URITEK TC-201 URINE CHEMISTRY TEST SYSTEM
Device Facts
| Record ID | K160372 |
|---|---|
| Device Name | URITEK TC-201 URINE CHEMISTRY TEST SYSTEM |
| Applicant | Teco Diagnostics, Inc. |
| Product Code | JIL · Clinical Chemistry |
| Decision Date | Jul 22, 2016 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 862.1340 |
| Device Class | Class 2 |
Intended Use
The Uritek TC-201 Urine Chemistry Test System consists of the Uritek TC-201 Urine Chemistry Analyzer and the Teco Diagnostics Urine Reagent (URS-10) Strips. The Uritek TC-201 urine analyzer is an automated, bench top instrument which is intended for point-of-care, in vitro diagnostic use only and is intended to be used together with the Teco Diagnostics Urine Reagent (URS-10) Strips as a system for semi-quantitative detection of Glucose, Bilirubin, Ketone, Specific Gravity, Blood, pH, Protein, Urobilinogen, Nitrite and Leukocytes in urine. These measurements are used to aid in the diagnosis of metabolic disorders, kidney function anomalies, urinary tract infections and liver function.
Device Story
Uritek TC-201 is an automated, benchtop urinalysis system for point-of-care use. It processes Teco Diagnostics URS-10 reagent strips; strips contain ten reagent pads saturated with chemicals. The analyzer irradiates test pads with light; a photodiode detects reflectance at specific wavelengths. The device calculates results based on reflection rates; results are displayed on a touchscreen and printed via an internal thermal printer. Operators (clinicians/technicians) use the system to aid in diagnosing metabolic, kidney, urinary, and liver conditions. The device features self-calibration using a white reflective check area on the strip bed. It provides semi-quantitative results in one minute, facilitating immediate clinical decision-making.
Clinical Evidence
No clinical trials were performed. Evidence consists of analytical performance studies including precision (within-run, run-to-run, and point-of-care), linearity, detection limits, and interference testing. A method comparison study was conducted at three point-of-care sites comparing the Uritek TC-201 system to the Siemens Clinitek Status+ analyzer using 509 clinical urine samples (including 44 contrived samples). Results showed high agreement, with overall exact match rates for most analytes exceeding 90% and 100% agreement within ±1 color block.
Technological Characteristics
Reflectance photometer; uses Teco Diagnostics URS-10 reagent strips (bibulous pads on plastic). Self-calibration via white reflective check area. Dimensions: 7.25" x 10.5" x 6.5". Power: 100-240 VAC. Connectivity: serial computer interface. Complies with IEC 61010-1, IEC 61010-2-101 (electrical safety), and IEC 61326-1/2 (EMC).
Indications for Use
Indicated for point-of-care, in vitro diagnostic use to aid in the diagnosis of metabolic disorders, kidney function anomalies, urinary tract infections, and liver function by semi-quantitatively detecting glucose, bilirubin, ketone, specific gravity, blood, pH, protein, urobilinogen, nitrite, and leukocytes in human urine.
Regulatory Classification
Identification
A urinary glucose (nonquantitative) test system is a device intended to measure glucosuria (glucose in urine). Urinary glucose (nonquantitative) measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, hypoglycemia, and hyperglycemia.
Predicate Devices
- Siemens Clinitek Status Plus Analyzer (k091216)
Related Devices
- K101673 — URITEK TC-101 URINE ANALYZER, URINE REAGENT STRIPS 10, MODELS TC-101, URS-10 · Teco Diagnostics · Feb 4, 2011
- K141289 — TC-THUNDERBOLT AUTOMATED URINE ANALYZER SYSTEM AND TC-THUNDERBOLT URS-10 STRIPS · Teco Diagnostics · Jul 24, 2015
- K152835 — URITEK TC-201 URINE CHEMISTRY TEST SYSTEM · Teco Diagnostics, Inc. · Mar 7, 2016
Submission Summary (Full Text)
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# 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY ONLY TEMPLATE
A. 510(k) Number:
k160372
B. Purpose for Submission:
New urinalysis test system composed of a previously cleared urinalysis analyzer (k152835) and previously cleared urinalysis strips (k970250)
C. Measurand:
Urinary glucose, blood, leukocytes, pH, nitrite, protein, ketones, urobilinogen, bilirubin, and specific gravity
D. Type of Test:
Qualitative and semi-quantitative urinalysis
E. Applicant:
Teco Diagnostics
F. Proprietary and Established Names:
Uritek TC-201 Urine Chemistry Test System
Uritek TC-201 Urine Analyzer
Uritek Reagent Strips (URS-10)
G. Regulatory Information:
| Regulation | Product Code | Test Name | Device Class | Panel |
| --- | --- | --- | --- | --- |
| 21 CFR 862.1340 | JIL | Urinary Glucose (nonquantitative) Test System | II | Chemistry (75) |
| 21 CFR 864.6550 | JIO | Occult Blood Test | II | Hematology (81) |
| 21 CFR 862.2900 | KQO | Automated Urinalysis System | I | Chemistry (75) |
| 21 CFR 864.7675 | LJX | Leukocyte Peroxidase Test | I | Hematology (81) |
| 21 CFR 862.2800 | JRE | Refractometer for clinical use | I | Chemistry (75) |
| 21 CFR 862.1550 | CEN | Urinary pH (nonquantitative) | I | Chemistry (75) |
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| Regulation | Product Code | Test Name | Device Class | Panel |
| --- | --- | --- | --- | --- |
| | | Test System | | |
| 21 CFR 862.1510 | JMT | Nitrite (nonquantitative) Test System | I | Chemistry (75) |
| 21 CFR 862.1645 | JIR | Urinary Protein or Albumin (nonquantitative) Test System | I | Chemistry (75) |
| 21 CFR 862.1435 | JIN | Ketones (nonquantitative) Test System | I | Chemistry (75) |
| 21 CFR 862.1785 | CDM | Urinary Urobilinogen (nonquantitative) Test System | I | Chemistry (75) |
| 21 CFR 862.1115 | JJB | Urinary Bilirubin and its conjugates (nonquantitative) Test System | I | Chemistry (75) |
H. Intended Use:
1. Intended use(s):
See Indication(s) for use below.
2. Indication(s) for use:
The Uritek TC-201 Urine Chemistry Test System consists of the Uritek TC-201 Urine Chemistry Analyzer and the Teco Diagnostics Urine Reagent (URS-10) Strips. The Uritek TC-201 Urine Analyzer is an automated, bench top instrument which is intended for point-of-care, in vitro diagnostic use only. The instrument is intended to be used together with the Teco Diagnostics Urine Reagent (URS-10) Strips as a system for semi-quantitative detection of Glucose, Bilirubin, Ketone, Specific Gravity, Blood, pH, Protein, Urobilinogen, Nitrite and Leukocytes in urine. These measurements are used to aid in the diagnosis of metabolic disorders, kidney function anomalies, urinary tract infections and liver function.
3. Special conditions for use statement(s):
For prescription use
4. Special instrument requirements:
Uritek TC-201 Urine Analyzer
I. Device Description:
The Uritek TC-201 Urine Analyzer (TC-201) is a portable instrument for use with Urine Reagent (URS-10) Strips for testing at point-of-care sites. The analyzer can determine the intensity of different colors on the reagent strip test area using the principle of light reflection
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by photodiode. Results are calculated by a reflection rate which is a percentage of the total reflectance of the testing wavelength and are printed automatically.
The Uritek TC-201 Urine Analyzer reports semi-quantitative results for Glucose, Bilirubin, Ketone, Specific Gravity, Blood, pH, Protein, Urobilinogen, Nitrite, and Leukocytes in urine. The analyzer features a display, internal printer, a serial computer interface and an electrical outlet. Communication between the operator and the analyzer is made through the display using the user interface touch screen on the front surface of the instrument. Reagent strip results are automatically displayed on the screen in one minute. A printed hardcopy can also be created either from the results screen or recalled from memory.
The Teco Diagnostic Urine Reagent Strips (URS-10, previously cleared in k970250) are firm plastic strips to which ten different reagent pads are affixed. The reagent pad areas are bibulous material saturated with chemically active substances, then dried and affixed to the plastic strip with double-sided adhesive. The Urine Reagent (URS-10) Strips provide tests for the semi-quantitative and qualitative determination of Glucose, Bilirubin, Ketone, Specific Gravity, Blood, pH, Protein, Urobilinogen, Nitrite, and Leukocytes in urine.
# J. Substantial Equivalence Information:
1. Predicate device name(s):
Siemens Clinitek Status Plus Analyzer
2. Predicate 510(k) number(s):
k091216
3. Comparison with predicate:
| Similarities | | |
| --- | --- | --- |
| Item | Candidate Device Uritek TC-201 Test System | Predicate Device Clinitek Status Plus k091216 |
| Intended Use | For the semi-quantitative detection of glucose, bilirubin, ketone, specific gravity, blood, pH, protein, urobilinogen, nitrite, and leukocytes in urine. | Same |
| Indications for Use | Aid in the diagnosis of metabolic disorders, kidney function anomalies, urinary tract infections, and liver function. | Same |
| Analyzer Basic Operating Principle | Reflectance Photometer | Same |
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| Similarities | | |
| --- | --- | --- |
| Item | Candidate Device Uritek TC-201 Test System | Predicate Device Clinitek Status Plus k091216 |
| Specimen Type | Urine | Same |
| Analyzer calibration method | Self-calibration with a white reflective check area located at the back of the test strip bed | Same |
| Analyzer operating conditions | 64-86°F (18-30°C); 18%-80% R.H. | Same |
| Test Strip physical description | Plastic strips affixed with reagent pads | Same |
| Test strip storage temperature | 59-86°F (15-30°C) | Same |
| Differences | | |
| --- | --- | --- |
| Item | Candidate Device Uritek TC-201 Test System | Predicate Device Clinitek Status Plus k091216 |
| Analyzer Power | Input 100-240 VAC ± 20% and 45-65Hz, output + 9V | Input 100-240 VAC ± 20% and 45-65Hz, output + 9V or 6 AA non-rechargeable alkaline batteries |
| Analyzer Memory | Stores up to 2000 test results | Stores up to 950 test results |
| Display Language | English, Spanish, Chinese | English, Spanish |
| Screen Display | Color | Mono-tone |
| Analyzer Dimensions | Width 7.25 inches Depth 10.5 inches Height 6.5 inches | Width 6.7 inches Depth 10.7 inches Height 6.2 inches |
| Analyzer Weight | 4.14 lbs (1.88 kg) | 3.65 lbs (1.66 kg) |
| Test Strips | Teco Diagnostic Urine Reagent (URS-10) strips | Clinitek Multistix 10 SG |
# K. Standard/Guidance Document Referenced (if applicable):
ISO 14971 "Medical Devices – Applications to risk management to medical devices"
EP07-A2 "Interference Testing in Clinical Chemistry; Approved Guideline – Second Edition"
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L. Test Principle:
| Analyte | Test Principle |
| --- | --- |
| Glucose | Based on a double sequential enzyme reaction. One enzyme, glucose oxidase, catalyzes the reaction in which glucose is oxidized to produce gluconic acid and hydrogen peroxide. A second enzyme, peroxidase, catalyzes the reaction of hydrogen peroxide with potassium iodide chromogen in which the chromogen is oxidized to different colors ranging from blue-green to greenish-brown through brown and dark brown. |
| Bilirubin | Based on the coupling of bilirubin with a diazotized dichloroaniline in a strongly acid medium. Varying bilirubin levels will produce light tan to reddish brown color proportional to its concentration in urine. |
| Ketone | Based on the reaction of acetoacetic acid with sodium nitroprusside in a strongly basic medium. The colors range from beige or buff-pink color for a "Negative" reading to pink and pink-purple for a "Positive" reading. |
| Specific Gravity | Based on the apparent pKa change of certain pretreated polyelectrolytes in relation to the ionic concentration. In the presence of an indicator, the colors range from dark blue or blue-green in urine of low ionic concentration to green and yellow-green in urine of higher ionic concentration. |
| Blood | Based on the pseudoperoxidase action of hemoglobin and erythrocytes which catalyzes the reaction of 3,3',5,5'-tetramethyl-benzidine and buffered organic peroxide. The resulting colors range from orange to yellow-green and dark green. Very high blood concentration may cause the color development to continue to dark blue. |
| pH | Based on the well-known double pH indicator method, where bromothymol blue and methyl red give distinguishable colors over the pH range of 5-9. The colors range from red-orange to yellow and yellow-green to blue-green. |
| Protein | Based on the protein error-of-indicator principle. At a constant pH, the development of any green color is due to the presence of protein. Colors range from yellow for a "Negative" reaction to yellow-green and green to blue-green for a "Positive" reaction. |
| Urobilinogen | Based on a modified Ehrlich reaction in which p-diethylaminobenzaldehyde reacts with urobilinogen in a strongly acid medium. Colors range from light pink to bright magenta. |
| Nitrite | This test depends on the conversion of nitrate to nitrite by the action of Gram-negative bacteria in the urine. The nitrite reacts |
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| Analyte | Test Principle |
| --- | --- |
| | with p-arsanilic acid to from a diazonium compound in an acid medium. The diazonium compound in turn couples with 1, 2, 3, 4- tetrahydrobenzo (h) quinolin to produce a pink color. |
| Leukocyte | Based on the action of esterase present in leukocytes, which catalyzes the hydrolysis of an indoxyl ester derivative. The indoxyl ester liberated reacts with a diazonium salt to produce a beige-pink to purple color. |
## M. Performance Characteristics (if/when applicable):
### 1. Analytical performance:
#### a. Precision/Reproducibility:
Within Run Precision of the Uritek TC-201 Urine Chemistry Test System was evaluated by three operators testing 20 replicates of commercially available urine control solutions at (negative, low positive, and high positive) on three analyzers with three strip lots.
The results are summarized below:
**Control Level I (High analyte concentration)**
| Analyte | Control Level I | Exact Match Agreement (%) | +/- 1 Color Block Agreement (%) |
| --- | --- | --- | --- |
| Glucose | 1000 mg/dL | 177/180 (98.33%) | 180/180 (100%) |
| Bilirubin | Large | 177/180 (98.33%) | 180/180 (100%) |
| Ketone | 80 mg/dL | 179/180 (99.44%) | 180/180 (100%) |
| Specific Gravity | 1.015 | 176/180 (97.78%) | 180/180 (100%) |
| Blood | Large | 180/180 (100%) | 180/180 (100%) |
| Nitrite | Positive | 180/180 (100%) | 180/180 (100%) |
| Protein | 300 mg/dL | 180/180 (100%) | 180/180 (100%) |
| Urobilinogen | 8.0 EU/dL | 180/180 (100%) | 180/180 (100%) |
| Leukocyte | Large | 180/180 (100%) | 180/180 (100%) |
| pH | 8.0 | 173/180 (96.11%) | 180/180 (100%) |
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Control Level II (Low analyte concentration)
| Analyte | Control Level II | Exact Match Agreement (%) | +/- 1 Color Block Agreement (%) |
| --- | --- | --- | --- |
| Glucose | 250 mg/dL | 179/180 (99.44%) | 180/180 (100%) |
| Bilirubin | Small | 180/180 (100%) | 180/180 (100%) |
| Ketone | 40 mg/dL | 180/180 (100%) | 180/180 (100%) |
| Specific Gravity | 1.010 | 178/180 (98.89%) | 180/180 (100%) |
| Blood | Moderate | 180/180 (100%) | 180/180 (100%) |
| Nitrite | Positive | 180/180 (100%) | 180/180 (100%) |
| Protein | Trace | 179/180 (99.44%) | 180/180 (100%) |
| Urobilinogen | 0.2 EU/dL | 180/180 (100%) | 180/180 (100%) |
| Leukocyte | Moderate | 178/180 (98.89%) | 180/180 (100%) |
| pH | 8.0 | 179/180 (99.44%) | 180/180 (100%) |
Control Level III (Negative)
| Analyte | Control Level III | Exact Match Agreement (%) | +/- 1 Color Block Agreement (%) |
| --- | --- | --- | --- |
| Glucose | Negative | 180/180 (100%) | 180/180 (100%) |
| Bilirubin | Negative | 180/180 (100%) | 180/180 (100%) |
| Ketone | Negative | 180/180 (100%) | 180/180 (100%) |
| Specific Gravity | 1.010 | 179/180 (99.44%) | 180/180 (100%) |
| Blood | Negative | 180/180 (100%) | 180/180 (100%) |
| Nitrite | Negative | 180/180 (100%) | 180/180 (100%) |
| Protein | Negative | 180/180 (100%) | 180/180 (100%) |
| Urobilinogen | 0.2 EU/dL | 180/180 (100%) | 180/180 (100%) |
| Leukocyte | Negative | 180/180 (100%) | 180/180 (100%) |
| pH | 6.0 | 178/180 (98.89%) | 180/180 (100%) |
The Run to Run precision was performed by testing three replicates of three levels of control solution (negative, low positive, and high positive) by two operators on two analyzers with three lots of URS-10 strips over two2 non-consecutive runs per day for 10 days. Run 1 and Run 2 were separated by at least 1 hour.
The results are summarized below:
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Control Level I (High analyte concentration)
| Analyte | Control Level I | Exact Match Agreement (%) | +/- 1 Color Block Agreement (%) |
| --- | --- | --- | --- |
| Glucose | 1000 mg/dL | 120/120 (100%) | 120/120 (100%) |
| Bilirubin | Large | 119/120 (99.17%) | 120/120 (100%) |
| Ketone | 80 mg/dL | 120/120 (100%) | 120/120 (100%) |
| Specific Gravity | 1.015 | 118/120 (98.33%) | 120/120 (100%) |
| Blood | Large | 120/120 (100%) | 120/120 (100%) |
| Nitrite | Positive | 120/120 (100%) | 120/120 (100%) |
| Protein | 300 mg/dL | 120/120 (100%) | 120/120 (100%) |
| Urobilinogen | 8.0 EU/dL | 120/120 (100%) | 120/120 (100%) |
| Leukocyte | Large | 120/120 (100%) | 120/120 (100%) |
| pH | 8.0 | 117/120 (97.50%) | 120/120 (100%) |
Control Level II (Low analyte concentration)
| Analyte | Control Level II | Exact Match Agreement (%) | +/- 1 Color Block Agreement (%) |
| --- | --- | --- | --- |
| Glucose | 250 mg/dL | 120/120 (100%) | 120/120 (100%) |
| Bilirubin | Small | 120/120 (100%) | 120/120 (100%) |
| Ketone | 40 mg/dL | 120/120 (100%) | 120/120 (100%) |
| Specific Gravity | 1.010 | 117/120 (97.50%) | 120/120 (100%) |
| Blood | Moderate | 120/120 (100%) | 120/120 (100%) |
| Nitrite | Positive | 120/120 (100%) | 120/120 (100%) |
| Protein | Trace | 119/120 (99.17%) | 120/120 (100%) |
| Urobilinogen | 0.2 EU/dL | 120/120 (100%) | 120/120 (100%) |
| Leukocyte | Moderate | 120/120 (100%) | 120/120 (100%) |
| pH | 8.0 | 119/120 (99.17%) | 120/120 (100%) |
Control Level III (Negative)
| Analyte | Control Level III | Exact Match Agreement (%) | +/- 1 Color Block Agreement (%) |
| --- | --- | --- | --- |
| Glucose | Negative | 120/120 (100%) | 120/120 (100%) |
| Bilirubin | Negative | 120/120 (100%) | 120/120 (100%) |
| Ketone | Negative | 120/120 (100%) | 120/120 (100%) |
| Specific Gravity | 1.010 | 120/120 (100%) | 120/120 (100%) |
| Blood | Negative | 120/120 (100%) | 120/120 (100%) |
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| Nitrite | Negative | 120/120 (100%) | 120/120 (100%) |
| --- | --- | --- | --- |
| Protein | Negative | 120/120 (100%) | 120/120 (100%) |
| Urobilinogen | 0.2 EU/dL | 120/120 (100%) | 120/120 (100%) |
| Leukocyte | Negative | 120/120 (100%) | 120/120 (100%) |
| pH | 6.0 | 120/120 (100%) | 120/120 (100%) |
## Point-of-care Precision
Precision of the Uritek TC-201 Urine Analyzer Test System was evaluated at three point-of-care sites using three levels of control solution (negative, low positive, and high positive). At each site, three operators used three test strip lots and one analyzer to test each sample in duplicate for two runs per day for 10 days.
