and the indoxyl so liberated reacts with a diazonium salt to produce a violet dye. Leukocyte esterase results may be positive in the absence of observable cells if the leukocytes have lysed. Positive results may occasionally be found with random specimens from females due to contamination of the specimen by vaginal discharge. Elevated glucose concentrations (1000-2000mg/dL) or high specific gravity may cause decreased test results. The presence of cephalexin, cephalothin, tetracycline may cause decreased reactivity, and high levels of the drug may cause a false negative reaction. Reactivity may also vary with temperature. The test area does not react with lymphocyte. Ketone: This test is based on the principle of Legal’s test and is more sensitive to acetoacetic acid than to acetone. The reagent area does not react with $\beta$-hydroxybutyric acid. Some high specific gravity/low pH urines may give reactions up to and including Trace. Normal urine specimens usually yield negative results with this reagent. False positive results (Trace) may occur with highly pigmented urine specimens or those containing large amounts or levodopa metabolites. Nitrite: The test is based on the principle of Griess’s test and is specific to nitrite. Any degree of uniform pink colour development should be interpreted as a positive. Nitrite test area reacts singularly to the nitrite. Reacting color density does not correlate to number of existing bacteria. A negative result does not in itself prove that there is no significant bacteria. Negative results may occur when urinary tract infections are cause by organisms which do not contain reductase to convert nitrate to nitrite; when urine has not been retained in the bladder long enough (4-8hrs) for reduction of nitrate to occur; or when dietary nitrate is absent, even if organisms containing reductase are present and bladder incubation is ample. Ascorbic acid concentrations of $25\mathrm{mg/dL}$ or greater may cause false negative results with specimens containing nitrite ion concentrations of $0.4\mathrm{mg/dL}$ or less. Urobilinogen: This test is based on the Ehrlich reaction. The reagent area may react with interfering substances known to react with Ehrlich’s reagent. Excreted pigments and medicaments that have a red intrinsic coloration in acidic medium may produce false positive results. This test is inhibited by elevated concentrations of formaldehyde. Strip reactivity increases with temperature increasing; the optimum temperature is $22^{\circ}\mathrm{C}$ to $26^{\circ}\mathrm{C}$. The absence of urobilinogen cannot be determined with this {7} test. **Bilirubin:** This test is based on the coupling of bilirubin with diazonium salt in an acid medium. Normally no bilirubin is detectable in urine by even the most sensitive methods. Even trace amounts of bilirubin are sufficiently abnormal to require further investigation. Some urine constituents (medicines, urinary indicants) may produce a yellowish or reddish discoloration of the test paper that may interfere with interpreting the result. Ascorbic acid concentrations of 100mg/dL or greater may cause false negatives. **Protein:** The test is based on the principle of the protein error of a pH indicator. The reagent area is more sensitive to albumin. An elevated pH (up to 9) may affect the test. The residues of disinfectants containing quaternary ammonium groups or chlorohexidine are present in the urine vessel maybe lead to a false positive result. **Glucose:** The test is based on the specific glucose oxidase/peroxidase reaction. The test is specific for glucose, no substance excreted in urine other than glucose is known to give a positive result. Ascorbic acid of more than 45mg/dL and/or high Ketone concentrations (80mg/dL) may cause false negatives for specimens containing small amounts of glucose (100mg/dL). The reactivity of the glucose test decreases as the SG of the urine increases. False positive reactions may be caused by hypochlorite or peroxide (cleaning agents). Reactivity may also vary with temperature. **Specific Gravity:** This test contains a detergent and Bromthymol blue that indicates the presence of ionic constituents in the urine by changing color from green to yellow. The specific gravity test permits determination of urine specific gravity between 1.005 and 1.030. In general, it correlates within 0.005 with values obtained with the refractive index method. Strips are automatically adjusted for pH by the instrument when pH≥7.0 or pH≤5.0. Highly buffered alkaline urine may cause low readings relative to other methods. Elevated specific gravity readings may be obtained in the presence of moderate quantities (500mg/dL) of protein. **Blood:** Hemoglobin and myoglobin catalyze the oxidation of the indicator by means of organic hydroperoxide contained in the test paper. This test is highly sensitive to hemoglobin and thus complements microscopic examination. The sensitivity of this test may be reduced in urine with high specific gravity. The test is equally sensitive to myoglobin as to hemoglobin. Captopril and Lodine may also cause decreased reactivity. Blood is often found in the urine of menstruating females. Certain oxidizing contaminants, such as hypochlorite, may produce false positive results. Microbial peroxidase associated with urinary tract infection may cause a false positive reaction. Ascorbic acid concentrations greater than 25mg/dL may cause false negatives at the trace levels. **pH:** This test contains a mixed indicator which assures a marked change in colour between pH4.5 and pH9. **Ascorbic Acid (Uritest 11G only):** The test involves the decolorization of Tillman’s reagent. False positive results may occur. ## M. Performance Characteristics (if/when applicable): 1. **Analytical performance:** a. **Precision/Reproducibility:** {8} Repeatability (within run) precision of both analyzers was evaluated by using negative urines and spiked urines of known concentrations for each analyte. Each sample was tested 20 times across 3 instruments with the Uritest 10G or Uritest 11G strips for a total of 60 measurements at each concentration. All concentrations for all tests had 60 of 60 (100%) match at ± one color block. Uritest 50 | Test | Expected Value | | | | | | | --- | --- | --- | --- | --- | --- | --- | | Leukocyte (leu/mcL) | - (0) | ± (15) | +1 (70) | +2 (125) | +3 (500) | | | Exact agreement | 60/60 | 60/60 | 54/60 | 60/60 | 60/60 | | | ± 1 color block | 60/60 | 60/60 | 60/60 | 60/60 | 60/60 | | | Nitrite | Negative | Positive | | | | | | Exact agreement | 60/60 | 60/60 | | | | | | ± 1 color block | 60/60 | 60/60 | | | | | | Ketone (mg/dL) | - (0) | ± (5) | +1 (15) | +2 (40) | +3 (≥ 80) | | | Exact agreement | 60/60 | 52/60 | 60/60 | 50/60 | 52/60 | | | ± 1 color block | 60/60 | 60/60 | 60/60 | 60/60 | 60/60 | | | Blood (ery/mcL) | - (0) | ± (10) | +1 (25) | +2 (80) | +3 (200) | | | Exact agreement | 60/60 | 60/60 | 60/60 | 60/60 | 52/60 | | | ± 1 color block | 60/60 | 60/60 | 60/60 | 60/60 | 60/60 | | | Bilirubin (mg/dL) | - (0) | +1 (0.5) | +2 (2) | +3 (6) | | | | Exact agreement | 60/60 | 56/60 | 60/60 | 54/60 | | | | ± 1 color block | 60/60 | 60/60 | 60/60 | 60/60 | | | | Urobilinogen (EU/dL) | Normal | +1 (2.0) | +2 (4.0) | +3(≥ 8.0) | | | | Exact agreement | 60/60 | 60/60 | 54/60 | 60/60 | | | | ± 1 color block | 60/60 | 60/60 | 60/60 | 60/60 | | | | Protein (mg/dL) | - (0) | ± (15) | +1 (30) | +2 (100) | +3 (300) | | | Exact agreement | 60/60 | 58/60 | 60/60 | 60/60 | 39/60 | | | ± 1 color block | 60/60 | 60/60 | 60/60 | 60/60 | 60/60 | | | Glucose (mg/dL) | - (0) | ± (50) | +1 (100) | +2(250) | +3(500) | +4(≥ 1000) | | Exact agreement | 60/60 | 52/60 | 60/60 | 48/60 | 60/60 | 60/60 | | ± 1 color block | 60/60 | 60/60 | 60/60 | 60/60 | 60/60 | 60/60 | | Specific Gravity | 1.005 | 1.010 | 1.015 | 1.020 | 1.025 | 1.030 | | % Exact agreement | 60/60 | 53/60 | 60/60 | 52/60 | 40/60 | 60/60 | | % ± 1 color block | 60/60 | 60/60 | 60/60 | 60/60 | 60/60 | 60/60 | | pH | 5.0 | 6.0 | 7.0 | 8.0 | 8.5 | 9.0 | | Exact agreement | 48/60 | 34/60 | 24/60 | 60/60 | 42/60 | 100 | | ± 1 color block | 60/60 | 60/60 | 60/60 | 60/60 | 60/60 | 60/60 | | Ascorbic Acid (mg/dL) | - (0) | ± (10) | +1 (25) | +2 (50) | +3 (100) | | | Exact agreement | 60/60 | 58/60 | 60/60 | 60/60 | 52/60 | | | ± 1 color block | 60/60 | 60/60 | 60/60 | 60/60 | 60/60 | | {9} Uritest—500B | Test | Expected Value | | | | | | | --- | --- | --- | --- | --- | --- | --- | | Leukocyte (leu/mcL) | - (0) | ± (15) | +1 (70) | +2 (125) | +3 (500) | | | Exact agreement | 60/60 | 60/60 | 54/60 | 56/60 | 60/60 | | | ± 1 color block | 60/60 | 60/60 | 60/60 | 60/60 | 60/60 | | | Nitrite | Negative | Positive | | | | | | Exact agreement | 60/60 | 60/60 | | | | | | ± 1 color block | 60/60 | 60/60 | | | | | | Ketone (mg/dL) | - (0) | ± (5) | +1 (15) | +2 (40) | +3 (≥ 80) | | | Exact agreement | 60/60 | 50/60 | 60/60 | 48/60 | 58/60 | | | ± 1 color block | 60/60 | 60/60 | 60/60 | 60/60 | 60/60 | | | Blood (ery/mcL) | - (0) | ± (10) | +1 (25) | +2 (80) | +3 (200) | | | Exact agreement | 60/60 | 57/60 | 60/60 | 60/60 | 59/60 | | | ± 1 color block | 60/60 | 60/60 | 60/60 | 60/60 | 60/60 | | | Bilirubin (mg/dL) | - (0) | +1 (0.5) | +2 (2) | +3 (6) | | | | Exact agreement | 60/60 | 60/60 | 60/60 | 54/60 | | | | ± 1 color block | 60/60 | 60/60 | 60/60 | 60/60 | | | | Urobilinogen (EU/dL) | Normal | +1 (2.0) | +2 (4.0) | +3(≥ 8.0) | | | | Exact agreement | 60/60 | 58/60 | 60/60 | 60/60 | | | | ± 1 color block | 60/60 | 60/60 | 60/60 | 60/60 | | | | Protein (mg/dL) | - (0) | ± (15) | +1 (30) | +2 (100) | +3 (300) | | | Exact agreement | 60/60 | 60/60 | 60/60 | 60/60 | 45/60 | | | ± 1 color block | 60/60 | 60/60 | 60/60 | 60/60 | 60/60 | | | Glucose (mg/dL) | - (0) | ± (50) | +1 (100) | +2(250) | +3(500) | +4(≥ 1000) | | Exact agreement | 60/60 | 60/60 | 60/60 | 44/60 | 60/60 | 60/60 | | ± 1 color block | 60/60 | 60/60 | 60/60 | 60/60 | 60/60 | 60/60 | | Specific Gravity | 1.005 | 1.010 | 1.015 | 1.020 | 1.025 | 1.030 | | Exact agreement | 60/60 | 48/60 | 60/60 | 58/60 | 45/60 | 60/60 | | ± 1 color block | 60/60 | 60/60 | 60/60 | 60/60 | 60/60 | 60/60 | | pH | 5.0 | 6.0 | 7.0 | 8.0 | 8.5 | 9.0 | | Exact agreement | 42/60 | 60/60 | 58/60 | 60/60 | 34/60 | 60/60 | | ± 1 color block | 60/60 | 60/60 | 60/60 | 60/60 | 60/60 | 60/60 | | Ascorbic Acid (mg/dL) | - (0) | ± (10) | +1 (25) | +2 (50) | +3 (100) | | | Exact agreement | 60/60 | 60/60 | 60/60 | 60/60 | 56/60 | | | ± 1 color block | 60/60 | 60/60 | 60/60 | 60/60 | 60/60 | | Precision was determined using two levels of commercially available control material. One lot each of Uritest 10G and Uritest 11G strips was used on one Uritest-50 and Uritest-500B. Tests were performed in replicates of 10 for 2 runs on each analyzer for 10 days. {10} Uritest-50 N=negative, P=positive | | Level 1 | | | | Level 2 | | | | | --- | --- | --- | --- | --- | --- | --- | --- | --- | | Analyte | Expected values | Test results | % Agreement | n | Expected values | Test results | % Agreement | N | | Leukocytes | N | N | 100 | 400 | ±-2+ | ±-1+ | 100 | 400 | | Ketone | N | N | 100 | 400 | ±-2+ | 1+ | 100 | 400 | | Nitrite | N | N | 100 | 400 | P | P | 100 | 400 | | Urobilinogen | N | N | 100 | 400 | 2+-3+ | 2+-3+ | 100 | 400 | | Bilirubin | N | N | 100 | 400 | 2+-3+ | 3+ | 100 | 400 | | Protein | N | N | 100 | 400 | 2+-3+ | 3+ | 100 | 400 | | Glucose | N | N | 100 | 400 | 2+-4+ | 3+-4+ | 100 | 400 | | Specific Gravity | 1.010-1.020 | 1.010-1.015 | 100 | 400 | 1.015-1.025 | 1.015-1.025 | 100 | 400 | | Blood | N | N | 100 | 400 | 2+-3+ | 3+ | 100 | 400 | | pH | 5.0-6.0 | 5.5-6.0 | 100 | 400 | 6.5-7.5 | 6.5-7.0 | 100 | 400 | Uritest-500B N=negative, P=positive | | Level 1 | | | | Level 2 | | | | | --- | --- | --- | --- | --- | --- | --- | --- | --- | | Analyte | Expected values | Test results | % Agreement | n | Expected values | Test results | % Agreement | N | | Leukocytes | N | N | 100 | 400 | ±-2+ | ±-1+ | 100 | 400 | | Ketone | N | N | 100 | 400 | ±-2+ | 1+ | 100 | 400 | | Nitrite | N | N | 100 | 400 | P | P | 100 | 400 | | Urobilinogen | N | N | 100 | 400 | 2+-3+ | 2+-3+ | 100 | 400 | | Bilirubin | N | N | 100 | 400 | 2+-3+ | 3+ | 100 | 400 | | Protein | N | N | 100 | 400 | 2+-3+ | 3+ | 100 | 400 | | Glucose | N | N | 100 | 400 | 2+-4+ | 3+-4+ | 100 | 400 | | Specific Gravity | 1.010-1.020 | 1.010-1.015 | 100 | 400 | 1.015-1.025 | 1.015-1.025 | 100 | 400 | | Blood | N | N | 100 | 400 | 2+-3+ | 3+ | 100 | 400 | | pH | 5.0-6.0 | 5.5-6.0 | 100 | 400 | 6.5-7.5 | 6.5-7.0 | 100 | 400 | | Ascorbic Acid | N | N | 100 | 400 | N | N | 100 | 400 | ## b. Linearity/assay reportable range: A study was performed to test the measuring range on the Uritest 50 analyzer and Uritest 500 analyzer using one lot of Uritest 10G and Uritest 11G strips in replicates of 10. Samples were created by spiking negative urine with known concentrations of each substance or by serial dilution of a high concentration with a negative urine. Specimens were adjusted the match the concentration for each particular color pad on {11} the strip. Negative samples were not tested. See section M.1.a. Repeatability studies for negative samples. Results are summarized below. Uritest-50 with Uritest 10G | Test | Exact Match | % | ±1 Color Block | % | | --- | --- | --- | --- | --- | | pH | 37/50 | 74 | 50/50 | 100 | | Glucose | 38/50 | 88 | 50/50 | 100 | | Specific Gravity | 56/60 | 93 | 60/60 | 100 | | Nitrite | 10/10 | 100 | 10/10 | 100 | | Blood | 34/40 | 85 | 40/40 | 100 | | Protein | 37/40 | 93 | 40/40 | 100 | | Bilirubin | 28/30 | 93 | 30/30 | 100 | | Urobilinogen | 26/30 | 87 | 30/30 | 100 | | Ketone | 37/40 | 93 | 40/40 | 100 | | Leukocyte esterase | 37/40 | 93 | 40/40 | 100 | | Ascorbic acid (11G) | 35/40 | 88 | 40/40 | 100 | Uritest-500B with Uritest 11G | Test | Exact Match | % | ±1 Color Block | % | | --- | --- | --- | --- | --- | | pH | 31/50 | 62 | 50/50 | 100 | | Glucose | 38/50 | 88 | 50/50 | 100 | | Specific Gravity | 54/60 | 88 | 60/60 | 100 | | Nitrite | 10/10 | 100 | 10/10 | 100 | | Blood | 34/40 | 85 | 40/40 | 100 | | Protein | 39/40 | 98 | 40/40 | 100 | | Bilirubin | 29/30 | 97 | 30/30 | 100 | | Urobilinogen | 27/30 | 90 | 30/30 | 100 | | Ketone | 40/40 | 100 | 40/40 | 100 | | Leukocyte esterase | 33/40 | 83 | 40/40 | 100 | | Ascorbic acid | 33/40 | 83 | 40/40 | 100 | The reportable ranges for the Uritest -50 and Uritest-500B are: | Test | Reportable Range | | --- | --- | | pH | 5.0-9.0 | | Glucose | Neg.-1000 mg/dL | | Specific Gravity | 1.005-1.030 | | Nitrite | Neg-Pos | | Blood | Neg-200 ery/micL | | Protein | Neg-300 mg/dL | | Bilirubin | Neg-6 mg/dL | | Urobilinogen | 2-8 E.U/dL | | Ketone | Neg-80 mg/dL | | Leukocyte esterase | Neg-500 leu/micL | | Ascorbic acid | Neg -100 mg/dL | {12} c. Traceability, Stability, Expected values (controls, calibrators, or methods): The sponsor recommends using commercially available control materials for use on the Uritest 50 and Uritest-500B urine analyzers. Calibration verification is performed using Check Strips which are included with the analyzers. These are white strips which check the remittance values for each test. Recommendations for calibration verification are included in the operator's manual for each analyzer. Real time stability studies were performed for the Uritest 10G and Uritest 11G test strips over a 21 month period. The test strips were stored at $2^{\circ}\mathrm{C} - 8^{\circ}\mathrm{C}$ and $30^{\circ}\mathrm{C}$ . Strips were tested quarterly with negative and spiked positive urine samples on the Uritest 50 and Uritest 500 Urine Analyzers. Data demonstrated that the test strips met the sponsor's claimed shelf-life of 18 months at $2^{\circ}\mathrm{C} - 30^{\circ}\mathrm{C}$ and $&lt;= 80\%$ Relative Humidity. d. Detection limit: Analytical sensitivities of the Uritest 10G and Uritest 11G strips on the Uritest 50 and Uritest-500B were evaluated by spiking urine with known concentrations of each analyte and then diluting these samples with a negative urine to establish the range where the strip went from negative readings to positive readings. Each concentration was tested 10 times on each analyzer using each strip type. The upper limit of sensitivity was defined as the cutoff at which $100\%$ of the test results were trace or positive. The sensitivities for both analyzers and both strips were identical. pH and specific gravity do not have lower limits of sensitivity. See section M.1.b. | Analyte | 10G | | 11G | | Sensitivity range | | --- | --- | --- | --- | --- | --- | | Leukocytes | Lowest sensitivity 15 leu/mcL | Highest sensitivity 40 leu/mcL | Lowest sensitivity 15 leu/mcL | Highest sensitivity 40 leu/mcL | 15-40 leu/mcL | | Uritest 50 Negative | 2 | 0 | 3 | 0 | | | Trace (15 cells/mcL) | 8 | 10 | 7 | 10 | | | Uritest 500B Negative | 3 | 0 | 3 | 0 | | | Trace (15 cells/mcL) | 7 | 10 | 7 | 10 | | | Ketone | Lowest sensitivity 5 mg/dL | Highest sensitivity 10 mg/dL | Lowest sensitivity 5 mg/dL | Highest sensitivity 10 mg/dL | 5.0-10.0 mg/dL | | Uritest 50 Negative | 2 | 0 | 2 | 0 | | | Trace (5 mg/dL) | 8 | 10 | 8 | 10 | | | Uritest 500B Negative | 1 | 0 | 1 | 0 | | | Trace (5 mg/dL) | 9 | 10 | 9 | 10 | | {13} | Nitrites | Lowest sensitivity 0.15 mg/dL | Highest sensitivity 0.2 mg/dL | Lowest sensitivity 0.15 mg/dL | Highest sensitivity 0.2 mg/dL | 0.15-0.2 mg/dL (Neg/Pos) | | --- | --- | --- | --- | --- | --- | | Uritest 50 Negative | 1 | 0 | 2 | 0 | | | Positive | 9 | 10 | 8 | 10 | | | Uritest 500B Negative | 2 | 0 | 2 | 0 | | | Positive | 8 | 10 | 8 | 10 | | | Urobilinogen | Lowest sensitivity 1.0 EU/dL | Highest sensitivity 2.0 EU/dL | Lowest sensitivity 1.0 EU/dL | Highest sensitivity 2.0 EU/dL | 1.5-2.0 EU/dL | | Uritest 50 Negative | 3 | 0 | 3 | 0 | | | 1+ (2 EU/dL) | 7 | 10 | 7 | 10 | | | Uritest 500B Negative | 2 | 0 | 3 | 0 | | | 1+ (2 EU/dL) | 8 | 10 | 7 | 10 | | | Analyte | 10G | | 11G | | Sensitivity range | | --- | --- | --- | --- | --- | --- | | Bilirubin | Lowest sensitivity 0.5 mg/dL | Highest sensitivity 1.0 mg/dL | Lowest sensitivity 0.5 mg/dL | Highest sensitivity 1.0 mg/dL | 0.5-1.0 mg/dL | | Uritest 50 Negative | 3 | 0 | 3 | 0 | | | 1+ (0.5 mg/dL) | 7 | 10 | 7 | 10 | | | Uritest 500B Negative | 5 | 0 | 4 | 0 | | | 1+ (0.5 mg/dL) | 5 | 10 | 6 | 10 | | | Blood | Lowest sensitivity 5 Ery/mcL | Highest sensitivity 15 Ery/mcL | Lowest sensitivity 5 Ery/mcL | Highest sensitivity 15 Ery/mcL | 5-15 Ery/mcL | | Uritest 50 Negative | 2 | 0 | 2 | 0 | | | Trace (10 ery/micL) | 8 | 10 | 8 | 10 | | | Uritest 500B Negative | 1 | 0 | 2 | 0 | | | Trace (10 ery/micL) | 9 | 10 | 8 | 10 | | | Protein | Lowest sensitivity 10 mg/dL | Highest sensitivity 30 mg/dL | Lowest sensitivity 10 mg/dL | Highest sensitivity 30 mg/dL | 10-30 mg/dL | | Uritest 50 Negative | 7 | 0 | 8 | 0 | | | Trace (15 mg/dL) | 3 | 10 | 2 | 10 | | | Uritest 500B Negative | 8 | 0 | 8 | 0 | | | Trace (15 mg/dL) | 2 | 10 | 2 | 10 | | | Glucose | Lowest sensitivity 40 mg/dL | Highest sensitivity 50 mg/dL | Lowest sensitivity 40 mg/dL | Highest sensitivity 50 mg/dL | 40-50 mg/dL | | Uritest 50 Negative | 2 | 0 | 2 | 0 | | | Trace (50 mg/dL) | 8 | 10 | 8 | 10 | | | Uritest 500B Negative | 1 | 0 | 2 | 0 | | | Trace (50 mg/dL) | 9 | 10 | 8 | 10 | | {14} 15 | Ascorbic Acid | | Lowest sensitivity 10 mg/dL | Highest sensitivity 14 mg/dL | 10-14 mg/dL | | --- | --- | --- | --- | --- | | Uritest 50 Negative | | 5 | 0 | | | Trace (10 mg/dL) | | 5 | 10 | | | Uritest 500B Negative | | 4 | 0 | | | Trace (10 mg/dL) | | 6 | 10 | | e. Analytical specificity: Fresh negative urine was spiked with possible interfering substances at various interferent concentrations and analyzed in replicates of 10 using the Uritest 10G and 11G strips on the Uritest 50 and Uritest 500B analyzers. The concentration where interference is observed and its effect on various tests is summarized below: | Test | Interfering substances | Impact on test | | --- | --- | --- | | Leukocytes | Elevated glucose(1000-2000 mg/dL) | Lower reported leu/uL | | | High specific gravity (>1.025) | Lower reported leu/uL | | | Low temperature(<20℃) | Lower reported leu/uL | | Ketone | Levodopa metabolites | False positive (Trace) | | Nitrite | Ascorbic acid(>25mg/dL) | False negative | | Urobilinogen | Excreted pigment | False positive | | Bilirubin | Ascorbic acid(>100mg/dL) | False negative | | Protein | Elevated pH (up to 9) | False positive | | | Quaternary ammonium | False positive | | Glucose | Ascorbic acid (>45mg/dL) | False negative | | | High Ketone (80mg/dL) | False negative | | | Peroxide | False positive | | Specific gravity | Elevated protein (>500mg/dL) | High specific gravity | | Blood | Ascorbic acid(>25mg/dL) | False negatives | | | Microbial peroxidase | False positive | | pH | Bacterial contamination/overgrowth may cause elevated pH | False increase | | Ascorbic acid | Other reducing agents, specifically sodium thiosulfate, cysteine | False positive | Interfering substances and their effects on the various reagent strip analytes are presented in the labeling. {15} f. Assay cut-off: Not applicable ## 2. Comparison studies: a. Method comparison with predicate device: The clinical study was performed at three different clinical sites over 10 days. Three intended users operated the devices at each site (n=9). 321 out-patients were enrolled in the study: 104 subjects at Site 1, 102 subjects at Site 2 and 115 subjects at Site 3. The users used the labeling to perform the testing. The sponsor also used 19 spiked urine samples in the study (N=340). 5 spiked samples at the Site 1, 9 spiked samples at the Site 2 and 5 spiked samples at Site 3. Among these samples, about 25%~35% positive samples were covered for each analyte with majority of values at the cutoff. Both subject urine samples and spiked urine samples at each clinical site were tested both on Uritest 10G, Uritest 11G and Bayer Multistix 10SG using the respective urine analyzer for each system. The comparisons were as follows with the following note below: Glucose has different test pad concentrations between the candidate devices and the predicate devices. The differences are summarized below: | Glucose (mg/dL) | | - | ± | 1+ | 2+ | 3+ | 4+ | | --- | --- | --- | --- | --- | --- | --- | --- | | | Bayer | 0 | 100 | 250 | 500 | 1000 | --- | | | Uritest | 0 | 50 | 100 | 250 | 500 | 1000 | In addition, the sponsor performed ascorbic acid comparisons between the Uritest 50 and the Uritest 500B against the Dirui H-500 Urine Analyzer (k040703) on 216 samples at three sites using three intended users per site. The site combined results are below: 1) Uritest-50 with Uritest 11G VS. Dirui H-500 | | Ascorbic Acid | Predicate device | | | | | | --- | --- | --- | --- | --- | --- | --- | | | | -(0) | ±(10) | 