TC-THUNDERBOLT AUTOMATED URINE ANALYZER SYSTEM AND TC-THUNDERBOLT URS-10 STRIPS
Device Facts
| Record ID | K141289 |
|---|---|
| Device Name | TC-THUNDERBOLT AUTOMATED URINE ANALYZER SYSTEM AND TC-THUNDERBOLT URS-10 STRIPS |
| Applicant | Teco Diagnostics |
| Product Code | JIL · Clinical Chemistry |
| Decision Date | Jul 24, 2015 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 862.1340 |
| Device Class | Class 2 |
| Attributes | Real-World Evidence |
Real-World Evidence
| Submission | Device | Sponsor | RWD Sources | RWE Use Summary | Key Tags |
|---|---|---|---|---|---|
| K141289 · Jul 24, 2015 | TC-THUNDERBOLT AUTOMATED URINE ANALYZER SYSTEM AND TC-THUNDERBOLT URS-10 STRIPS | Teco Diagnostics | External clinical site urine samples | Clinical urine samples were used in a method comparison study to evaluate the performance of the TC-Thunderbolt Automated Urine Analyzer System against the predicate Uritek-720+ analyzer. | Method comparison; Clinical urine samples; Performance evaluation |
Clinical Evidence
| Study Design | Population | Comparator | Key Endpoints |
|---|---|---|---|
| Method Comparison Study; Method comparison study using clinical urine samples; Follow-up/Duration: Not applicable | Human urine samples; Sample Size: 487 | Uritek-720+ Urine Analyzer | Percent exact match agreement and percent agreement within 1 color block |
Indications for Use
The TC-Thunderbolt Automated Urine Analyzer System is an in vitto diagnostic device used to automate the urine chemistry analysis using TC-Thunderbolt URS-10 strips. It produces semi-quantitative results of glucose, protein, pH, bilirubin, blood, ketone, urobilinogen, nitrite, specific gravity and leukocytes in urine. TC-Thunderbolt URS-10 strips are intended for use only with TC-Thunderbolt Automated Urine Analyzer System, they are not intended for manual visual reading. This device is for clinical laboratory use only. This device is not for Point of Care Use. These measurements are used to aid in the diagnosis of metabolic disorders, kidney function anomalies, urinary tract infections and liver function.
Device Story
Automated urine chemistry analyzer; uses TC-Thunderbolt URS-10 reagent strips. Input: urine sample via automated suction needle/pipe. Operation: reflectance photometry measures color changes on reagent pads; digital analysis determines semi-quantitative results for 10 analytes. Output: printed/saved analysis report. Used in clinical laboratories by trained personnel. Benefits: automates sample application and reading, reducing manual handling compared to predicate. Healthcare providers use results to aid diagnosis of metabolic, renal, urinary, and liver conditions.
Clinical Evidence
Bench testing only. Precision/reproducibility evaluated with 3 control levels (20 replicates/level). Linearity/reportable range validated with spiked urine samples. Analytical specificity tested against 19 potential interferents; interference noted for specific analytes (e.g., ascorbic acid, hemoglobin, glucose). Method comparison study performed against predicate (n=487 clinical specimens) showing high agreement (overall exact match >95% for most analytes).
Technological Characteristics
Reflectance photometer; automated sample-suction/strip-application mechanism. Uses 10-pad plastic reagent strips (110mm x 5mm). Calibration via dedicated calibration strip. Connectivity includes barcode scanner for specimen ID. Software-controlled analysis. Operates at 25°C ± 5°C, <75% humidity.
Indications for Use
Indicated for clinical laboratory use to automate urine chemistry analysis for semi-quantitative measurement of glucose, protein, pH, bilirubin, blood, ketone, urobilinogen, nitrite, specific gravity, and leukocytes in urine to aid in diagnosis of metabolic disorders, kidney function anomalies, urinary tract infections, and liver function. Not for Point of Care use.
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
- Uritek-720+ Urine Analyzer with Teco Diagnostic URS-10 strips (k051526)
Submission Summary (Full Text)
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510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION
DECISION SUMMARY
ASSAY AND INSTRUMENT COMBINATION TEMPLATE
A. 510(k) Number:
k141289
B. Purpose for Submission:
New Device
C. Measurand:
Urinary glucose, blood, leukocyte, 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:
TC-Thunderbolt Automated Urine Analyzer System
G. Regulatory Information:
| Device / Analyte | Product Code | Device Class | Regulation |
| --- | --- | --- | --- |
| Urinary Glucose (non-quantitative) Test System | JIL | II | 21 CFR 862.1340 |
| Occult Blood Test | JIO | II | 21 CFR 864.6550 |
| Automated Urinalysis System | KQO | I | 21 CFR 862.2900 |
| Leukocytes Peroxidase Test | LJX | I | 21 CFR 864.7675 |
| Urinary pH (non-quantitative) Test System | CEN | I | 21 CFR 862.1550 |
| Nitrite (non-quantitative) Test System | JMT | I | 21 CFR 862.1510 |
| Urinary Protein or Albumin (non-quantitative) Test System | JIR | I | 21 CFR 862.1645 |
| Ketones (non-quantitative) Test System | JIN | I | 21 CFR 862.1435 |
| Urinary Urobilinogen (non-quantitative) Test System | CDM | I | 21 CFR 862.1785 |
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| Device / Analyte | Product Code | Device Class | Regulation |
| --- | --- | --- | --- |
| Urinary Bilirubin and conjugates (non-quantitative) Test System | JJB | I | 21 CFR 862.1115 |
| Refractometer for clinical use | JRE | I | 21 CFR 862.2800 |
Panel:
(75) Clinical Chemistry and (81) Hematology
H. Intended Use:
1. Intended use(s):
See Indication for use below.