Results for all sites combined are summarized below:
| | Control Level I
(High Positive) | | Control Level II
(Low Positive) | | Control Level III
(Negative) | |
| --- | --- | --- | --- | --- | --- | --- |
| Analyte | Exact Match | ±1 Color Block Agreement | Exact Match | ±1 Color Block Agreement | Exact Match | ±1 Color Block Agreement |
| Glucose | 100% (120/120) | 100% (120/120) | 100% (120/120) | 100% (120/120) | 100% (120/120) | 100% (120/120) |
| Bilirubin | 100% (120/120) | 100% (120/120) | 99.17% (119/120) | 100% (120/120) | 100% (120/120) | 100% (120/120) |
| Ketone | 100% (120/120) | 100% (120/120) | 100% (120/120) | 100% (120/120) | 100% (120/120) | 100% (120/120) |
| Specific Gravity | 99.17% (119/120) | 100% (120/120) | 100% (120/120) | 100% (120/120) | 100% (120/120) | 100% (120/120) |
| Blood | 100% (120/120) | 100% (120/120) | 99.17% (119/120) | 100% (120/120) | 100% (120/120) | 100% (120/120) |
| Nitrite | 100% (120/120) | 100% (120/120) | 100% (120/120) | 100% (120/120) | 100% (120/120) | 100% (120/120) |
| Protein | 100% (120/120) | 100% (120/120) | 100% (120/120) | 100% (120/120) | 100% (120/120) | 100% (120/120) |
| Urobilinogen | 99.17% (119/120) | 100% (120/120) | 100% (120/120) | 100% (120/120) | 100% (120/120) | 100% (120/120) |
| Leukocyte | 100% (120/120) | 100% (120/120) | 99.17% (119/120) | 100% (120/120) | 100% (120/120) | 100% (120/120) |
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b. Linearity/assay reportable range:
The study to evaluate the reportable range (percent recovery) for each semi-quantitative level of the Uritek TC-201 Urine Chemistry Test System was performed by measuring a negative urine and a negative urine pool spiked with known increasing and decreasing concentrations of analytes relative to each semi-quantitative level. Samples were measured in replicates of eight by three operators on three reagents strip lots for a total of 24 measurements for every sample. A pH meter was used to confirm the pH results. The specific gravity was confirmed by a clinical, handheld refractometer.
The percent recovery for each analyte at each concentration block is shown in the table below:
| Analyte | Color Block Output Units (Reportable Range) | | Concentration Tested | Percent Exact Match |
| --- | --- | --- | --- | --- |
| | Arbitrary | Conventional | | |
| Glucose | - | 0 mg/dL | 0 mg/dL | 100% |
| | ± | 100 mg/dL | 100 mg/dL | 100% |
| | 1+ | 250 mg/dL | 250 mg/dL | 100% |
| | 2+ | 500 mg/dL | 500 mg/dL | 100% |
| | 3+ | 1000 mg/dL | 1000 mg/dL | 100% |
| Bilirubin | - | Negative | 0 mg/dL | 100% |
| | 1+ | Small | 1.0 mg/dL | 100% |
| | 2+ | Moderate | 2.0 mg/dL | 100% |
| | 3+ | Large | 4.0 mg/dL | 100% |
| Ketone | - | Negative | 0 mg/dL | 100% |
| | ± | Trace | 5.0 mg/dL | 100% |
| | 1+ | 15 mg/dL | 15 mg/dL | 100% |
| | 2+ | 40 mg/dL | 40 mg/dL | 100% |
| | 3+ | 80 mg/dL | 80 mg/dL | 100% |
| Blood | - | Negative | 0 Ery/μL | 100% |
| | ± | Trace | 10 Ery/μL | 100% |
| | 1+ | Small | 25 Ery/μL | 100% |
| | 2+ | Moderate | 80 Ery/μL | 100% |
| | 3+ | Large | 200 Ery/μL | 100% |
| Protein | - | Negative | 0 mg/dL | 100% |
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| Analyte | Color Block Output Units (Reportable Range) | | Concentration Tested | Percent Exact Match |
| --- | --- | --- | --- | --- |
| | Arbitrary | Conventional | | |
| | ± | Trace | 15 mg/dL | 90% |
| | 1+ | 30 mg/dL | 30 mg/dL | 100% |
| | 2+ | 100 mg/dL | 100 mg/dL | 95% |
| | 3+ | 300 mg/dL | 300 mg/dL | 95% |
| Nitrite | - | Negative | 0 mg/dL | 100% |
| | + | Positive | 0.1 mg/dL | 100% |
| Leukocyte | - | Negative | 0 ca cells/μL | 95% |
| | ± | Trace | 15 ca cells/μL | 95% |
| | 1+ | Small | 70 ca cells/μL | 95% |
| | 2+ | Moderate | 125 ca cells/μL | 100% |
| | 3+ | Large | 500 ca cells/μL | 100% |
| Urobilinogen | 0.2 | 0.2 EU/dL | 0.2 EU/dL | 100% |
| | 1.0 | 1.0 EU/dL | 1.0 EU/dL | 100% |
| | 2.0 | 2.0 EU/dL | 2.0 EU/dL | 90% |
| | 4.0 | 4.0 EU/dL | 4.0 EU/dL | 100% |
| | 8.0 | 8.0 EU/dL | 8.0 EU/dL | 100% |
| pH | 5.0 | 5.0 | 5.0 | 95% |
| | 6.0 | 6.0 | 6.0 | 95% |
| | 6.5 | 6.5 | 6.5 | 95% |
| | 7.0 | 7.0 | 7.0 | 95% |
| | 7.5 | 7.5 | 7.5 | 95% |
| | 8.0 | 8.0 | 8.0 | 100% |
| | 8.5 | 8.5 | 8.5 | 100% |
| SG | 1.005 | 1.005 | 1.005 | 100% |
| | 1.010 | 1.010 | 1.010 | 100% |
| | 1.015 | 1.015 | 1.015 | 100% |
| | 1.020 | 1.020 | 1.020 | 100% |
| | 1.025 | 1.025 | 1.025 | 100% |
| | 1.030 | 1.030 | 1.030 | 100% |
c. Traceability, Stability, Expected values (controls, calibrators, or methods):
The Uritek TC-201 Urine Analyzer performs a 10 second system calibration using a white reflective check area at the back of the test strip bed prior to analyzing a test strip.
The urine test strip stability was established in k905396 to support storage between $15 - 30^{\circ}\mathrm{C}$ (59-86°F) at 20-30% humidity out of direct sunlight for 2 years, and to support an open-vial stability of 90 days at room temperature (15-30°C).
d. Detection limit:
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A study was performed to validate the cut-off concentration for each semiquantitative level measured by the Uritek TC-201 Urine Chemistry Test System. Samples were prepared by spiking a negative urine pool with a minimum of four levels across the measuring range for each analyte concentration. The samples were analyzed in replicates of eight by three operators on three reagent strip lots, for a total of 24 data points for each level. The low cut-off concentration for each color block was defined as the lowest concentration at which $>55\%$ of the test results are positive.