1+(25) | 2+(50) | 3+(100) | | Proposed device | 3+(100) | | | | 1 | 12 | | | 2+(50) | | 1 | 2 | 13 | | | | 1+(25) | | 1 | 16 | 2 | | | | ±(10) | 1 | 20 | 1 | | | | | -(0) | 144 | 2 | | | | | Total | | 145 | 24 | 19 | 16 | 12 | | % Agreement (exact match) | | 99 | 83 | 84 | 81 | 100 | | % Agreement (±1 color block) | | 100 | 96 | 100 | 100 | 100 | {16} 2) Uritest-500B with Uritest 11G VS. Dirui H-500 | | Ascorbic Acid | Predicate device | | | | | | --- | --- | --- | --- | --- | --- | --- | | | | −(0) | ±(10) | 1+(25) | 2+(50) | 3+(100) | | Proposed device | 3+(100) | | | 1 | 1 | 12 | | | 2+(50) | | | 1 | 13 | | | | 1+(25) | | 2 | 16 | 2 | | | | ±(10) | 1 | 21 | 1 | | | | | −(0) | 144 | 1 | | | | | Total | | 145 | 24 | 19 | 16 | 12 | | % Agreement (exact match) | | 99 | 88 | 84 | 81 | 100 | | % Agreement (±1 color block) | | 100 | 100 | 95 | 100 | 100 | 3). Uritest-50 with Uritest 10G VS. Clinitek 500 with Multistix 10SG | | LEU | Predicate device | | | | | | --- | --- | --- | --- | --- | --- | --- | | | | − | ± | +1 | +2 | +3 | | Proposed device | +3 | | | | 1 | 16 | | | +2 | | | 6 | 13 | 1 | | | +1 | | 4 | 22 | 1 | | | | ± | 1 | 34 | 3 | | | | | − | 236 | 2 | | | | | Total | | 237 | 40 | 31 | 15 | 17 | | % Agreement (exact match) | | 99 | 85 | 71 | 87 | 94 | | % Agreement (±1 color block) | | 100 | 100 | 100 | 100 | 100 | | | NIT | Predicate device | | | --- | --- | --- | --- | | | | − | + | | Proposed device | + | | 91 | | | − | 248 | 1 | | Total | | 248 | 92 | | % Agreement (exact match) | | 100 | 99 | | % Agreement (±1 color block) | | 100 | 100 | {17} 18 | | KET | Predicate device | | | | | | --- | --- | --- | --- | --- | --- | --- | | | | — | ± | +1 | +2 | +3 | | Proposed device | +3 | | | | | 11 | | | +2 | | | 1 | 9 | | | | +1 | | | 17 | 3 | | | | ± | | 49 | 2 | | | | | — | 247 | 1 | | | | | Total | | 247 | 50 | 20 | 12 | 11 | | % Agreement (exact match) | | 100 | 98 | 85 | 75 | 100 | | % Agreement (±1 color block) | | 100 | 100 | 100 | 100 | 100 | For occult blood, test results were: | | BLD | Predicate device | | | | | | --- | --- | --- | --- | --- | --- | --- | | | | — | ± | +1 | +2 | +3 | | Proposed device | +3 | | | | | 19 | | | +2 | | | | 18 | 3 | | | +1 | | | 17 | 5 | 1 | | | ± | | 39 | 5 | | | | | — | 220 | 12 | 1 | | | | Total | | 220 | 51 | 23 | 23 | 23 | | % Agreement (exact match) | | 100 | 76 | 74 | 78 | 83 | | % Agreement (±1 color block) | | 100 | 100 | 96 | 100 | 96 | | | BIL | Predicate device | | | | | --- | --- | --- | --- | --- | --- | | | | — | +1 | +2 | +3 | | Proposed device | +3 | | | | 12 | | | +2 | | | 19 | 1 | | | +1 | | 51 | 1 | | | | — | 252 | 4 | | | | Total | | 252 | 55 | 20 | 13 | | % Agreement (exact match) | | 100 | 93 | 95 | 92 | | % Agreement (±1 color block) | | 100 | 100 | 100 | 100 | {18} | | URO | Predicate device | | | | | --- | --- | --- | --- | --- | --- | | | | Normal (0.2/1.0) | +1 (2.0) | +2 (4.0) | +3 (≥8.0) | | Proposed device | +3 | | | | 11 | | | +2 | | 1 | 24 | | | | +1 | | 51 | | | | | Normal | 250 | 3 | | | | Total | | 250 | 55 | 24 | 11 | | % Agreement (exact match) | | 100 | 93 | 100 | 100 | | % Agreement (±1 color block) | | 100 | 100 | 100 | 100 | | | PRO | Predicate device | | | | | | --- | --- | --- | --- | --- | --- | --- | | | | - | ± | +1 | +2 | +3 | | Proposed device | +3 | | | | | 15 | | | +2 | | | | 15 | | | | +1 | | | 16 | 4 | | | | ± | | 46 | 3 | 2 | | | | - | 232 | 6 | 1 | | | | Total | | 232 | 52 | 20 | 21 | 15 | | % Agreement (exact match) | | 100 | 88 | 80 | 71 | 100 | | % Agreement (±1 color block) | | 100 | 100 | 95 | 90 | 100 | | | GLU | Predicate device (mg/dl) | | | | | | --- | --- | --- | --- | --- | --- | --- | | | | - | ± (100) | +1 (250) | +2 (500) | +3 (1000) | | Proposed device (mg/dl) | +4 (1000) | | | | | 13 | | | +3 (500) | | | | 13 | 3 | | | +2 (250) | | 1 | 15 | 2 | | | | +1 (100) | | 31 | 1 | | | | | ± (50) | | 6 | | | | | | - | 255 | | | | | | Total | | 255 | 38 | 16 | 15 | 16 | | % Agreement (exact match) | | 100 | 82 | 94 | 87 | 81 | | % Agreement (±1 color block) | | 100 | 100 | 100 | 100 | 100 | {19} 20 | | SG | Predicate device | | | | | | | --- | --- | --- | --- | --- | --- | --- | --- | | | | 1.005 | 1.010 | 1.015 | 1.020 | 1.025 | 1.030 | | Proposed device | 1.030 | | | | | 4 | 42 | | | 1.025 | | | 1 | 1 | 58 | 6 | | | 1.020 | | | 10 | 71 | 7 | | | | 1.015 | | 4 | 41 | 21 | | | | | 1.010 | 4 | 45 | 2 | 2 | | | | | 1.005 | 15 | 6 | | | | | | Total | | 19 | 55 | 54 | 95 | 69 | 48 | | % Agreement (exact match) | | 79 | 82 | 76 | 75 | 84 | 88 | | % Agreement (±1 color block) | | 100 | 100 | 98 | 98 | 100 | 100 | | | pH | Predicate device | | | | | | | | | | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | | | | 5.0 | 5.5 | 6.0 | 6.5 | 7.0 | 7.5 | 8.0 | 8.5 | 9.0 | | Proposed device | 9.0 | | | | | | | | | 4 | | | 8.5 | | | | | | | | 5 | | | | 8.0 | | | | | | 1 | 6 | | | | | 7.5 | | | | | 4 | 12 | | | | | | 7.0 | | | | 3 | 32 | 4 | | | | | | 6.5 | | | 2 | 32 | 7 | | | | | | | 6.0 | | | 143 | 15 | 1 | | | | | | | 5.5 | 4 | 20 | 27 | | | | | | | | | 5.0 | 13 | 4 | 1 | | | | | | | | Total | | 17 | 24 | 173 | 50 | 44 | 17 | 6 | 5 | 4 | | % Agreement (exact match) | | 76 | 83 | 83 | 64 | 73 | 71 | 100 | 100 | 100 | | % Agreement (±1 color block) | | 100 | 100 | 99 | 100 | 99 | 100 | 100 | 100 | 100 | 4). Uritest-500B with Uritest 11G VS. Clinitek 500 with Multistix 10SG | | LEU | Predicate device | | | | | | --- | --- | --- | --- | --- | --- | --- | | | | - | ± | +1 | +2 | +3 | | Proposed device | +3 | | | | | 16 | | | +2 | | | 2 | 15 | 1 | | | +1 | | 3 | 24 | | | | | ± | 1 | 35 | 5 | | | | | - | 236 | 2 | | | | | Total | | 237 | 40 | 31 | 15 | 17 | | % Agreement (exact | | 99 | 88 | 77 | 100 | 94 | {20} For occult blood, test results were: | | BLD | Predicate device | | | | | --- | --- | --- | --- | --- | --- | | | | - | ± | +1 | +2 | | Proposed device | +3 | | | | 20 | | | +2 | | | 19 | 2 | | | +1 | | 1 | 18 | 3 | | | ± | | 43 | 4 | 1 | | - | | 220 | 7 | 1 | | | Total | | 220 | 51 | 23 | 23 | | % Agreement (exact match) | | 100 | 84 | 78 | 83 | | % Agreement (±1 color block) | | 100 | 100 | 96 | 96 | {21} | | BIL | Predicate device | | | | | --- | --- | --- | --- | --- | --- | | | | - | +1 | +2 | +3 | | Proposed device | +3 | | | | 13 | | | +2 | | | 19 | | | | +1 | 1 | 54 | 1 | | | | - | 251 | 1 | | | | Total | | 252 | 55 | 20 | 13 | | % Agreement (exact match) | | 99 | 98 | 95 | 100 | | % Agreement (±1 color block) | | 100 | 100 | 100 | 100 | | | URO | Predicate device | | | | | --- | --- | --- | --- | --- | --- | | | | Normal (0.2/1.0) | +1 (2.0) | +2 (4.0) | +3 (>=8.0) | | Proposed device | +3 | | | | 11 | | | +2 | | | 22 | | | | +1 | 1 | 51 | 2 | | | | Normal | 249 | 4 | | | | Total | | 250 | 55 | 24 | 11 | | % Agreement (exact match) | | 99 | 93 | 92 | 100 | | % Agreement (±1 color block) | | 100 | 100 | 100 | 100 | | | PRO | Predicate device | | | | | | --- | --- | --- | --- | --- | --- | --- | | | | - | ± | +1 | +2 | +3 | | Proposed device | +3 | | | | | 15 | | | +2 | | | | 16 | | | | +1 | | 1 | 16 | 3 | | | | ± | | 44 | 3 | 2 | | | | - | 232 | 7 | 1 | | | | Total | | 232 | 52 | 20 | 21 | 15 | | % Agreement (exact match) | | 100 | 85 | 80 | 76 | 100 | | % Agreement (±1 color block) | | 100 | 100 | 95 | 90 | 100 | {22} | | GLU | Predicate device (mg/dl) | | | | | | --- | --- | --- | --- | --- | --- | --- | | | | - | ± (100) | +1 (250) | +2 (500) | +3 (1000) | | Proposed device (mg/dl) | +4 (1000) | | | | | 15 | | | +3 (500) | | | | 14 | 1 | | | +2 (250) | | 2 | 15 | 1 | | | | +1 (100) | | 32 | 1 | | | | | ± (50) | | 4 | | | | | | - | 255 | | | | | | Total | | 255 | 38 | 16 | 15 | 16 | | % Agreement (exact match) | | 100 | 84 | 94 | 93 | 94 | | % Agreement (±1 color block) | | 100 | 100 | 100 | 100 | 100 | | | SG | Predicate device | | | | | | | --- | --- | --- | --- | --- | --- | --- | --- | | | | 1.005 | 1.010 | 1.015 | 1.020 | 1.025 | 1.030 | | Proposed device | 1.030 | | | | | 1 | 39 | | | 1.025 | | | | 8 | 53 | 9 | | | 1.020 | | | 20 | 78 | 13 | | | | 1.015 | | 5 | 34 | 9 | 2 | | | | 1.010 | 4 | 43 | | | | | | | 1.005 | 15 | 7 | | | | | | Total | | 19 | 55 | 54 | 95 | 69 | 48 | | % Agreement (exact match) | | 79 | 78 | 63 | 82 | 77 | 81 | | % Agreement (±1 color block) | | 100 | 100 | 100 | 100 | 97 | 100 | | | pH | Predicate device | | | | | | | | | | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | | | | 5.0 | 5.5 | 6.0 | 6.5 | 7.0 | 7.5 | 8.0 | 8.5 | 9.0 | | Proposed device | 9.0 | | | | | | | | | 4 | | | 8.5 | | | | | | | | 4 | | | | 8.0 | | | | | | | 5 | 1 | | | | 7.5 | | | | | | 12 | 1 | | | | | 7.0 | | | | 2 | 34 | 5 | | | | | | 6.5 | | | | 36 | 10 | | | | | | | 6.0 | | | 142 | 12 | | | | | | | | 5.5 | 3 | 17 | 24 | | | | | | | | | 5.0 | 14 | 7 | 7 | | | | | | | {23} | Total | 17 | 24 | 173 | 50 | 44 | 17 | 6 | 5 | 4 | | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | | % Agreement (exact match) | 82 | 71 | 82 | 72 | 72 | 71 | 83 | 80 | 100 | | % Agreement (±1 color block) | 100 | 100 | 96 | 100 | 100 | 100 | 100 | 100 | 100 | # 5. Summary of Data Uritest-50 with Uritest 10G VS. Clinitek 500 with Multistix 10SG | Analyte | % Agreement (within ±1 color block) | % Agreement (exact match) | Analyte | % Agreement (within ±1 color block) | % Agreement (exact match) | | --- | --- | --- | --- | --- | --- | | Leukocytes | 100 (340/340) | 94.4 (321/340) | Ketone | 100 (340/340) | 97.9 (333/340) | | Nitrite | 100 (340/340) | 99.7 (339/340) | Urobilinogen | 100 (340/340) | 98.8 (336/340) | | Bilirubin | 100 (340/340) | 98.2 (334/340) | Protein | 99.1 (337/340) | 95.3 (324/340) | | Glucose | 100 (340/340) | 96.2 (327/340) | Specific Gravity | 99.1 (337/340) | 80.0 (272/340) | | Blood | 99.4 (338/340) | 92.1 (313/340) | pH | 99.4 (338/340) | 78.5 (267/340) | Uritest-500B with Uritest 11G VS. Clinitek 500 with Multistix 10SG | Analyte | % Agreement (within ±1 color block) | % Agreement (exact match) | Analyte | % Agreement (within ±1 color block) | % Agreement (exact match) | | --- | --- | --- | --- | --- | --- | | Leukocytes | 100 (340/340) | 95.9 (326/340) | Ketone | 100 (340/340) | 98.5 (335/340) | | Nitrite | 100 (340/340) | 100 (340/340) | Urobilinogen | 100 (340/340) | 97.9 (333/340) | | Bilirubin | 100 (340/340) | 99.1 (337/340) | Protein | 99.1 (337/340) | 95.0 (323/340) | | Glucose | 100 (340/340) | 97.4 (331/340) | Specific Gravity | 99.4 (338/340) | 77.1 (262/340) | | Blood | 99.1 (337/340) | 94.1 (320/340) | pH | 97.9 (333/340) | 78.8 (268/340) | b. Matrix comparison: {24} Not applicable, this device is only used with urine. 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): 4. Clinical cut-off: Not applicable 5. Expected values/Reference range: Reference ranges were drawn from literature: Ketone: &lt; 5 mg/dL Nitrite: 0 mg/dL Urobilinogen: 0.2-1.0 EU/dL Bilirubin: 0 mg/dL Protein: &lt; 15 mg/dL Glucose: &lt; 50 mg/dL Specific Gravity: 1.010-1.025 Blood: &lt; 10 ery/micL Ascorbic Acid: &lt; 10 mg/dL **BIBLIOGRAPHY** 1. "European Urinalysis Guidelines", The Scandinavian Journal of Clinical &amp; Laboratory Investigation, Scand J Clin Lab Invest-Vol. 60-Supplement 231.2000. 2. "The Clinical Analysis of Urine Recent Period", The Science and Technology Publishing House, Yu Long Cong, Jun Long Ma, Editors; 1998; pp. 37-81, 96-97. 3. "Compendium – Urinalysis with Test Strips" Roche Diagnostic, Combur® Reagent Strips. N. Instrument Name: Uritest-50 and Uritest 500B O. System Descriptions: 1. Modes of Operation: The Uritest 50 and Uritest-500B are automated urine analyzers using reflectance 25 {25} spectroscopy for the semi-quantitative determination of pH, Specific Gravity, Protein, Glucose, Ketones, Urobilinogen, Bilirubin, Leukocyte esterase, Blood, Nitrite and Ascorbic Acid in urine samples. English is the default language. 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: Numerical specimen identification information can be entered manually via a keypad on the analyzers, or it is available for use with a bar code scanner using the PS/2 port on the back of the instruments. 4. Specimen Sampling and Handling: Uritest-50 analyzes one strip at a time. The user must wait for the completion of the strip before loading the next one. Uritest 500B can analyze multiple strips. The user wets the test strip and places it on a sample tray. The analyzer pulls the strip inside to begin timing and analysis. The instrument prompts the user to wet another strip and put it on the tray thereby allowing multiple strips to be processed for analysis at one time. 5. Calibration: Calibration is factory set, however a white calibration strip is used to check the remittance outputs of the LEDs in the read head. Labeling recommends that the user perform the calibration verification with the white strip after maintenance, with a new lot of strips, with a new bottle of strips, change of operator, or when there is a question with results. 6. Quality Control: QC is analyzed like the patient samples. The QC data is not stored separately from patient data, however both analyzers can be connected to a computer via a RS 232 port. Labeling recommends two levels of quality control need to be assayed according to state, federal and local guidelines and 1) after using the check strip, 2) after maintenance or service 3) when starting a new lot number of test strips, 4) when starting a new bottle of test strips 5) changing operator, 6) when there are questionable results, 7) every 30 days to check the storage conditions of the strips. P. Other Supportive Instrument Performance Characteristics Data Not Covered In The "Performance Characteristics" Section above: 26 {26} 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. 27