(431 days)
Not Found
No
The summary describes a standard automated urine chemistry analyzer that reads test strips. There is no mention of AI, ML, or any advanced algorithms beyond basic signal processing for reading the color blocks on the strips. The performance studies focus on traditional analytical validation metrics.
No.
Explanation: This device is explicitly described as an "in vitro diagnostic device" used to automate urine chemistry analysis, which aids in the diagnosis of various conditions. It does not provide any therapeutic function.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is "an in vitro diagnostic device" and that its measurements are "used to aid in the diagnosis of metabolic disorders, kidney function anomalies, urinary tract infections and liver function."
No
The device description explicitly states the system consists of the "TC-Thunderbolt Automated Urine Analyzer and the TC-Thunderbolt URS-10 strips," indicating both hardware (the analyzer) and consumables (the strips) are part of the system, not just software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The "Intended Use / Indications for Use" section explicitly states: "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."
- Function: The device analyzes urine samples (an in vitro specimen) to provide information about a patient's health status, which is the core purpose of an IVD.
- Clinical Use: It is intended for "clinical laboratory use only" and the measurements are used "to aid in the diagnosis of metabolic disorders, kidney function anomalies, urinary tract infections and liver function," all of which are diagnostic purposes.
N/A
Intended Use / Indications 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 anomalies, urinary tract infections and liver function.
Product codes (comma separated list FDA assigned to the subject device)
JIL, JIO, KQO, LJX, JRE, CEN, JMT, JIR, JIN, CDM, JJB
Device Description
The proposed device is an automated urine chemistry analyzer system intended for use only with TC-Thunderbolt URS-10 strips for the measurement of ten urine chemistry analytes from the chemistry strip. The system consists of the TC-Thunderbolt Automated Urine Analyzer and the TC-Thunderbolt URS-10 strips.
Mentions image processing
The test module 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.
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Light reflection (color intensity)
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Clinical laboratory use only.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Precision Study:
- Within Run: Commercially available urine control solutions at Level I (High analyte concentration), Level II (Low analyte concentration) and Level III (Negative). 20 replicate assays of each level were analyzed on TC-Thunderbolt Automated Urine Analyzer with three lots of TC-Thunderbolt URS-10 strips by three operators. A total of 60 strips were used for each level control solution tested.
- Run to Run: Each control level (negative, low positive, and high positive) was tested by three operators with three lots of TC-Thunderbolt URS-10 strips in two replicate assays for 2 non-consecutive runs/day over 5 days. Run 1 and Run 2 were separated by at least 1 hour. A total of 60 strips were used for each level control solution tested.
Method Comparison Study:
- Urine samples provided by external clinical sites.
- Samples were collected within 4 hours of testing if maintained at room temperature or were stored for up to 8 hours prior to testing if maintained at 2-8°C.
- A pool of negative urine samples were spiked to elevated level with the analytes to be evaluated to obtain a desired range of abnormal values. These spiked samples represent 10% of the total samples tested.
- For each chemistry analyte, the values obtained for the individual urine samples were referred to the respective cut-off values for each system to discriminate between the negative (normal) and positive (abnormal) findings.
Sensitivity/Cutoff Point Determination Study:
- Samples were prepared by spiking the specified analyte concentration into negative urine with a minimum of 4 levels across the measuring range for each color block.
- Each pool was then analyzed in replicates of 7 by 3 operators on each of the 3 individual strip lots, for a total of 21 data points for each level.
Linearity Study/Assay Reportable Range Study:
- Negative urine and negative urine spiked with known increasing concentrations of analytes relative to each color block covering the entire measuring range of each analyte present on the TC-Thunderbolt URS-10 strip.
- Sample measurement was performed in replicates of 7 by 3 operators on each of 3 individual strip lots, for a total of 21 measurements for every sample tested.
- Specific gravity measurements were performed in replicates of 7 by 3 operators on each of 3 individual strip lots, for a total of 21 measurements for every sample tested.
Analytical Specificity and Interference Study:
- Urine sample pools were prepared at 2 concentrations for each urine chemistry analyte: negative and positive.
- The negative sample pools had no analyte present while the positive sample pools were prepared by spiking each analyte into negative urine at specified concentrations.
- Each urine sample was tested with 3 replicates using TC-Thunderbolt Urine Analyzer System and a mean result was calculated.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Precision Study Summary:
- Within Run:
- Glucose (500 mg/dL): 96.67% Exact Match, 100% +/- Color Block (N=60)
- Bilirubin (Moderate): 100% Exact Match, 100% +/- Color Block (N=60)
- Ketone (40 mg/dL): 100% Exact Match, 100% +/- Color Block (N=60)
- Specific Gravity (1.015): 100% Exact Match, 100% +/- Color Block (N=60)
- Blood (Moderate): 98.34% Exact Match, 100% +/- Color Block (N=60)
- Nitrite (Positive): 100% Exact Match, 100% +/- Color Block (N=60)
- Protein (300 mg/dL): 100% Exact Match, 100% +/- Color Block (N=60)
- Urobilinogen (8 EU/dL): 100% Exact Match, 100% +/- Color Block (N=60)
- Leukocyte (Moderate): 100% Exact Match, 100% +/- Color Block (N=60)
- pH (7.5): 100% Exact Match, 100% +/- Color Block (N=60)
- Glucose (100 mg/dL): 96.67% Exact Match, 100% +/- Color Block (N=60)
- Bilirubin (Small): 100% Exact Match, 100% +/- Color Block (N=60)
- Ketone (40 mg/dL): 98.83% Exact Match, 100% +/- Color Block (N=60)
- Specific Gravity (1.015): 95% Exact Match, 100% +/- Color Block (N=60)
- Blood (Trace): 100% Exact Match, 100% +/- Color Block (N=60)
- Nitrite (Positive): 100% Exact Match, 100% +/- Color Block (N=60)
- Protein (Negative): 100% Exact Match, 100% +/- Color Block (N=60)
- Urobilinogen (0.2 EU/dL): 100% Exact Match, 100% +/- Color Block (N=60)
- Leukocyte (Small): 100% Exact Match, 100% +/- Color Block (N=60)
- pH (7.5): 100% Exact Match, 100% +/- Color Block (N=60)
- