URITEK TC-201 URINE CHEMISTRY TEST SYSTEM
Device Facts
| Record ID | K152835 |
|---|---|
| Device Name | URITEK TC-201 URINE CHEMISTRY TEST SYSTEM |
| Applicant | Teco Diagnostics, Inc. |
| Product Code | JFY · Clinical Chemistry |
| Decision Date | Mar 7, 2016 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 862.1225 |
| Device Class | Class 2 |
Indications for Use
Uritek TC-201 Urine Chemistry Test System consists of Uritek TC-201 Urine Analyzer and Urine Microalbumin Creatinine Strips. The Uritek TC-201 Urine Analyzer is an automated, bench top instrument which is intended for prescription, in vitro diagnostic use only. It is intended for use only at Point-of-Care (POC) sites by professionals. The device is intended to be used together with the Urine Microalbumin Creatinine (UAC) Strips as a system for the semiquantitative detection of Microalbumin and Creatinine and determination of the albumin to creatinine ratio in urine. Test results may be used in screening urine specimens for microalbuminuria as an aid in the detection of patients at risk for developing kidney damage.
Device Story
Uritek TC-201 is an automated, benchtop urinalysis system for professional POC use. It consists of the TC-201 analyzer and UAC reagent strips. The analyzer uses reflectance photometry to measure color intensity on reagent pads; it irradiates the strip with light and detects reflectance via photodiode. The system calculates microalbumin and creatinine concentrations and the albumin-to-creatinine ratio. Results are displayed on a touchscreen and printed via an internal thermal printer. The device aids clinicians in screening for microalbuminuria to identify patients at risk for kidney damage. It features a serial/USB interface for data management and stores up to 2000 results.
Clinical Evidence
No clinical studies performed. Performance established via bench testing and method comparison study. Method comparison tested 402 patient samples and 38 contrived samples (total 518) across three POC sites. Results showed high agreement with predicate device; exact agreement for albumin and creatinine ranged from 77.8% to 91.4% across blocks, with 100% agreement within ±1 block.
Technological Characteristics
Reflectance photometer; uses bibulous material reagent strips with dye-binding (microalbumin) and peroxidase-like copper complex (creatinine) chemistry. Self-calibration via white strip area. Power: 100-240V AC. Connectivity: RS232/USB. Dimensions: 7.25" x 10.5" x 6.5". Weight: 1.88kg. Software-controlled analysis.
Indications for Use
Indicated for professional use at Point-of-Care (POC) sites for the semiquantitative detection of microalbumin and creatinine and determination of albumin-to-creatinine ratio in urine specimens to screen for microalbuminuria as an aid in detecting patients at risk for kidney damage.
Regulatory Classification
Identification
A creatinine test system is a device intended to measure creatinine levels in plasma and urine. Creatinine measurements are used in the diagnosis and treatment of renal diseases, in monitoring renal dialysis, and as a calculation basis for measuring other urine analytes.
Predicate Devices
- Clinitek Status Plus Analyzer and Siemens Reagent Strips for Urinalysis (k091216)
Related Devices
- K160372 — URITEK TC-201 URINE CHEMISTRY TEST SYSTEM · Teco Diagnostics, Inc. · Jul 22, 2016
- K142391 — Mission U120 Ultra Urine Analyzer, Mission Urinalysis Reagent Strips ( Microalbumin/Creatinine ) · ACON Laboratories, Inc. · Dec 22, 2014
Submission Summary (Full Text)
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# 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY AND INSTRUMENT COMBINATION TEMPLATE
A. 510(k) Number:
k152835
B. Purpose for Submission:
New device
C. Measurand:
Urine Creatinine and Albumin
D. Type of Test:
Semi-quantitative colorimetric reagent strip test
E. Applicant:
Teco Diagnostics, Inc.
F. Proprietary and Established Names:
Uritek TC-201 Urine Chemistry Test System
G. Regulatory Information:
| Product Code | Classification | Regulation Section | Panel |
| --- | --- | --- | --- |
| JFY | II | 21 CFR §862.1225
Creatinine test system | Chemistry (75) |
| JIR | I | 21 CFR §862.1645
Urinary protein or albumin (nonquantitative) test system | Chemistry (75) |
| KQO | I | 21 CFR §862.2900
Automated Urinalysis System | Chemistry (75) |
H. Intended Use:
1. Intended use(s):
Uritek TC-201 Urine Chemistry Test System consists of Uritek TC-201 Urine Analyzer and Urine Microalbumin Creatinine Strips. The Uritek TC-201 Urine Analyzer is an
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automated, bench top instrument which is intended for prescription, in vitro diagnostic use only. It is intended for use only at Point-of-Care (POC) sites by professionals. The device is intended to be used together with the Urine Microalbumin Creatinine (UAC) Strips as a system for the semi-quantitative detection of Microalbumin and Creatinine and determination of the albumin to creatinine ratio in urine. Test results may be used in screening urine specimens for microalbuminuria as an aid in the detection of patients at risk for developing kidney damage.
2. Indication(s) for use:
See above
3. Special conditions for use statement(s):
For prescription use only. For point-of-care use.
Test strips are not intended for visual read
4. Special instrument requirements:
Uritek TC-201 Urine Analyzer
I. Device Description:
Uritek TC-201 Urine Chemistry Test System consists of Uritek TC-201 Urine Analyzer and Urine Microalbumin Creatinine Strips. The Uritek TC-201 Urine Analyzer (TC-201) is a portable instrument which reads Teco Diagnostics' Urine Microalbumin Creatinine (UAC) Strips. The analyzer can determine the intensity of different colors on the reagent strip test area. It does this by irradiating the test area with light and detecting the reflectance of different wavelengths using 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 assays for microalbumin and creatinine. 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 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.
The Urine Microalbumin Creatinine (UAC) Strips are urine test strips of which microalbumin and creatinine reagent pad are affixed onto the firm plastic strips. The reagent pad areas are bibulous material saturated with chemically active substances, then dried and affixed to the plastic strip with double-sided adhesive. UAC strips provide tests for the semi-quantitative detection of Microalbumin and Creatinine and determination of the Albumin to Creatinine ratio (A:C) in urine.
J. Substantial Equivalence Information:
1. Predicate device name(s):
CLINITEK Status+ Analyzer and Siemens Reagent Strips for Urinalysis
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2. Predicate 510(k) number(s): k091216
3. Comparison with predicate:
| Similarities and Differences | | |
| --- | --- | --- |
| Item | Proposed device Uritek TC-201 Urine Chemistry Test System | Predicate CLINITEK Status+ Analyzer and Siemens Reagent Strips for Urinalysis |
| Intended Use | For the semi-quantitative measurement of Albumin and Creatinine in urine at point-of-care sites. Results may be used as an aid in the detection of patients at risk for developing kidney damage. | Same |
| Methodology | Reflectance Photometer | Same |
| Specimen Type | Urine | Same |
| Analytical Method | The analyzer measures the intensity of the light reflected from the reagent pads of a urinalysis reagent strip. | Same |
| Analytes | Microalbumin, Creatinine | Microalbumin, Creatinine, Bilirubin, Blood (Occult), Glucose, Ketone, Leukocytes, Nitrite, pH, Protein, Specific Gravity, Urobilinogen, and human Chorionic Gonadotropin (hCG) |
| Calculated Parameter | Albumin : Creatinine Ratio | Same |
| Calibration Method | Self-calibration with the white area located at the back of the test strip bed | Same |
| Analyzer Operating Conditions | 64-86°F (18-30°C); 18%-80% RH | Same |
| Chemistry Strips | Urine Microalbumin and Creatinine (UAC) Strips | Siemens Reagent Strips for Urinalysis |
| Battery Powered Operation | None | 6 AA batteries |
| Memory | Store up to 2000 test results | Store up to 950 test results |
| Analyzer Dimensions | Width 7.25 in | Width 6.7 in |
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| Similarities and Differences | | |
| --- | --- | --- |
| Item | Proposed device
Uritek TC-201 Urine Chemistry Test System | Predicate
CLINITEK Status+ Analyzer and Siemens Reagent Strips for Urinalysis |
| | Depth 10.5 in
Height 6.5 in | Depth 10.7 in
Height 6.2 in |
| Analyzer Weight | 4.14 lbs (1.88kg) | 3.65 lbs (1.66kg) |
| Measuring range | 10mg/L to 150mg/L for Albumin
10mg/dL to 300mg/dL for Creatinine | Same |
| Test strip storage conditions | 15-30°C | Same |
## K. Standard/Guidance Document Referenced (if applicable)
CLSI EP07-A2: Interference Testing in Clinical Chemistry
## L. Test Principle:
The Uritek TC-201 Urine Analyzer is a reflectance photometer that analyzes the intensity and color of light reflected from the reagent areas of a urinalysis reagent strip. Using a light emitting diode (LED) as the light source and a light sensor, the optical system reads the color change in the urine test strips after a sample is applied.
**Microalbumin**: Indicator method based on dye binding using a high affinity sulfonephthalein dye. At a constant pH, the development of a blue color is due to the presence of Microalbumin. The resulting color ranges from pale green to aqua blue.
**Creatinine**: Indicator method based on the peroxidase-like activity of a copper creatinine complex that catalyze the reaction of diisopropylbenzene dihydroperoxide and 3', 3', 5', 5' - tetramethylbenzidine. The resulting color ranges from orange through green to blue.
## M. Performance Characteristics (if/when applicable):
### 1. Analytical performance:
#### a. Precision/Reproducibility:
To evaluate between-run precision, 3 levels of albumin and creatinine in contrived urine samples were tested at 3 sites with the Uritek TC-201 Urine Chemistry Test system using three lots of strips and 3 analyzers. Each sample was assayed by three POC operators at each site, twice a day for 20 days. To evaluate within run precision, 3 levels of albumin and creatinine in contrived urine samples were tested at 3 sites
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with three lots of strips on 3 analyzers. Each sample was tested in 20 replicates in one day.