The cut-off values and percentage sensitivity for each color block for individual analyte is summarized and demonstrated in the table below:
| Analyte | Color Block | Cut-off | % Positive Results |
| --- | --- | --- | --- |
| Glucose | 100 mg/dL | 75 mg/dL | 67% |
| | 250 mg/dL | 212.5 mg/dL | 83% |
| | 500 mg/dL | 437.5 mg/dL | 83% |
| | 1000 mg/dL | 875 mg/dL | 75% |
| Bilirubin | Small | 0.5 mg/dL | 59% |
| | Moderate | 1.75 mg/dL | 87.5% |
| | Large | 3.0 mg/dL | 62.5% |
| Ketone | Trace | 3.75 mg/dL | 71% |
| | 15 mg/dL | 10 mg/dL | 71% |
| | 40 mg/dL | 27.5 mg/dL | 91% |
| | 80 mg/dL | 60 mg/dL | 75% |
| Blood | Trace | 7.5 Ery/μL | 71% |
| | Small | 21.25 Ery/μL | 75% |
| | Moderate | 52.5 Ery/μL | 67% |
| | Large | 170 Ery/μL | 71% |
| Protein | Trace | 11.25 mg/dL | 91% |
| | 30 mg/dL | 26.25 mg/dL | 75% |
| | 100 mg/dL | 65 mg/dL | 87% |
| | 300 mg/dL | 200 mg/dL | 87% |
| Nitrite | Positive | 0.075 mg/dL | 58% |
| Leukocyte | Trace | 11.25 ca cells/μL | 58% |
| | Small | 56.25 ca cells/μL | 67% |
| | Moderate | 111.25 ca cells/μL | 58% |
| | Large | 312.5 ca cells/μL | 67% |
| Urobilinogen | 0.2 mg/dL | 0.2 mg/dL | 100% |
| | 1.0 mg/dL | 0.8 mg/dL | 71% |
| | 2.0 mg/dL | 2.0 mg/dL | 90% |
| | 4.0 mg/dL | 3.5 mg/dL | 55% |
| | 8.0 mg/dL | 7.0 mg/dL | 85% |
| pH | 5.0 | 5.0 | 96% |
| | 6.0 | 6.0 | 100% |
| | 6.5 | 6.5 | 96% |
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| Analyte | Color Block | Cut-off | % Positive Results |
| --- | --- | --- | --- |
| | 7.0 | 7.0 | 96% |
| | 7.5 | 7.5 | 96% |
| | 8.0 | 8.0 | 96% |
| | 8.5 | 8.5 | 96% |
| SG | 1.005 | 1.005 | 92% |
| | 1.010 | 1.010 | 92% |
| | 1.015 | 1.015 | 92% |
| | 1.020 | 1.020 | 92% |
| | 1.025 | 1.025 | 92% |
| | 1.030 | 1.030 | 92% |
# e. Analytical specificity:
Potential endogenous interferents and drugs commonly found in urine were evaluated to assess the interfering effect of various substances on the performance of the Uritek TC-201 Urine Chemistry Test System. Testing was performed using three urine pools with negative, low positive and positive concentrations for all analytes. At least two levels of the listed interferents were added. Each urine sample was tested in triplicate. The individual results of the samples spiked with the interfering substance at the stated concentration were compared against the control sample with no interfering substance. Interference was defined as a change in output of $\pm 1$ color blocks between spiked and unspiked control sample.
The concentrations of the potential interfering substances that did not have any influence on the test results are listed below:
| Potential Interfering Substance | Highest Concentration at which no interference was observed |
| --- | --- |
| Ascorbic Acid | 30 mg/dL |
| Ammonium Chloride | 200 mg/dL |
| Albumin | ≤125 mg/dL |
| Bilirubin | 8 mg/dL |
| Creatine | 10 mg/dL |
| Lithium Acetoacetate | ≤60 mg/dL |
| Calcium Chloride | 275 mg/dL |
| Citric Acid | 75 mg/dL |
| Creatinine | 400 mg/dL |
| D (+) Glucose | 2000 mg/dL |
| Glycine | 450 mg/dL |
| Hemoglobin | 10 mg/dL |
| Potassium Chloride | 1500 mg/dL |
| Sodium Chloride | 6000 mg/dL |
| Oxalic Acid | 70 mg/dL |
| Sodium Acetate | 25 mg/dL |
| Sodium Bicarbonate | 750 mg/dL |
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The following table shows the substances which did interfere with one or more of the Teco Diagnostics URS-10 strip analytes. Results are expressed as the lowest concentration of interfering substance that exhibited interference and the resulting change in output of color block.
| Analyte | Concentration of Substance at which Interference was observed | Change in Color block Output |
| --- | --- | --- |
| Glucose | Blood (≥ 5%), Hypochlorite (≥ 0.6%), Pyridium (≥ 50 mg/dL) | +1, |
| | Ascorbic Acid (≥ 75 mg/dL), Amoxicillin (≥ 100 mg/dL), Acetylcysteine (≥ 135 mg/dL) | -1 |
| Protein | Hemoglobin (≥ 20 mg/dL), Blood (≥ 1%), Sodium Bicarbonate (1500 mg/dL), Chloroquine (≥ 20 mg/dL), Pyridium (≥ 50 mg/dL), pH (> 8.5) | +1, +2 to +3, +1 to +2, +1 |
| | Amoxicillin (≥ 100 mg/dL), Hypochlorite (≥ 0.6%), SG (> 1.030) | -1 |
| Bilirubin | Blood (≥ 5%), Pyridium (≥ 50 mg/dL) | +2 to +3 |
| | Formalin (≥ 185 mg/dL), Boric Acid (≥ 500 mg/dL), Acetylcysteine (≥ 67.5 mg/dL), Hypochlorite (≥ 0.6%) | -1 |
| Urobilinogen | Blood (≥ 1%) | +1 |
| | Hypochlorite (≥ 0.6%) | -2 |
| SG | Albumin (≥ 200 mg/dL), Blood (1%) | +1 |
| | Nitrofurantoin (≥ 120 mg/dL) | -1 to -2 |
| | Amoxicillin (100 mg/dL), Hypochlorite (0.6%) | |
| Protein | Hemoglobin (200 mg/dL), Blood (1%) | +1 |
| | Bilirubin (100 mg/dL), Hypochlorite (0.6%) | -1 |
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15
| pH | SG (> 1.030), Sodium Bicarbonate (≥ 750 mg/dL), Sodium Phosphate (≥ 250 mg/dL), Creatinine (≥ 400 mg/dL) | +1 to +2 |
| --- | --- | --- |
| | Ascorbic Acid (≥75 mg/dL), Calcium Chloride (≥ 275 mg/dL) Citric Acid (≥ 75 mg/dL), Sodium Chloride (≥ 6000 mg/dL), Oxalic Acid (≥ 70 mg/dL) | -1 to -2 |
| Blood | Albumin (200 mg/dL), Hypochlorite (≥ 0.6%) | +2 |
| | Acetylcysteine (≥ 67.5 mg/dL) | -1 |
| Nitrite | Blood (≥ 1%), Hypochlorite (≥ 0.6%), Pyridium (≥ 50 mg/dL) | +1 |
| Leukocytes | Blood (≥ 1%), Pyridium (≥ 50 mg/dL) | +1 to +2, |
| | Glucose (≥ 2000 mg/dL), Boric Acid (≥ 500 mg/dL), Chloroquine (≥ 20 mg/dL), Amoxicillin (≥ 100 mg/dL), Hypochlorite (≥ 0.6%) | -1, -1 to -2 |
| Ketone | Blood (≥ 5%), Acetylcysteine (≥ 67.5 mg/dL), Pyridium (≥ 50 mg/dL) | +1, +2 to +3 |
| | Hypochlorite (≥ 0.6%) | -1 to -2 |
In addition to the interference described in the table above, the labeling includes limitations that the following substances may interfere with one or more analytes on the Uritek TC-201 Urine Chemistry Test System:
- Quaternary ammonium complexes
- Chlorpromazine
- Rafampen
- Indican
- Lodine metabolites
- Drugs containing azo dyes
- Microbial peroxidase
- Cephalexin
- MESNA
- Phenylketones
- L-Dopa
## pH Interference Study
An additional study to evaluate the effect of sample pH on the test results for the ten analytes in human urine was performed. The study result shows that sample pH from 5.0 to 9.0 does not affect the test results for leukocytes, urobilinogen, ketone, pH, blood, nitrite, bilirubin and glucose. Samples with pH greater than 8.5 affected the protein test resulting in a false high result.
## Specific Gravity Interference Study
An additional study was performed to evaluate the effect of sample specific gravity on the test results for the ten analytes in human urine. The study result shows that sample specific gravity from 1.000 to 1.040 does not affect the test results for
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leukocytes, urobilinogen, ketone, blood, nitrite, bilirubin and glucose. Samples with specific gravity greater than 1.030 affected the pH and protein tests resulting in a false low result.
The labeling includes the effects from pH and specific gravity as limitations of the procedure.
## Sample carry-over study
The interference of samples running over from one pad to the adjacent pad on the performance of the Uritek TC-201 Urine Chemistry Test System was evaluated. Prior to testing, the strip was dipped into commercially available urine control solutions (negative, low positive, high positive) and was then held upward to allow the sample to flow from the leukocyte pad to the next aligned pads or held downward to allow the sample flow from the glucose pad to the next aligned pads. Each holding method was tested in 3 replicates. The results support the claims that test results are not affected by sample carry-over.
f. Assay cut-off:
Not applicable.
## 2. Comparison studies:
a. Method comparison with predicate device:
A method comparison study was performed at three point-of-care sites using a single replicate of 392 clinical urine samples between the Urine Reagent (URS-10) Strips on the TC-201 Urine Analyzer and the Siemens Multistix 10 SG Reagent Strips on the Siemens Clinitek Status+ Urine Analyzer. 11% of the total samples were contrived (44 samples). At each site, six operators performed the testing using one lot of URS-10 test strips and one analyzer.
Additional method comparison data was obtained from POC Site I and Site II for 117 clinical samples. The total number of patient urine specimens evaluated in the method comparison study is 509.
Testing results are summarized in the following tables.
| Glucose | | Siemens Clinitek Status + Urine Analyzer | | | | | |
| --- | --- | --- | --- | --- | --- | --- | --- |
| 3 Sites, N=509 | | 1000 | 500 | 250 | 100 | Neg | Overall |
| Uritek TC-201 Urine Test System | 1000 | 16 | 4 | 0 | 0 | 0 | 20 |
| | 500 | 4 | 37 | 0 | 0 | 0 | 41 |
| | 250 | 0 | 0 | 10 | 0 | 0 | 10 |
| | 100 | 0 | 0 | 0 | 25 | 0 | 25 |
| | Neg | 0 | 0 | 0 | 0 | 413 | 413 |
| | Total | 20 | 41 | 10 | 25 | 413 | 509 |
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| Bilirubin | | Siemens Clinitek Status + Urine Analyzer | | | | |
| --- | --- | --- | --- | --- | --- | --- |
| 3 Sites, N=509 | | 3+ | 2+ | 1+ | Neg | Overall |
| Uritek TC-201 Urine Test System | 3+ | 35 | 1 | 0 | 0 | 36 |
| | 2+ | 0 | 31 | 0 | 0 | 31 |
| | 1+ | 0 | 0 | 51 | 5 | 56 |
| | Neg | 0 | 0 | 0 | 386 | 386 |
| | Total | 35 | 32 | 51 | 391 | 509 |
| Agreement within same color block (Exact Match) | | 100.0% (35/35) | 96.88% (31/32) | 100.0% (51/51) | 98.72% (386/391) | 98.82% (503/509) |
| Agreement within ±1 color block | | 100.0% (35/35) | 100.0% (32/32) | 100.0% (51/51) | 100.0% (391/391) | 100.0% (509/509) |
| Ketone | | Siemens Clinitek Status + Urine Analyzer | | | | | |
| --- | --- | --- | --- | --- | --- | --- | --- |
| 3 Sites, N=509 | | 80 | 40 | 15 | Trace | Neg | Overall |
| Uritek TC-201 Urine Test System | 80 | 13 | 1 | 0 | 0 | 0 | 14 |
| | 40 | 0 | 18 | 1 | 0 | 0 | 19 |
| | 15 | 0 | 0 | 24 | 1 | 0 | 25 |
| | TRA | 0 | 0 | 0 | 44 | 4 | 48 |
| | Neg | 0 | 0 | 0 | 1 | 402 | 403 |
| | Total | 13 | 19 | 25 | 46 | 406 | 509 |
| Agreement within same color block (Exact Match) | | 100.0% (13/13) | 94.74% (18/19) | 96.0% (24/25) | 95.65% (44/46) | 99.01% (402/406) | 98.43% (501/509) |
| Agreement within ±1 color block | | 100.0% (13/13) | 100.0% (19/19) | 100.0% (25/25) | 100.0% (46/46) | 100.0% (406/406) | 100.0% (509/509) |
| Specific Gravity | | Siemens Clinitek Status + Urine Analyzer | | | | | | |
| --- | --- | --- | --- | --- | --- | --- | --- | --- |
| 3 Sites, N=509 | | ≥1.030 | 1.025 | 1.020 | 1.015 | 1.010 | ≤1.005 | Overall |
| Uritek TC-201 Urine Test System | >1.030 | 57 | 5 | 0 | 0 | 0 | 0 | 62 |
| | 1.025 | 6 | 55 | 5 | 0 | 0 | 0 | 66 |
| | 1.020 | 0 | 21 | 112 | 10 | 0 | 0 | 143 |
| | 1.015 | 0 | 0 | 16 | 135 | 6 | 0 | 157 |
| | 1.010 | 0 | 0 | 0 | 8 | 40 | 7 | 55 |
| | <1.005 | 0 | 0 | 0 | 0 | 4 | 22 | 26 |
| | Total | 63 | 81 | 133 | 153 | 50 | 29 | 509 |
| Agreement within same color block (Exact Match) | | 90.48% (57/63) | 67.90% (55/81) | 84.21% (112/133) | 88.24% (135/153) | 80.0% (40/50) | 75.86% (22/29) | 82.71% (421/509) |