2. Indication(s) for use:
The TC-Thunderbolt Automated Urine Analyzer System is an in vitro diagnostic device used to automate the urine chemistry analysis using TC-Thunderbolt URS-10 strips. It produces semi-quantitative results of glucose, protein, pH, bilirubin, blood, ketone, urobilinogen, nitrite, specific gravity, and leukocytes in urine. TC-Thunderbolt URS-10 strips are intended for use only with TC-Thunderbolt Automated Urine Analyzer System, they are not intended for manual visual reading. This device is for clinical laboratory use only. This device is not for Point of Care Use. These measurements are used to aid in the diagnosis of metabolic disorders, kidney function abnormalities, urinary tract infection, and liver function.
3. Special conditions for use statement(s):
For prescription use
4. Special instrument requirements:
TC-Thunderbolt Automated Urine Analyzer
I. Device Description:
The TC-Thunderbolt Automated Urine Analyzer System is an automated urine chemistry analyzer design for use with the TC-Thunderbolt Urine Reagent Strips. The system transfers a urine sample via a sample-suction needle and pipe, which extracts and applies the sample to the test strip; the test module then uses the principle of light-reflection to determine the changes in paper color, conduct a digital analysis on the central portion most uniform in color of the paper, and obtain results. When one specimen is finished, the device automatically cleans itself and extracts the next specimen to repeat the testing process, and if required, prints and saves the urine analysis report.
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The TC-Thunderbolt Urine Reagent Strips (URS) are firm plastic strips to which ten different reagent pads are affixed. The TC-Thunderbolt URS-10 Reagent Strips are for the semi-quantitative and qualitative detection of glucose, bilirubin, ketones, specific gravity, blood, pH, protein, urobilinogen, nitrite, and leukocytes in urine. The reagent strips are packaged along with a drying agent in a plastic bottle with a twist-off cap. Each strip is stable and ready to use upon removal from the bottle. The entire strip is disposable.
## J. Substantial Equivalence Information:
1. Predicate device name(s):
Teco Diagnostic 720+ Urine Analyzer and Teco Diagnostic URS-10 strips
2. Predicate 510(k) number(s):
k051526
3. Comparison with predicate:
| Similarities / Difference | | |
| --- | --- | --- |
| Item | Candidate Device
TC-Thunderbolt Automated
Urine Analyzer System
(k141289) | Predicate Device
Uritek-720+ Urine Analyzer
with Teco Diagnostic URS-10 strips
(k051526) |
| Intended Use | Analysis of glucose, protein, pH, bilirubin, blood, ketone, urobilinogen, nitrite, specific gravity and leukocytes in urine of glucose, protein, pH, bilirubin, blood, ketones, urobilinogen, nitrite, specific gravity, and leukocytes in urine. | Same |
| Analyzer Basic Operating Principle | Reflectance Photometer | Same |
| Analyzer Calibration method | Calibration strip | Same |
| Specimen | Urine | Same |
| Strip physical description | Plastic strips affixed with reagent pads | Same |
| Urine Application to the Analyzer | Automatic sample suction, strip advance, and sample application technology | Test strip must be dipped in urine. Dry the strip on an absorbent paper and place on the test table manually. |
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| Similarities / Difference | | |
| --- | --- | --- |
| Item | Candidate Device
TC-Thunderbolt Automated
Urine Analyzer System
(k141289) | Predicate Device
Uritek-720+ Urine Analyzer
with Teco Diagnostic URS-10 strips
(k051526) |
| Analyzer Environment requirement | Ambient temperature: 25°C+5°C; Relative humidity: <75% | Ambient temperature: 0°C to 40°C; Relative humidity: <85% |
| Strip Dimension | 110mm (length) x 5mm (width) | 108mm (length) x 5mm (width) |
K. Standard/Guidance Document Referenced (if applicable):
None Referenced.
L. Test Principle:
Glucose: This test is based on a double sequential enzyme reaction. One enzyme, glucose oxidase, catalyzes the formation of gluconic acid and hydrogen peroxide from the oxidation of glucose. A second enzyme, peroxidase, catalyzes the reaction of hydrogen peroxide with potassium iodide chromogen to oxidize the chromogen to colors ranging from blue-green to greenish-brown through brown and dark brown.
Bilirubin: This test is based on the coupling of bilirubin with a diazotized dichloroaniline in a strongly acid medium. The colors range from light tan to reddish-brown.
Ketone: This test is 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: This test is 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: This test is 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: This test is 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.
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Protein: This test is 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: This test is 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 with $p$-arsanilic acid to form 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.
Leukocytes: This test is 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:
The repeatability of the TC-Thunderbolt Automated Urine Analyzer System was evaluated using three levels of urine controls. 20 replicates of each level (negative, low positive, and high positive) were analyzed on one TC-Thunderbolt Automated Urine Analyzer with three lots of TC-Thunderbolt URS-10 strips by three operators on one day. The results are summarized below:
Control level 1:
| Analyte | Control Level 1 | Exact Block Agreement % | ±1 Color Block Agreement % |
| --- | --- | --- | --- |
| Glucose | 500 mg/dL | 58/60 (96.67%) | 60/60 (100%) |
| Bilirubin | Moderate | 60/60 (100%) | 60/60 (100%) |
| Ketone | 40 mg/dL | 60/60 (100%) | 60/60 (100%) |
| Specific Gravity | 1.015 | 60/60 (100%) | 60/60 (100%) |
| Blood | Moderate | 59/60 (98.34%) | 60/60 (100%) |
| Nitrite | Positive | 60/60 (100%) | 60/60 (100%) |
| Protein | 300 mg/dL | 60/60 (100%) | 60/60 (100%) |
| Urobilinogen | 8 EU/dL | 60/60 (100%) | 60/60 (100%) |
| Leukocytes | Moderate | 60/60 (100%) | 60/60 (100%) |
| pH | 7.5 | 60/60 (100%) | 60/60 (100%) |
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Control level 2:
| Analyte | Control Level 2 | Exact Block Agreement % | ±1 Color Block Agreement % |
| --- | --- | --- | --- |
| Glucose | 100 mg/dL | 58/60 (96.67%) | 60/60 (100%) |
| Bilirubin | Small | 60/60 (100%) | 60/60 (100%) |
| Ketone | 40 mg/dL | 59/60 (98.83%) | 60/60 (100%) |
| Specific Gravity | 1.015 | 57/60 (95%) | 60/60 (100%) |
| Blood | Trace | 59/60 (100%) | 60/60 (100%) |
| Nitrite | Positive | 60/60 (100%) | 60/60 (100%) |
| Protein | negative | 60/60 (100%) | 60/60 (100%) |
| Urobilinogen | 0.2 EU/dL | 60/60 (100%) | 60/60 (100%) |
| Leukocytes | Small | 60/60 (100%) | 60/60 (100%) |
| pH | 7.5 | 60/60 (100%) | 60/60 (100%) |
Control level 3:
| Analyte | Control Level 3 | Exact Block Agreement % | ±1 Color Block Agreement % |
| --- | --- | --- | --- |
| Glucose | Negative | 60/60 (100%) | 60/60 (100%) |
| Bilirubin | Negative | 60/60 (100%) | 60/60 (100%) |
| Ketone | Negative | 60/60 (100%) | 60/60 (100%) |
| Specific Gravity | 1.005 | 58/60 (96.67%) | 60/60 (100%) |
| Blood | Negative | 60/60 (100%) | 60/60 (100%) |
| Nitrite | Negative | 60/60 (100%) | 60/60 (100%) |
| Protein | Negative | 60/60 (100%) | 60/60 (100%) |
| Urobilinogen | 0.2EU/dL | 60/60 (100%) | 60/60 (100%) |
| Leukocytes | Negative | 60/60 (100%) | 60/60 (100%) |
| pH | 6.5 | 60/60 (100%) | 60/60 (100%) |
A run-to-run precision study was performed testing 2 replicates of each control level (negative, low positive, and high positive) for 2 non-consecutive runs per day over 5 days. The samples were analyzed on one TC-Thunderbolt Automated Urine Analyzer with three lots of TC-Thunderbolt URS-10 strips. Run 1 and Run 2 were separated by 1 hour.