The exact match block agreement results from each of the 3 POC sites are:
POC Site 1:
| Analyte | Concentration | Result (Exact Match/Total) | | |
| --- | --- | --- | --- | --- |
| | | Operator 1 | Operator 2 | Operator 3 |
| Albumin | 10mg/L | 14/14 | 13/13 | 13/13 |
| | 30 mg/L | 14/14 | 13/13 | 13/13 |
| | 150 mg/L | 14/14 | 13/13 | 13/13 |
| Creatinine | 10 mg/dL | 13/14 | 13/13 | 13/13 |
| | 50 mg/dL | 14/14 | 13/13 | 12/13 |
| | 300 mg/dL | 14/14 | 13/13 | 13/13 |
POC Site 2:
| Analyte | Concentration | Result (Exact Match/Total) | | |
| --- | --- | --- | --- | --- |
| | | Operator 1 | Operator 2 | Operator 3 |
| Albumin | 10mg/L | 14/14 | 13/13 | 13/13 |
| | 30 mg/L | 14/14 | 13/13 | 13/13 |
| | 150 mg/L | 13/14 | 13/13 | 13/13 |
| Creatinine | 10 mg/dL | 14/14 | 13/13 | 13/13 |
| | 50 mg/dL | 14/14 | 13/13 | 13/13 |
| | 300 mg/dL | 14/14 | 12/13 | 13/13 |
POC Site 3:
| Analyte | Concentration | Result (Exact Match/Total) | | |
| --- | --- | --- | --- | --- |
| | | Operator 1 | Operator 2 | Operator 3 |
| Albumin | 10mg/L | 14/14 | 13/13 | 13/13 |
| | 30 mg/L | 14/14 | 13/13 | 13/13 |
| | 150 mg/L | 14/14 | 13/13 | 13/13 |
| Creatinine | 10 mg/dL | 14/14 | 13/13 | 13/13 |
| | 50 mg/dL | 14/14 | 13/13 | 13/13 |
| | 300 mg/dL | 14/14 | 13/13 | 13/13 |
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The combined precision data for the three POC sites are:
| Analyte | Conc | | Total Agreement within same block | Total Agreement within ± 1 block |
| --- | --- | --- | --- | --- |
| Albumin | 10 mg/L | Within-run | 60/60 100% | 60/60 100% |
| | | Between run | 120/120 100% | 120/120 100% |
| | 30 mg/L | Within-run | 60/60 100% | 60/60 100% |
| | | Between run | 119/120 99.2% | 120/120 100% |
| | 150 mg/L | Within-run | 60/60 100% | 60/60 100% |
| | | Between run | 119/120 99.2% | 120/120 100% |
| | 10 mg/dL | Within-run | 60/60 100% | 60/60 100% |
| | | Between run | 119/120 99.2% | 120/120 100% |
| Creatinine | 50 mg/dL | Within-run | 60/60 100% | 60/60 100% |
| | | Between run | 119/120 99.2% | 120/120 100% |
| | 300 mg/dL | Within-run | 60/60 100% | 60/60 100% |
| | | Between run | 119/120 99.2% | 120/120 100% |
| | 10 mg/dL | Within-run | 60/60 100% | 60/60 100% |
| | | Between run | 119/120 99.2% | 120/120 100% |
# b. Linearity/assay reportable range:
This assay reports color block outputs of $10\mathrm{mg / L}$ , $30\mathrm{mg / L}$ , $80\mathrm{mg / L}$ , $150\mathrm{mg / L}$ for albumin, and $10\mathrm{mg / dL}$ , $50\mathrm{mg / dL}$ , $100\mathrm{mg / dL}$ , $200\mathrm{mg / dL}$ , $300\mathrm{mg / dL}$ for creatinine.
# c. Traceability, Stability, Expected values (controls, calibrators, or methods):
No calibrators or controls are being cleared with this submission.
# Stability:
Open bottle study, stressed stability study and real-time shelf-life study were conducted to evaluate stability of the test strips. The study protocols and acceptance criteria were reviewed and found acceptable. Stability data support the following manufacturer's claim: The strip can be stored in $15^{\circ}\mathrm{C}$ to $30^{\circ}\mathrm{C}$ ( $60^{\circ}\mathrm{F}$ to $86^{\circ}\mathrm{F}$ ) in closed package to 24 months, opened package stable for at least 3 months from the manufacture date at room temperature ( $60^{\circ}\mathrm{F}$ to $86^{\circ}\mathrm{F}$ ). The real-time shelf-life study is ongoing.
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d. Detection limit:
The cutoff of the assay at each color block was evaluated by spiking or diluting urine samples to known concentrations. For each analyte there is a minimum of three levels across the measuring range of each color block. Each sample was tested by three operators with 3 lots of strips for 3 days. The cutoff for each block is defined as the lowest concentration at which $>50\%$ of the results are positive for each color block.