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| Agreement within ±1 color block | 100.0% (63/63) | 100.0% (81/81) | 100.0% (133/133) | 100.0% (153/153) | 100.0% (50/50) | 100.0% (29/29) | 100.0% (509/509) |
| --- | --- | --- | --- | --- | --- | --- | --- |
| Blood | | Siemens Clinitek Status + Urine Analyzer | | | | | |
| --- | --- | --- | --- | --- | --- | --- | --- |
| 3 Sites, N=509 | | 3+ | 2+ | 1+ | Trace | Neg | Overall |
| Uritek TC-201 Urine Test System | 3+ | 32 | 3 | 0 | 0 | 0 | 35 |
| | 2+ | 0 | 55 | 0 | 0 | 0 | 55 |
| | 1+ | 0 | 0 | 21 | 0 | 0 | 21 |
| | Trace | 0 | 0 | 1 | 63 | 2 | 66 |
| | Neg | 0 | 0 | 0 | 4 | 328 | 332 |
| | Total | 32 | 58 | 22 | 67 | 330 | 509 |
| Agreement within same color block (Exact Match) | | 100.0% (32/32) | 94.83% (55/58) | 95.45% (21/22) | 94.03% (63/67) | 99.39% (328/330) | 98.04% (499/509) |
| Agreement within ±1 color block | | 100.0% (32/32) | 100.0% (58/58) | 100.0% (22/22) | 100.0% (67/67) | 100.0% (330/330) | 100.0% (509/509) |
| Protein | | Siemens Clinitek Status + Urine Analyzer | | | | | |
| --- | --- | --- | --- | --- | --- | --- | --- |
| 3 Sites, N=509 | | >300 | 100 | 30 | Trace | Neg | Overall |
| Uritek TC-201 Urine Test System | >300 | 26 | 0 | 0 | 0 | 0 | 26 |
| | 100 | 0 | 35 | 0 | 0 | 0 | 35 |
| | 30 | 0 | 3 | 34 | 0 | 0 | 37 |
| | Trace | 0 | 0 | 2 | 46 | 6 | 54 |
| | Neg | 0 | 0 | 0 | 3 | 354 | 357 |
| | Total | 26 | 38 | 36 | 49 | 360 | 509 |
| Agreement within same color block (Exact Match) | | 100.0% (26/26) | 92.11% (35/38) | 94.44% (34/36) | 93.88% (46/49) | 98.33% (354/360) | 97.25% (495/509) |
| Agreement within ±1 color block | | 100.0% (26/26) | 100.0% (38/38) | 100.0% (36/36) | 100.0% (49/49) | 100.0% (360/360) | 100.0% (509/509) |
| Urobilinogen | | Siemens Clinitek Status + Urine Analyzer | | | | | |
| --- | --- | --- | --- | --- | --- | --- | --- |
| 3 Sites, N=509 | | >8.0 | 4 | 2 | 1 | 0.2 | Overall |
| Uritek TC-201 Urine Test System | >8.0 | 31 | 0 | 0 | 0 | 0 | 31 |
| | 4.0 | 0 | 26 | 0 | 0 | 0 | 26 |
| | 2.0 | 0 | 0 | 22 | 0 | 0 | 22 |
| | 1.0 | 0 | 0 | 0 | 14 | 0 | 14 |
| | 0.2 | 0 | 0 | 0 | 2 | 414 | 416 |
| | Total | 31 | 26 | 22 | 16 | 414 | 509 |
| Agreement within same color block (Exact Match) | | 100.0% (31/31) | 100.0% (26/26) | 100.0% (22/22) | 87.5% (14/16) | 100.0% (414/414) | 99.61% (507/509) |
| Agreement within ±1 color block | | 100.0% (31/31) | 100.0% (26/26) | 100.0% (22/22) | 100.0% (16/16) | 100.0% (414/414) | 100.0% (509/509) |
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| pH | | Siemens Clinitek Status + Urine Analyzer | | | | | | | |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| 3 Sites, N=509 | | 8.5 | 8.0 | 7.5 | 7.0 | 6.5 | 6.0 | 5.0 | Overall |
| Uritek TC-201 Urine Test System | 8.5 | 36 | 0 | 0 | 0 | 0 | 0 | 0 | 36 |
| | 8.0 | 2 | 15 | 5 | 0 | 0 | 0 | 0 | 22 |
| | 7.5 | 1 | 1 | 34 | 1 | 0 | 0 | 0 | 37 |
| | 7.0 | 0 | 0 | 0 | 100 | 0 | 0 | 0 | 100 |
| | 6.5 | 0 | 0 | 0 | 8 | 65 | 1 | 0 | 74 |
| | 6.0 | 0 | 0 | 0 | 0 | 11 | 89 | 8 | 108 |
| | 5.0 | 0 | 0 | 0 | 0 | 1 | 9 | 122 | 132 |
| | Total | 39 | 16 | 39 | 109 | 77 | 99 | 130 | 509 |
| Agreement within same color block (Exact Match) | | 92.31% (36/39) | 93.75% (15/16) | 87.18% (34/39) | 91.74% (100/109) | 84.42% (65/77) | 89.90% (89/99) | 93.85% (122/130) | 90.57% (461/509) |
| Agreement within ±1 color block | | 97.44% (38/39) | 100.0% (16/16) | 100.0% (39/39) | 100.0% (109/109) | 98.70% (76/77) | 100.0% (99/99) | 100.0% (130/130) | 99.61% (507/509) |
| Nitrite | | Siemens Clinitek Status + Urine Analyzer | | |
| --- | --- | --- | --- | --- |
| 3 Sites, N=509 | | POS | NEG | Overall |
| Uritek TC-201 Urine Test System | POS | 80 | 2 | 82 |
| | NEG | 1 | 426 | 427 |
| | Total | 81 | 428 | 509 |
| Agreement within same color block (Exact Match) | | 98.77% (80/81) | 99.53% (426/428) | 99.41% (506/509) |
| Agreement within ±1 color block | | N/A | N/A | N/A |
| Leukocyte | | Siemens Clinitek Status + Urine Analyzer | | | | | |
| --- | --- | --- | --- | --- | --- | --- | --- |
| 3 Sites, N=509 | | 3+ | 2+ | 1+ | Trace | Neg | Overall |
| | 3+ | 39 | 0 | 0 | 0 | 0 | 39 |
| Uritek TC-201 Urine Test System | 2+ | 0 | 12 | 0 | 0 | 0 | 12 |
| | 1+ | 0 | 1 | 49 | 0 | 0 | 50 |
| | Trace | 0 | 0 | 1 | 27 | 7 | 35 |
| | Neg | 0 | 0 | 0 | 2 | 371 | 373 |
| | Total | 39 | 13 | 50 | 29 | 378 | 509 |
| Agreement within same color block (Exact Match) | | 100.0% (31/31) | 100.0% (26/26) | 100.0% (22/22) | 87.5% (14/16) | 100.0% (414/414) | 99.61% (507/509) |
| Agreement within ±1 color block | | 100.0% (39/39) | 100.0% (12/13) | 100.0% (50/50) | 100.0% (29/29) | 100.0% (378/378) | 100.0% (509/509) |
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b. Matrix comparison:
Not applicable. Urine is the only sample matrix.