The results are summarized below:
| Analyte | Control Level 1 | Exact Block Agreement % | ±1 Color Block Agreement % |
| --- | --- | --- | --- |
| Glucose | 500 mg/dL | 60/60 (100%) | 60/60 (100%) |
| Bilirubin | Moderate | 60/60 (100%) | 60/60 (100%) |
| Ketone | 40 mg/dL | 60/60 (100%) | 60/60 (100%) |
| Specific Gravity | 1.015 | 59/60 (98.83%) | 60/60 (100%) |
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| Analyte | Control Level 1 | Exact Block Agreement % | ±1 Color Block Agreement % |
| --- | --- | --- | --- |
| Blood | Moderate | 60/60 (100%) | 60/60 (100%) |
| Nitrite | Positive | 60/60 (100%) | 60/60 (100%) |
| Protein | 300 mg/dL | 60/60 (100%) | 60/60 (100%) |
| Urobilinogen | 8 EU/dL | 59/60 (98.83%) | 60/60 (100%) |
| Leukocyte | Moderate | 60/60 (100%) | 60/60 (100%) |
| pH | 7.5 | 60/60 (100%) | 60/60 (100%) |
| Analyte | Control Level 2 | Exact Block Agreement % | ±1 Color Block Agreement % |
| --- | --- | --- | --- |
| Glucose | 100 mg/dL | 60/60 (100%) | 60/60 (100%) |
| Bilirubin | Small | 60/60 (100%) | 60/60 (100%) |
| Ketone | 40 mg/dL | 60/60 (100%) | 60/60 (100%) |
| Specific Gravity | 1.015 | 56/60 (95%) | 60/60 (100%) |
| Blood | Trace | 60/60 (100%) | 60/60 (100%) |
| Nitrite | Positive | 60/60 (100%) | 60/60 (100%) |
| Protein | Negative | 60/60 (100%) | 60/60 (100%) |
| Urobilinogen | 0.2 EU/dL | 60/60 (100%) | 60/60 (100%) |
| Leukocytes | Small | 58/60 (96.67%) | 60/60 (100%) |
| pH | 7.5 | 60/60 (100%) | 60/60 (100%) |
| Analyte | Control Level 3 | Exact Block Agreement % | ±1 Color Block Agreement % |
| --- | --- | --- | --- |
| Glucose | Negative | 60/60 (100%) | 60/60 (100%) |
| Bilirubin | Negative | 60/60 (100%) | 60/60 (100%) |
| Ketone | Negative | 60/60 (100%) | 60/60 (100%) |
| Specific Gravity | 1.005 | 60/60 (100%) | 60/60 (100%) |
| Blood | Negative | 60/60 (100%) | 60/60 (100%) |
| Nitrite | Negative | 60/60 (100%) | 60/60 (100%) |
| Protein | Negative | 60/60 (100%) | 60/60 (100%) |
| Urobilinogen | 0.2 EU/dL | 60/60 (100%) | 60/60 (100%) |
| Leukocytes | Negative | 60/60 (100%) | 60/60 (100%) |
| pH | 6.5 | 60/60 (100%) | 60/60 (100%) |
b. Linearity/assay reportable range:
The study to evaluate the reportable range (percent recovery) for each analyte color block on the TC-Thunderbolt URS-10 strip was evaluated by measuring a negative
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urine and a negative urine pool spiked with known increasing and decreasing concentrations of analytes relative to each color block on the test strip. Samples were performed in replicates of 7 by three operators on three reagents strip lots for a total of 21 measurements for every sample. A pH meter was used to confirm the pH results. The specific gravity was confirmed by a clinical, handheld refractometer. A specific gravity reading of 1.000 was obtained from distilled water. The reportable range for each pad is defined as the concentration(s) at which there is a >90% exact match for that concentration with one block/result.
The percent recovery results where a >90% exact match was obtained for each analyte at each concentration block is shown in the table below:
| Analyte | TC-Thunderbolt Color Block Output Units (Reportable Range) | Conventional Units corresponding to block | Concentrations Tested resulting in >90% exact match with a block | Percent Exact Match |
| --- | --- | --- | --- | --- |
| Glucose | - | 0 mg/dL | 0 – 50 mg/dL | 100% |
| | ± | 100 mg/dL | 100 – 175 mg/dL | 100% |
| | 1+ | 250 mg/dL | 250 – 375 mg/dL | 100% |
| | 2+ | 500 mg/dL | 500 – 625 mg/dL | 100% |
| | 3+ | 1000 mg/dL | 1000 mg/dL | 100% |
| Bilirubin | - | Negative | 0.0 – 0.25 mg/dL | 100% |
| | 1+ | Small | 0.5 – 0.75mg/dL | 100% |
| | 2+ | Moderate | 1.0 – 2.0 mg/dL | 100% |
| | 3+ | Large | 3.0 mg/dL | 100% |
| Ketone | - | Negative | 0.0 – 1.25 mg/dL | 100% |
| | ± | Trace | 5.0 – 7.5 mg/dL | 100% |
| | 1+ | 15 mg/dL | 15 mg/dL | 100% |
| | 2+ | 40 mg/dL | 33.75 – 40.0 mg/dL | 100% |
| | 3+ | 80 mg/dL | 70 – 80 mg/dL | 100% |
| Blood | - | Negative | 0.0 mg/dL | 100% |
| | ± | Trace | 0.03 – 0.043 mg/dL | 100% |
| | 1+ | Small | 0.075 – 0.158mg/dL | 100% |
| | 2+ | Moderate | 0.24 – 0.495 mg/dL | 100% |
| | 3+ | Large | 0.628 – 0.75 mg/dL | 90% |
| Protein | - | Negative | 0.0 – 3.75 mg/dL | 100% |
| | ± | Trace | 15 – 18.75 mg/dL | 90% |
| | 1+ | 30 mg/dL | 30 – 47.5 mg/dL | 100% |
| | 2+ | 100 mg/dL | 82.5 – 100 mg/dL | 95% |
| | 3+ | 300 mg/dL | 250 – 300 mg/dL | 95% |
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| Analyte | TC-Thunderbolt Color Block Output Units (Reportable Range) | Conventional Units corresponding to block | Concentrations Tested resulting in >90% exact match with a block | Percent Exact Match |
| --- | --- | --- | --- | --- |
| | 4+ | 2000 mg/dL | 1575 – 2000 mg/dL | 90% |
| Nitrite | - | Negative | 0.025 – 0.075 mg/dL | 100% |
| | + | Positive | > 0.1 mg/dL | 100% |
| Leukocyte | - | Negative | 0.0 – 11.25 ca cells/μL | 95% |
| | ± | Trace | 15 – 28.75 ca cells/μL | 95% |
| | 1+ | Small | 56.25 – 83.75 ca cells/μL | 95% |
| | 2+ | Moderate | 111.25 – 312.5 ca cells/μL | 100% |
| | 3+ | Large | 500 ca cells/μL | 100% |
| Urobilinogen | 0.2 | 0.2 mg/dL | 0.2 – 0.6 mg/dL | 100% |
| | 1.0 | 1.0 mg/dL | 1.0 - 1.50 mg/dL | 90% |
| | 2.0 | 2.0 mg/dL | 2.0 – 3.0 mg/dL | 90% |
| | 4.0 | 4.0 mg/dL | 4.0 – 5.0 mg/dL | 100% |
| | 8.0 | 8.0 mg/dL | 8.0 mg/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 | 95% |
| | 8.5 | 8.5 | 8.5 | 95% |
| 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% |
c. Traceability, Stability, Expected values (controls, calibrators, or methods):
Calibration is performed using a calibration strip. This ready-to-use calibration strip provided with the TC-Thunderbolt Automated Urinalysis System to evaluate the alignment of the strip.
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Shelf-life and open-vial stability protocols and acceptance criteria were reviewed and found to be acceptable for the TC-Thunderbolt URS-10 strips. The stability studies support the following manufacturer's claim: The strips can be stored between $15^{\circ}\mathrm{C}$ - $30^{\circ}\mathrm{C}$ ( $59^{\circ}\mathrm{F} - 86^{\circ}\mathrm{F}$ ) out of direct sunlight for 28 months. The open-vial stability is for 90 days at room temperature ( $15 - 30^{\circ}\mathrm{C}$ ).
# d. Detection limit:
A study was performed to validate the cutoff concentration for each analyte on the TC-Thunderbolt URS-10 strip. Urine samples were prepared by spiking a negative urine pool with a minimum of 4 levels across the measuring range for each analyte concentration. The samples were analyzed in replicates of 7 by three operators on three reagent strip lots, for a total of 21 data points for each level. The low cut-off concentration for each color block was defined as the lowest concentration at which $\geq 55\%$ of the test results are positive for each color block.
Summary of the performance at each color block for the tested analyte concentrations:
| Analyte | Color Block | Low Cut-off Concentration | % Positive Results at the Low Cutoff Concentration |
| --- | --- | --- | --- |
| Glucose | 100 mg/dL | 75 mg/dL | 90% |
| | 250 mg/dL | 212.5 mg/dL | 85% |
| | 500 mg/dL | 437.5 mg/dL | 85% |
| | 1000 mg/dL | 875 mg/dL | 85% |
| Bilirubin | Small | 0.375mg/dL | 57% |
| | Moderate | 1 mg/dL | 100% |
| | Large | 2.5 mg/dL | 57% |
| Ketone | Trace | 3.75mg/dL | 95% |
| | 15 mg/dL | 10 mg/dL | 55% |
| | 40 mg/dL | 27.5 mg/dL | 55% |
| | 80 mg/dL | 60 mg/dL | 95% |
| Blood | Trace | 0.023 mg/dL | 61% |
| | Small | 0.064 mg/dL | 76% |
| | Moderate | 0.199 mg/dL | 90% |
| | Large | 0.628 mg/dL | 90% |
| Protein | Trace | 11.25 mg/dL | 75% |
| | 30 mg/dL | 26.25 mg/dL | 85% |
| | 100 mg/dL | 82.5 mg/dL | 95% |
| | 300 mg/dL | 200 mg/dL | 85% |
| | 2000 mg/dL | 1150 mg/dL | 70% |
| Nitrite | Positive | 0.1 mg/dL | 55% |
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| Analyte | Color Block | Low Cut-off Concentration | % Positive Results at the Low Cutoff Concentration |
| --- | --- | --- | --- |
| Leukocyte | Trace | 15 ca cells/μL | 100% |
| | Small | 56.25 ca cells/μL | 95% |
| | Moderate | 97.5 ca cells/μL | 60% |
| | Large | 406.25 ca cells/μL | 55% |
| 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 | 6.0 mg/dL | 80% |
| pH | 5.0 | 5.0 | 95% |
| | 6.0 | 6.0 | 95% |
| | 6.5 | 6.5 | 95% |
| | 7.0 | 7.0 | 95% |
| | 7.5 | 7.5 | 95% |
| | 8.0 | 8.0 | 100% |
| | 8.5 | 8.5 | 100% |
| SG | 1.005 | 1.005 | 100% |
| | 1.010 | 1.010 | 100% |
| | 1.015 | 1.015 | 100% |
| | 1.020 | 1.020 | 100% |
| | 1.025 | 1.025 | 100% |
| | 1.030 | 1.030 | 100% |
e. Analytical specificity:
Studies were performed to assess the effect of various potential interferents on the test results of the TC-Thunderbolt Automated Urine Analyzer System. Testing was performed using two urine pools with negative and positive concentrations for all analytes. The positive pool was prepared by spiking each analyte into a negative urine sample. Each urine sample was tested in 3 replicates using the TC-Thunderbolt Automated Urine Analyzer System. Possible interference was noted when a difference of one color pad in any of the three replicates for the particular test analyte compared to either the negative (specificity) or analyte-spiked positive sample (interference).
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The concentrations of the potential interfering substances that will not have influence on the tests are shown below:
| Potential Interfering Substances | Highest Concentration not affecting the test (mg/dL) |
| --- | --- |
| Ascorbic Acid | 10 mg/dL |
| Ammonia chloride | 400 (mg/dL) |
| Albumin | 300 (mg/dL) |
| Bilirubin | 4 (mg/dL) |
| Calcium Chloride | 80 (mg/dL) |
| Citric Acid | 65 (mg/dL) |
| Creatinine | 600 (mg/dL) |
| D (+) Glucose | 500(mg/dL) |
| Glycine | 900 (mg/dL) |
| Hemoglobin | 0.3 (mg/dL) |
| Potassium Chloride | 1000 (mg/dL) |
| Sodium Chloride | 2000 (mg/dL) |
| Oxalic Acid | 20 (mg/dL) |
| Sodium Nitrate | 10 (mg/dL) |
| Sodium Nitrite | 0.5 (mg/dL) |
| Sodium Phosphate | 1000 (mg/dL) |
| Urea | 3000 (mg/dL) |
| D(+) Galactose | 300 (mg/dL) |
| Tetracycline | 100 (mg/dL) |
The following table shows the substances that did interfere with one or more of the analytes tested with the TC-Thunderbolt Automated Urine Analyzer System. Results are expressed as the lowest concentration of interfering substances that exhibit 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 | Ascorbic Acid | -1 |
| Protein | Hemoglobin ≥ 50 mg/dL, D(+) Glucose ≥ 2000 mg/dL | +1, -1 |
| Bilirubin | Ascorbic Acid ≥30 mg/dL. MESNA ≥ 50 mg/dL, Sodium Nitrite ≥ 2 mg/dL, Sodium Nitrate ≥ 10 mg/dL, D(+) Glucose ≥ 2000 mg/dL | -1 |
| Urobilinogen | - | - |
| Blood | Albumin ≥ 1000 mg/dL, Ascorbic Acid ≥30 mg/dL | +1 |
| Nitrite | D(+) Glucose ≥ 2000 mg/dL | -1 |
| Leukocytes | D(+) Glucose ≥ 2000 mg/dL, Ascorbic Acid ≥30 mg/dL | -1 |
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| Analyte | Concentration of Substance at which Interference was observed | Change in Color Block Output |
| --- | --- | --- |
| Ketone | MESNA ≥ 50 mg/dL | +3 |
| pH | Acetoacetate ≥ 60 mg/dL, Oxalic Acid ≥70, Citric Acid ≥ 130 mg/dL | +1, -1, -1 |
In addition to the interference described in the table above, the sponsor states the following in the labeling regarding other potential interfering substances: The TC-Thunderbolt URS-10 Reagent strips may be affected by substances that cause abnormal urine color such as drugs containing azo dyes (e.g. Pyridium, Azo Gantrisin, Azo Gantanol), Cephalexin and Gentamicin.
f. Assay cut-off:
Not applicable.
2. Comparison studies:
a. Method comparison with predicate device:
A method comparison study was performed using a single replicate of each clinical specimen between the TC-Thunderbolt URS-10 Strips on the TC-Thunderbolt Automated Urine Analyzer System and the Teco Diagnostic's URS-10 strips on the Uritek-720+ Urine Analyzer. Clinical samples were analyzed for the first positive color block above the negative. No spiked samples were used. Clinically positive spiked samples were used when insufficient numbers of high concentration samples were not available. These spiked samples represent less than 5% of the total samples tested.
Comparison Study Summary:
| Glucose | | | | | | |
| --- | --- | --- | --- | --- | --- | --- |
| Thunderbolt Uritek 720+ | 1000 | 500 | 250 | 100 | Neg | Overall |
| 1000 | 11 | | | | | |
| 500 | | 19 | 4 | | | |
| 250 | | 3 | 22 | 1 | | |
| 100 | | | 1 | 4 | | |
| Neg | | | | | 423 | |
| Total | 11 | 22 | 26 | 5 | 423 | 487 |
| % Agreement (Exact Match) | 100.0 | 86.36 | 84.62 | 80.0 | 100.0 | 98.36 |
| % Agreement (+/- Color Block) | 100.0 | 100.0 | 100.0 | 100.0 | 100.0 | 100.0 |
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| Bilirubin | | | | | |
| --- | --- | --- | --- | --- | --- |
| Thunderbolt Uritek 720+ | 3+ | 2+ | 1+ | Neg | Overall |
| 3+ | 6 | | | | |
| 2+ | | 7 | | | |
| 1+ | | | 40 | | |
| Neg | | | 2 | 432 | |
| Total | 6 | 7 | 42 | 432 | 487 |
| % Agreement (Exact Match) | 100.0 | 100.0 | 95.24 | 100.0 | 99.59 |
| % Agreement (+/- Color Block) | 100.0 | 100.0 | 100.0 | 100.00 | 100.0 |
| Ketones | | | | | | |
| --- | --- | --- | --- | --- | --- | --- |
| Thunderbolt Uritek 720+ | 80 | 40 | 15 | TRACE | Neg | Overall |
| 80 | 6 | | | | | |
| 40 | | 10 | 3 | | | |
| 15 | | 3 | 25 | 2 | | |
| TRACE | | | 2 | 14 | 1 | |
| Neg | | | | | 421 | |
| Total | 6 | 13 | 30 | 16 | 422 | 487 |
| % Agreement (Exact Match) | 100.0 | 76.92 | 83.33 | 87.50 | 99.76 | 97.74 |
| % Agreement (+/- Color Block) | 100.0 | 100.0 | 100.0 | 100.00 | 100.00 | 100.0 |
| Specific Gravity | | | | | | | |
| --- | --- | --- | --- | --- | --- | --- | --- |
| Thunderbolt Uritek 720+ | >1.030 | 1.025 | 1.020 | 1.015 | 1.010 | <1.005 | Overall |
| >1.030 | 9 | 1 | | | | | |
| 1.025 | 3 | 118 | 12 | | | | |
| 1.020 | | 5 | 44 | 4 | | | |
| 1.015 | | | 7 | 101 | 3 | 2 | |
| 1.010 | | | | 30 | 68 | 5 | |
| <1.005 | | | | 2 | 24 | 49 | |
| Total | 12 | 124 | 63 | 137 | 95 | 56 | 487 |
| % Agreement (Exact Match) | 75.0 | 95.16 | 69.84 | 73.72 | 71.58 | 87.50 | 79.88 |
| % Agreement (+/- Color Block) | 100.0 | 100.0 | 100.0 | 98.54 | 100.00 | 96.43 | 99.18 |
{14}
| Blood | | | | | | |
| --- | --- | --- | --- | --- | --- | --- |
| Thunderbolt Uritek 720+ | 3+ | 2+ | 1+ | TRACE | Neg | Overall |
| 3+ | 13 | 3 | | | | |
| 2+ | 1 | 45 | 6 | | | |
| 1+ | | 4 | 20 | 5 | | |
| TRACE | | | | 17 | 1 | |
| Neg | | | | 2 | 370 | |
| Total | 14 | 52 | 26 | 24 | 371 | 487 |
| % Agreement (Exact Match) | 92.86 | 86.54 | 76.92 | 70.83 | 99.73 | 95.48 |
| % Agreement (+/- Color Block) | 100.0 | 100.0 | 100.0 | 100.0 | 100.0 | 100.0 |
| Protein | | | | | | |
| --- | --- | --- | --- | --- | --- | --- |
| Thunderbolt Uritek 720+ | >300 | 100 | 30 | TRACE | Neg | Overall |
| >300 | 40 | 3 | | | | |
| 100 | 3 | 32 | | | | |
| 30 | | | 17 | | | |
| TRACE | | | 3 | 20 | | |
| Neg | | | | 1 | 368 | |
| Total | 43 | 35 | 20 | 21 | 368 | 487 |
| % Agreement (Exact Match) | 93.02 | 91.43 | 85.00 | 95.24 | 100.0 | 97.95 |
| % Agreement (+/- Color Block) | 100.0 | 100.0 | 100.0 | 100.0 | 100.0 | 100.0 |
| Urobilinogen | | | | | | |
| --- | --- | --- | --- | --- | --- | --- |
| Thunderbolt Uritek 720+ | >8.0 | 4.0 | 2.0 | 1.0 | 0.2 | Overall |
| >8.0 | 10 | 1 | | | | |
| 4.0 | 1 | 66 | 4 | | | |
| 2.0 | | 1 | 27 | 1 | | |
| 1.0 | | | | 31 | 13 | |
| 0.2 | | | | 6 | 332 | |
| Total | 11 | 68 | 31 | 32 | 345 | 487 |
| % Agreement (Exact Match) | 90.91 | 97.06 | 87.10 | 96.88 | 96.23 | 95.69 |
| % Agreement (+/- Color Block) | 100.0 | 100.0 | 100.0 | 100.0 | 100.0 | 100.0 |
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| pH | | | | | | | | |
| --- | --- | --- | --- | --- | --- | --- | --- | --- |
| Thunderbolt Uritek 720+ | 8.5 | 8.0 | 7.5 | 7.0 | 6.5 | 6.0 | 5.0 | Overall |
| 8.5 | 10 | | | | | | | |
| 8.0 | | 12 | | | | | | |
| 7.5 | | | 111 | 4 | 1 | | | |
| 7.0 | | | 3 | 59 | 2 | 1 | | |
| 6.5 | | | | 3 | 94 | 33 | | |
| 6.0 | | | | | | 64 | 18 | |
| 5.0 | | | | | | 1 | 71 | |
| Total | 10 | 12 | 114 | 66 | 97 | 99 | 89 | 487 |
| % Agreement (Exact Match) | 100 | 100 | 97.37 | 89.39 | 96.91 | 64.65 | 79.78 | 86.45 |
| % Agreement (+/- Color Block) | 100 | 100 | 100.0 | 100 | 98.97 | 98.99 | 100 | 99.59 |
| Nitrite | | | |
| --- | --- | --- | --- |
| Thunderbolt Uritek 720+ | + | - | Overall |
| + | 70 | | |
| - | 1 | 416 | |
| Total | 71 | 416 | 373 |
| % Agreement (Exact Match) | 98.59 | 100 | 99.79 |
| % Agreement (+/- Color Block) | 100.0 | 100 | 100.0 |
| Leukocyte | | | | | | |
| --- | --- | --- | --- | --- | --- | --- |
| Thunderbolt Uritek 720+ | 3+ | 2+ | 1+ | TRACE | Neg | Overall |
| 3+ | 12 | | | | | |
| 2+ | 1 | 17 | 4 | | | |
| 1+ | | 5 | 27 | 5 | | |
| Trace | | | 1 | 15 | | |
| Neg | | | | | 400 | |
| Total | 13 | 22 | 32 | 20 | 400 | 487 |
| % Agreement (Exact Match) | 92.31 | 77.27 | 84.38 | 75.0 | 100.0 | 96.71 |
| % Agreement (+/- Color Block) | 100.0 | 100.0 | 96.88 | 100.0 | 100.0 | 100.0 |
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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.
5. Expected values/Reference range:
Glucose: Small amounts of glucose are normally excreted by the kidney.³ Concentrations as little as 0.1 g/dl glucose, read either at 10 or 30 seconds, may be significantly abnormal if found consistently.
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.⁴⁻⁶ In starvation diets, or in other abnormal carbohydrate metabolism situation, ketones appear in the urine in excessively large amounts before serum ketones are elevated.⁷
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 1.016-1.022.⁸ In severe renal damage, the specific gravity is fixed at 1.010, the value of the glomerular filtrate.
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: 4.5-8.0 average: 6.0.¹
{17}
Protein: In 24-hour urine, 1-14 mg/dl of protein may be excreted by the normal kidney.² 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.¹ 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. Tietz, N.W.: Clinical Guide to Laboratory Tests; W.B. Saunders Company, (1976).
2. Burtis, C.A. and Ashwood, E.R.: Tietz Textbook of Clinical Chemistry 2nd Ed. 2205; (1994).
3. Schersten, B. and Fritz, H.: Subnormal Levels of Glucose in Urine. JAMA 201:129-132; (1967).
4. McGarry, J.D.: Lilly Lecture, 1978: New Perspectives in the Regulation of Ketogenesis. Diabetes 28: 517-523 May, (1978).
5. Williamson, D.H.: Physiological ketoses, or Why Ketone Bodies? Postgrad. Med. J. (June Suppl.): 371-375: (1971).
6. Paterson, P. et al.: Maternal and Fetal Ketone Concentrations in Plasma and Urine. Lancet: 862-865; April 22, (1967).
7. 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).
8. Henry, J.B. et al.: Clinical Diagnosis and Management by Laboratory Methods, 16th Ed. Philadelphia: Saunders; (1979).
N. Instrument Name:
TC-Thunderbolt Automated Urine Analyzer
{18}
O. System Descriptions:
1. Modes of Operation:
Automatic sample-suction, strip advance, and sample application.
2. Software:
FDA has reviewed applicant’s Hazard Analysis and software development processes for this line of product types:
Yes ☐ X ☐ or No ☐
The following sections are presented in the submission and they appear adequate based on the level of concern and information provided in the Guidance for Content of Premarket Submissions for Software Contained in Medical Devices, May 11, 2005.
Level of Concern – The sponsor has classified their device as a Moderate Level of Concern.
3. Specimen Identification:
Bar-code scanner.
4. Specimen Sampling and Handling:
The TC-Thunderbolt Automated Urine Analyzer uses automatic sample-suction, strip advance, and sample-application technologies.
5. Calibration:
The TC-Thunderbolt Automated Urine Analyzer System uses a plastic calibration strip to perform a calibration reflectance check and test module alignment. The calibration strip is included with the system. There are two different kinds of calibration. One is to ensure the stability of the light source; it is performed every time the instrument is switched on. The other is to align the test module and should be performed every 4 to 6 months.
6. Quality Control:
The labeling states:
For best results, performance of TC-Thunderbolt Urine Reagent Strips should be confirmed by controls whenever a new bottle is first opened. Each laboratory should establish its own goals for adequate standards of performance, and should question handling and testing procedures if these standards are not met.
{19}
P. Other Supportive Instrument Performance Characteristics Data Not Covered In The "Performance Characteristics" Section above:
None.
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.