The cut-off values for each color block are summarized below:
| Analyte | Color Block | Low Cut-off Concentration | % Positive results |
| --- | --- | --- | --- |
| Albumin | 10 mg/L | 0 mg/L | 100% |
| | 30 mg/L | 20 mg/L | 66.7% |
| | 80 mg/L | 55 mg/L | 53.3% |
| | 150 mg/L | 125 mg/L | 60% |
| Creatinine | 10 mg/dL | 0 mg/dL | 100% |
| | 50 mg/dL | 30 mg/dL | 73.3% |
| | 100 mg/dL | 75 mg/dL | 60% |
| | 200 mg/dL | 150 mg/dL | 53.3% |
| | 300 mg/dL | 250 mg/dL | 66.7% |
Results for each level tested at each color block are shown below:
Albumin:
| | Percentage Agreement at Each Color Block | | | |
| --- | --- | --- | --- | --- |
| Conc. Tested | 10 mg/L | 30 mg/L | 80 mg/L | 150 mg/L |
| 300 mg/L | 0% | 0% | 0% | 100% |
| 225 mg/L | 0% | 0% | 0% | 100% |
| 150 mg/L | 0% | 0% | 0% | 100% |
| 132.5 mg/L | 0% | 0% | 0% | 86.7% |
| 125 mg/L | 0% | 0% | 0% | 60% |
| 115 mg/L | 0% | 0% | 46.7% | 33.3% |
| 97.5 mg/L | 0% | 0% | 66.7% | 0% |
| 80 mg/L | 0% | 0% | 100% | 0% |
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| | Percentage Agreement at Each Color Block | | | |
| --- | --- | --- | --- | --- |
| Conc. Tested | 10 mg/L | 30 mg/L | 80 mg/L | 150 mg/L |
| 67.5 mg/L | 0% | 6.7% | 93.3% | 0% |
| 55 mg/L | 0% | 46.7% | 53.3% | 0% |
| 42.5 mg/L | 26.7% | 66.7% | 33.3% | 0% |
| 30 mg/L | 0% | 100% | 0% | 0% |
| 25 mg/L | 26.7% | 73.3% | 0% | 0% |
| 20 mg/L | 33.3% | 66.7% | 0% | 0% |
| 15 mg/L | 80% | 20% | 0% | 0% |
| 10 mg/L | 100% | 0% | 0% | 0% |
| 5 mg/L | 100% | 0% | 0% | 0% |
| 2.5 mg/L | 100% | 0% | 0% | 0% |
Creatinine:
| | Percentage Agreement at Each Color Block | | | | |
| --- | --- | --- | --- | --- | --- |
| Conc. Tested | 10 mg/dL | 50 mg/dL | 100 mg/dL | 200 mg/dL | 300 mg/dL |
| 600 mg/L | 0% | 0% | 0% | 0% | 100% |
| 425 mg/L | 0% | 0% | 0% | 0% | 100% |
| 300 mg/L | 0% | 0% | 0% | 0% | 100% |
| 275 mg/L | 0% | 0% | 0% | 0% | 86.7% |
| 250 mg/L | 0% | 0% | 0% | 33.3% | 66.7% |
| 225 mg/L | 0% | 0% | 0% | 73.3% | 26.7% |
| 200 mg/L | 0% | 0% | 0% | 100% | 0% |
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| | Percentage Agreement at Each Color Block | | | | |
| --- | --- | --- | --- | --- | --- |
| Conc. Tested | 10 mg/dL | 50 mg/dL | 100 mg/dL | 200 mg/dL | 300 mg/dL |
| 175 mg/L | 0% | 0% | 20% | 80% | 0% |
| 150 mg/L | 0% | 0% | 46.7% | 53.3% | 0% |
| 125 mg/L | 0% | 0% | 86.7% | 13.3% | 0% |
| 100 mg/L | 0% | 0% | 100% | 0% | 0% |
| 87.5 mg/L | 0% | 26.7% | 73.3% | 0% | 0% |
| 75 mg/L | 0% | 40% | 60% | 0% | 0% |
| 62.5 mg/L | 0% | 73.3% | 26.7% | 0% | 0% |
| 50 mg/L | 0% | 100% | 0% | 0% | 0% |
| 40 mg/L | 20% | 80% | 0% | 0% | 0% |
| 30 mg/L | 27.7% | 73.3% | 0% | 0% | 0% |
| 20 mg/L | 66.7% | 33.3% | 0% | 0% | 0% |
| 10 mg/L | 100% | 0% | 0% | 0% | 0% |
| 5 mg/L | 100% | 0% | 0% | 0% | 0% |
| 2.5 mg/L | 100% | 0% | 0% | 0% | 0% |
e. Analytical specificity:
Interference studies were performed to evaluate the effects of potential interferents commonly found in urine on the performance of the test system, following CLSI EP7-A2. Testing was done with contrived urine samples at 3 levels of albumin (10, 30, 150 mg/L) and creatinine (10, 100, 300 mg/dL) and at least two levels of the listed compounds with 3 lots of the test strips. Interference was defined as a change in output of $\geq \pm 1$ color blocks between spiked and unspiked samples.
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Summary:
| Interferent | Conc. Tested | Interference on the Testing Result Result of Albumin | | | Result of Creatinine | | |
| --- | --- | --- | --- | --- | --- | --- | --- |
| | | 10 mg/ | 30 mg/ | 150 mg/L | 10 mg/ | 100 mg/d | 300 mg/d |
| Ammonium Chloride | 100 mg/dL | -- | -- | -- | -- | -- | -- |
| Ascorbic acid | 200 mg/dL | -- | -- | -- | -- | -- | -- |
| Bilirubin | 175 mg/dL | -- | -- | -- | -- | -- | -- |
| Bovine serum | 10g/L | N/A | N/A | N/A | -- | -- | -- |
| Caffeine | 2g/dL | -- | -- | -- | -- | -- | -- |
| Calcium chloride | 275 mg/dL | -- | -- | -- | -- | -- | -- |
| Ciprofloxacin | 500mg/L | -- | -- | -- | -- | -- | -- |
| Citric acid | 75 mg/dL | -- | -- | -- | -- | -- | -- |
| Creatine | 10 mg/dL | -- | -- | -- | -- | -- | -- |
| Creatinine | 600 mg/dL | -- | -- | -- | N/A | N/A | NA |
| Fructose | 100 mg/dL | -- | -- | -- | -- | -- | -- |
| Galactose | 80 mg/dL | -- | -- | -- | -- | -- | -- |
| Glucose | 5000 mg/dL | -- | -- | -- | -- | -- | -- |
| Glycine | 225 mg/dL | -- | -- | -- | -- | -1 | -1 |
| Hemoglobin | 10 mg/dL | +1 | +1 | -- | +1 | +1 | -- |
| Lactose | 10 mg/dL | -- | -- | -- | -- | -- | -- |
| Lithium acetoacetate | 250 mg/dL | -- | -- | -- | -- | -- | -- |
| Oxalic acid | 70 mg/dL | -- | -- | -- | -- | -- | -- |
| Phenolphthalein | 1200 mg/dL | -- | -- | -- | -- | -- | -- |
| Potassium chloride | 1500 mg/dL | -- | -1 | -2 | -- | -- | -- |
| Riboflavin | 200 mg/dL | -- | -- | -- | -- | -- | -- |
| Sodium acetate | 2.25 mg/dL | -- | -- | -- | -- | -- | -- |
| Sodium bicarbonate | 750mg/dL | +1 | +1 | -- | -- | -1 | -2 |
| Sodium chloride | 5500 mg/dL | -- | -1 | -2 | +3 | +2 | -- |
| Sodium nitrate | 10 mg/dL | -- | -- | -- | -- | -- | -- |
| Sodium nitrite | 10 mg/dL | -- | -- | -- | -- | -- | -- |
| Sodium phosphate | 500 mg/dL | -- | -- | -- | -- | -- | -- |
| Theophylline | 100 mg/dL | -- | -- | -- | -- | -- | -- |
| Urea | 400 mg/dL | -- | -- | -- | -- | -- | -- |
| Uric acid | 150 mg/dL | -- | -- | -- | -- | -- | -- |
| Blood | 0.05% | +2 | +1 | -- | +1 | +1 | -- |
| Leucocyte | 5000 leu/uL | -- | -- | -- | -- | -- | -- |
| Human IgG | 50 mg/dL | +1 | +1 | -- | -- | -- | -- |
*-- indicates that the no interference was observed at these interferent and analyte levels.
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The sponsor includes the following table to summarize the substance and concentrations that could interfere with the test of albumin and creatinine on Uritek TC-201 Urine Analyzer.
| Analyte | Substances causing decreased results | Substances causing increased results |
| --- | --- | --- |
| Albumin | Potassium chloride (1500 mg/dL)
Sodium chloride (5500 mg/dL) | Hemoglobin (10 mg/dL)
Sodium bicarbonate (750 mg/dL)
Blood (0.05%)
Human IgG (50 mg/dL) |
| Creatinine | Glycine (225 mg/dL)
Sodium bicarbonate (750 mg/dL) | Hemoglobin (10 mg/dL)
Sodium chloride (5500 mg/dL)
Blood (0.05%) |
Urine pH Interference Study:
Urine pH was evaluated for potential interference. Negative random urine samples were collected, pooled and divided into 7 portions. The pH of each portion was adjusted from 4 to 10, then spiked with albumin or creatinine to 3 concentrations. Samples were tested using 3 lots of test strips and one analyzer. The evaluation of urine pH showed no effect on the test results for albumin and creatinine.
Urine SG Interference Study:
Specific gravity of urine samples that were confirmed with refractometer as 1.005, 1.010, 1.020 and 1.030 were tested for potential interference with creatinine test results. Creatinine readouts from the Uritek TC-201 Urine Chemistry Test System were 50mg/dL, 100mg/dL, 200mg/dL and 300mg/dL respectively. The results were consistent with results obtained from a reference method showing no abnormal effect by SG on the creatinine result.