3. Clinical studies:
a. Clinical Sensitivity:
Not applicable.
b. Clinical specificity:
Not applicable.
c. Other clinical supportive data (when a. and b. are not applicable):
Not applicable.
4. Clinical cut-off:
Not applicable.
5. Expected values/Reference range:
The labeling states the following:
Glucose: Small amounts of glucose are normally excreted by the kidney. Concentrations as little as 0.1 g/dl glucose, read either at 10 or 30 seconds, may be significantly abnormal if found consistently. At 10 seconds, results should be interpreted qualitatively; for semi-quantitative results, read at 30 seconds only.
Bilirubin: Normally, no bilirubin is detectable in urine by even the most sensitive method. Even trace amounts of bilirubin are sufficiently abnormal to require further investigation. Atypical colors (colors produced which are different than the negative or positive color blocks shown on the Color Chart) may indicate that bilirubin derived bile pigments are present in the urine sample and are possibly masking the bilirubin reaction.
Ketone: Normally, no ketones are present in urine. Detectable levels of ketone may occur in urine during physiological stress conditions such as fasting, pregnancy, and frequent strenuous exercise. In starvation diets, or in other abnormal carbohydrate metabolism situation, ketones appear in the urine in excessively large amounts before serum ketones are elevated.
Specific Gravity: Random urine may vary in specific gravity from 1.003-1.040+. Twenty-four hour urine from normal adults with normal diets and normal fluid intake will have a specific gravity of 1.016-1.022.
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Blood: Any green spots or green color developing on the reagent area within 40 seconds is significant and the urine should be examined further. Blood is frequently, but not invariably found in the urine of menstruating females.
pH: The normal pH of urine can range from 4.5-8.0. The average pH values in healthy subjects is 6.0.³
Protein: In 24-hour urine, 1-14 mg/dl of protein may be excreted by the normal kidney.⁴ A color matching any color block greater than trace indicates significant proteinuria. For urine with high specific gravity, the test area may most closely match the trace color block even though only normal concentrations of protein are present. Clinical judgment is needed to evaluate the significance of trace results.
Urobilinogen: In a healthy population, the normal urine urobilinogen range obtained with this test is 0.2-1.0 Ehrlich Unit/dL. A result of 2.0 EU/dL may be of clinical significance and the same patient sample should be evaluated further.
Nitrite: Normally no detectable amount of nitrite is present in urine.³ The nitrite area will be positive in a proportion of cases of significant infection, depending on how long the urine specimens were retained in the bladder prior to collection. Retrieval of positive cases with the nitrite test range from as low as 40%, in instances where little bladder incubation occurred, to as high as 80% in instances where a minimum of 4 hours incubation occurred.
Leukocytes: Normal urine specimens generally yield negative results with this test. A trace result may be of questionable clinical significance and it is recommended that the test be repeated using a fresh sample from the same patient. Repeated trace and positive results are of clinical significance.
1. Free, A.H and Free, H.M.: Urinalysis, Critical Discipline of Clinical Science. CRC Crit. Rev. Clin. Lab. Sci. 3(4): 481-531; (1972).
2. Yoder, J.Adams, E.C., and Free. H.M.: Simultaneous Screening for Urinary Occult Blood, Protein, Glucose and pH. Amer. J. Med Tech. 31:285; (1965).
3. Tietz, N.W.: Clinical Guide to Laboratory Tests; W.B. Saunders Company, (1976).
4. Burtis, C.A. and Ashwood, E.R.: Tietz Textbook of Clinical Chemistry 2nd Ed. 2205; (1994).
5. Schersten, B. and Fritz, H.: Subnormal Levels of Glucose in Urine. JAMA 201:129-132; (1967).
6. McGarry, J.D.: Lilly Lecture, 1978: New Perspectives in the Regulation of Ketogenesis. Diabetes 28: 517-523 May, (1978).
7. Williamson, D.H.: Physiological ketoses, or Why Ketone Bodies? Postgrad. Med. J. (June Suppl.): 371-375: (1971).
8. Paterson, P. et al.: Maternal and Fetal Ketone Concentrations in Plasma and Urine. Lancet: 862-865; April 22, (1967).
9. Fraser, J. et al.: Studies with a Simplified Nitroprusside Test for Ketone Bodies in Urine, Serum, Plasma and Milk. Clin. Chem. Acta II: 372-378; (1965).
21
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10. Henry, J.B. et al.: Clinical Diagnosis and Management by Laboratory Methods, 16th Ed. Philadelphia: Saunders; (1979).
## P. Other Supportive Instrument Performance Characteristics Data Not Covered In The "Performance Characteristics" Section above:
### Flex Study – Temperature and Humidity
The environmental effect on the performance of the Uritek TC-201 Urine Chemistry Test System was evaluated by placing the test strips in relative humidity of <20%, 30%, 50%, 60% and 70% environment at 15°C and 45°C. Strips were removed at 0.5h, 1h, 2h, 4h, 8h, 16h and 24h for testing in triplicate using commercially available urine control solutions at Level I (High analyte concentration), Level II (Low analyte concentration) and Level III (Negative). The study results support the claim that the test strips are stable at 15-30°C (59-86°F) at 20-30% humidity.
### Flex Study – Timing of Urine Dip
A study was performed to demonstrate that there is no impact in results for Uritek TC-201 Urine Chemistry Test System when the strips are dipped in urine for 1-10 seconds. The labeling states that the dipping step should not exceed 10 seconds.
### Analyzer Operating Conditions Study
A study was performed to support the claim of acceptable operating conditions at 15-30°C and 18-80% Relative Humidity for the Uritek TC-201 Urine Analyzer. The performance of Uritek TC-201 Urine Chemistry Test System was evaluated by placing the Uritek TC-201 Urine analyzer in relative humidity of 92% at 30°C. These conditions were manufactured artificially in the Laminar Air Flow Cabinet by placing Hot Water Steam Bath and a Humidifier. Tests were performed at particular time-points at 0.1h, 8h, 16h and 24h using commercially available urine control solutions at Level I (High analyte concentration), Level II (Low analyte concentration) and Level III (Negative).
The Uritek TC-201 Urine Analyzer device complies with the applicable voluntary standards which include IEC 61010-1 and IEC 61010-2-101 for Electrical Safety and IEC 61326-1 and IEC 61326-2 for Electromagnetic Compatibility.
## 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.
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