When urine samples at different specific gravity were spiked with albumin, results showed no inference in albumin readouts from Uritek TC-201 Urine Analyzer using Urine Microalbumin Creatinine (UAC) strips.
The sponsor states the following in the labeling regarding potentially interfering substances:
1. The presence of hemoglobin (≥10 mg/dL or visibly bloody urine) may cause falsely elevated results with both albumin and creatinine tests. The presence of potassium chloride (≥1500mg/dL) could cause decreased results with albumin test.
The presence of glycine (≥225mg/dL) could cause decreased results with creatinine test. Sodium biocarbonate above 750mg/dL could affect the results of both microalbumin and creatinine tests.
2. Substances that cause abnormal urine color, such as drug containing azo dyes (e.g., Pyridium, AZO Gantrisin, AZO Gantanol), nitrofurantoin (Macrodantin, Furadantin) and riboflavin may affect the readability of the reagent areas on urinalysis reagent strips.
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3. Urinary albumin excretions can be elevated by exercise, urinary tract infections, and acute illness with fever. It is recommended that individuals avoid strenuous exercise prior to testing.
4. As with laboratory tests, definitive diagnostic or therapeutic decisions should not be based on a single result or method.
## Humidity Studies:
The environmental effect on the performance of 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 using contrived urine samples at 3 levels of microalbumin (10, 30, 150mg/L) and creatinine (10, 50, 300mg/dL). 5 replicates were tested for each level. The test strips were stable up to 50% humidity for over 24h at either 15°C or 45°C. When humidity is above 60%, the test strips were stable for 8h when stored at 15°C and for 4hr when stored at 45°C.
## Timing Flex Study:
The effect of various dipping time in urine samples was evaluated for the performance of the Uritek TC-201 Urine Chemistry Test System. The strip was dipped in the urine samples for 1 second, 5 seconds and 10 seconds before removed for testing. Contrived urine samples at 3 levels of microalbumin (10, 30, 150mg/L) and creatinine (10, 50, 300mg/dL) were tested. Each sample was tested in 5 replicates. Study results showed that dipping time had no effect on the test results.
## Sample Carryover Studies:
The potential interference of samples running over from one pad to the adjacent pad on the performance of Uritek TC-201 Urine Chemistry Test System was evaluated. The strip was dipped into a urine sample and upon removal, was held upward to allow the sample flow from the microalbumin pad to the creatinine pad or held downward to allow the sample flow from the microalbumin pad to the creatinine pad before testing. Contrived urine samples at 3 levels of microalbumin (10, 30, 150mg/L) and creatinine (10, 50, 300mg/dL) were tested. Each holding method was tested in 5 replicates. Study results showed that sample running over from one test pad had no interfering effect on the test of the other pad.
f. Assay cut-off:
See detection limits (M. 1. d.) above.
## 2. Comparison studies:
a. Method comparison with predicate device:
Three point-of-care (POC) sites that represented the intended user sites of these devices were selected to perform the method comparison studies. Each site randomly selected at least 120, unaltered patient samples to test on both device pairings
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(proposed and predicate devices). In addition, 38 contrived samples (9%) were generated to cover the measuring range of the test. In total, 402 specimens were tested. Three lots of test strips and 3 analyzers were used in the study.
The study results are presented in the tables below:
| Albumin (Site 1, n= 175) | Predicate Device | | | | |
| --- | --- | --- | --- | --- | --- |
| | | 10 mg/L | 30 mg/L | 80 mg/L | 150 mg/L |
| TECO | 10 mg/L | 53 | 0 | 0 | 0 |
| | 30 mg/L | 5 | 26 | 4 | 0 |
| | 80 mg/L | 0 | 5 | 44 | 3 |
| | 150 mg/L | 0 | 0 | 6 | 29 |
| Total | | 58 | 31 | 54 | 32 |
| Exact Agreement | | 91.4% | 83.9% | 81.5% | 91% |
| Agreement within ± 1 block | | 100% | 100% | 100% | 100% |
| Albumin (Site 2, n= 163) | Predicate Device | | | | |
| --- | --- | --- | --- | --- | --- |
| | | 10 mg/L | 30 mg/L | 80 mg/L | 150 mg/L |
| TECO | 10 mg/L | 47 | 1 | 0 | 0 |
| | 30 mg/L | 9 | 28 | 2 | 0 |
| | 80 mg/L | 0 | 7 | 33 | 4 |
| | 150 mg/L | 0 | 0 | 5 | 27 |
| Total | | 56 | 36 | 40 | 31 |
| Exact Agreement | | 83.9% | 77.8% | 82.5% | 87.1% |
| Agreement within ± 1 block | | 100% | 100% | 100% | 100% |
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| Albumin (Site 3, n= 180) | Predicate Device | | | | |
| --- | --- | --- | --- | --- | --- |
| | | 10 mg/L | 30 mg/L | 80 mg/L | 150 mg/L |
| TECO | 10 mg/L | 59 | 6 | 0 | 0 |
| | 30 mg/L | 10 | 32 | 1 | 0 |
| | 80 mg/L | 0 | 1 | 34 | 6 |
| | 150 mg/L | 0 | 0 | 3 | 28 |
| Total | | 69 | 39 | 38 | 34 |
| Exact Agreement | | 85.5% | 82.1% | 89.5% | 82 % |
| | | 100% | 100% | 100% | 100% |
| Creatinine (Site 1, n= 175) | Predicate Device | | | | | |
| --- | --- | --- | --- | --- | --- | --- |
| | | 10 mg/dL | 50 mg/dL | 100 mg/dL | 200 mg/dL | 300 mg/dL |
| TECO | 10 mg/dL | 10 | 4 | 0 | 0 | 0 |
| | 50 mg/dL | 1 | 47 | 3 | 0 | 0 |
| | 100 mg/dL | 0 | 3 | 21 | 7 | 0 |
| | 200 mg/dL | 0 | 0 | 3 | 40 | 6 |
| | 300 mg/dL | 0 | 0 | 0 | 4 | 26 |
| Total | | 11 | 54 | 27 | 51 | 32 |
| Exact Agreement | | 90.9% | 87.0% | 77.8% | 78.4% | 81.3% |
| Agreement within ± 1 block | | 100% | 100% | 100% | 100% | 100% |
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| Creatinine (Site 2, n= 163) | Predicate Device | | | | | |
| --- | --- | --- | --- | --- | --- | --- |
| | | 10 mg/dL | 50 mg/dL | 100 mg/dL | 200 mg/dL | 300 mg/dL |
| TECO | 10 mg/dL | 8 | 5 | 0 | 0 | 0 |
| | 50 mg/dL | 2 | 44 | 2 | 0 | 0 |
| | 100 mg/dL | 0 | 4 | 24 | 7 | 0 |
| | 200 mg/dL | 0 | 0 | 2 | 38 | 4 |
| | 300 mg/dL | 0 | 0 | 0 | 3 | 20 |
| Total | | 10 | 53 | 28 | 48 | 24 |
| Exact Agreement | | 80.0% | 83.0% | 85.7% | 79.2% | 83.3% |
| Agreement within ± 1 block | | 100% | 100% | 100% | 100% | 100% |
| Creatinine (Site 3, n= 180) | Predicate Device | | | | | |
| --- | --- | --- | --- | --- | --- | --- |
| | | 10 mg/dL | 50 mg/dL | 100 mg/dL | 200 mg/dL | 300 mg/dL |
| TECO | 10 mg/dL | 17 | 2 | 0 | 0 | 0 |
| | 50 mg/dL | 3 | 51 | 5 | 0 | 0 |
| | 100 mg/dL | 0 | 4 | 28 | 3 | 0 |
| | 200 mg/dL | 0 | 0 | 2 | 35 | 5 |
| | 300 mg/dL | 0 | 0 | 0 | 2 | 23 |
| Total | | 20 | 57 | 35 | 40 | 28 |
| Exact Agreement | | 85.0% | 89.5% | 80.0% | 87.5% | 82.1% |
| Agreement within ± 1 block | | 100% | 100% | 100% | 100% | 100% |
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For all three sites combined:
| Albumin (n= 518) | Predicate Device | | | | |
| --- | --- | --- | --- | --- | --- |
| | | 10 mg/L | 30 mg/L | 80 mg/L | 150 mg/L |
| TECO | 10 mg/L | 159 | 7 | 0 | 0 |
| | 30 mg/L | 24 | 86 | 7 | 0 |
| | 80 mg/L | 0 | 13 | 111 | 13 |
| | 150 mg/L | 0 | 0 | 14 | 84 |
| Total | | 183 | 106 | 132 | 97 |
| Exact Agreement | | 86.9% | 81.1% | 84.1% | 87.0% |
| Agreement within ± 1 block | | 100% | 100% | 100% | 100% |
| Creatinine (n= 518) | Predicate Device | | | | | |
| --- | --- | --- | --- | --- | --- | --- |
| | | 10 mg/dL | 50 mg/dL | 100 mg/dL | 200 mg/dL | 300 mg/dL |
| TECO | 10 mg/dL | 35 | 11 | 0 | 0 | 0 |
| | 50 mg/dL | 6 | 142 | 10 | 0 | 0 |
| | 100 mg/dL | 0 | 11 | 73 | 17 | 0 |
| | 200 mg/dL | 0 | 0 | 7 | 113 | 15 |
| | 300 mg/dL | 0 | 0 | 0 | 9 | 69 |
| Total | | 41 | 164 | 90 | 139 | 84 |
| Exact Agreement | | 85.4% | 86.6% | 81.1% | 81.3% | 82.1% |
| Agreement within ± 1 block | | 100% | 100% | 100% | 100% | 100% |
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Albumin: creatinine ratio for all three sites combined:
| A:C | Predicate Device | | | | |
| --- | --- | --- | --- | --- | --- |
| | | <30 | 30-300 | >300 | Total |
| TECO | <30 | 245 | 19 | 0 | 264 |
| | 30-300 | 18 | 136 | 10 | 164 |
| | >300 | 0 | 6 | 84 | 90 |
| | Total | 263 | 161 | 94 | 518 |
| Agreement at same block | | 93.2% | 84.5% | 89.4% | |
| Agreement within ±1 block | | 100% | 100% | 100% | |
The agreement of albumin to creatinine ratios of positive and negatives at cutoff of <30 mg/g were 92.5% (236/255) and 93.2% (245/263) respectively. Of the 255 positive results, 7.5% (19/255) were negative. Of the 263 assays, albumin to creatinine ratio negative results, 6.8% (18/263) were positive. In summary, the overall exact agreement between Uritek TC-201 Urine Chemistry Test System and the predicate for positive albumin results was 89.8%, and the overall agreement for ±1 block was 100%.
b. Matrix comparison:
Not applicable
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. Clinical studies are not typically submitted for this device type.
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5. Expected values/Reference range:
The expected values are included in the labeling and are taken from literature references.
Albumin: Normal albumin levels in random urine are under 20 mg/L. Microalbuminuria is indicated as the result of albumin excretion rate of 30-300 mg/24 hours. Values above 300 mg/L indicate clinical albuminuria. The detection of albuminuria at levels at or above 30 mg/L will help clinicians to better diagnose diabetes in its early stages¹.
Creatinine: Creatinine is normally present in random urine in concentrations of 10 to 300 mg/dL (0.9 to 26.5 mmol/L).
Albumin/Creatinine Ratio: Albumin is normally present in urine at concentrations of less than 30 mg albumin / g creatinine (<3.4 mg/mmol). Microalbuminuria is indicated at a ratio result of 30-300 mg/g (3.4-33.9 mg/mmol) (Abnormal) and clinical albuminuria at a ratio result of >300 mg/g (>33.9 mg/mmol) (High Abnormal)¹.
1. Levey AS, Coresh J, Balk E, et al. National Kidney Foundation practice guidelines for chronic kidney disease: evaluation, classification, stratification. Ann Intern Med. 139:137-147; 2003.
2. Hillege HL, Fidler V, Diercks G, et al. Urinary albumin excretion predict cardiovascular and noncardiovascular mortality in general population. Circulation. 106:1777-1782; 2002.
3. Mogensen, C.E.: Microalbuminuria Predicts Clinical Proteinuria and Early Mortality in Maturity-Onset Diabetes. N. Eng. J. Med. 310: 356-360; 1984.
4. Mujais SK. Marked proteinuria in hypertensive nephrosclerosis, Am J Nephrol, 5 (3), p190-5, 1985.
5. Dodama, K. et al.: The Range of Albumin Concentrations in the Single-Void First morning Urine of 1090 Healthy Young Children. Diab. Research Clin. Prac. 9:55-58; 1990.
6. Position Statement: Diabetic Nephropathy. Diabetes Care 20: S24-S27; 1997.
N. Instrument Name:
The Uritek TC-201 Urine Analyzer
O. System Descriptions:
1. Modes of Operation:
The Uritek TC-201 software system is preloaded into the Uritek TC-201 Urine Analyzer. No additional software installation requirement is needed. Once the Uritek TC-201 Urine Analyzer connects to the computer, it can send the testing results to the LIS system.
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Does the applicant's device contain the ability to transmit data to a computer, webserver, or mobile device?
Yes ☐ x ☐ or No ☐
Does the applicant's device transmit data to a computer, webserver, or mobile device using wireless transmission?
Yes ☐ or No ☐ x ☐
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:
A barcode scanner and manual entry of sample numbers are used for sample identification.
4. Specimen Sampling and Handling:
The keypad on the screen or a barcode scanner is used to enter the barcode from the strip bottle. The Uritek TC-201 Urine Analyzer can only accept one test strip at a time. Test strips are dipped in urine, and read on the analyzer. The analyzer also stores up to 2000 patient results which can be recalled by the patients' ID, date or operators (using "Advanced" settings by which is possible to add or remove authorized operators, change operator permissions, and perform quality control testing).
5. Calibration:
The instrument starts a 10 seconds of self-calibration after pressing the START button when running a Urinalysis Strip Quick Test. The device calibrates by reading a reference block located at the end of the test strip bed using the appropriate LED light during each strip test to ensure the accurate test result.
6. Quality Control:
The instrument includes a quality control function (QC). When the QC function is enabled, the instrument will ask for control testing during the system initialization prior to the routine testing run.
P. Other Supportive Instrument Performance Characteristics Data Not Covered In The "Performance Characteristics" Section above:
The Uritek TC-201 Urine Analyzer demonstrates compliance to EMC requirements including general requirements for laboratory use by meeting EN 61326-1 as well as requirements for
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in vitro diagnostic medical equipment by meeting EN 61326-2-6.
**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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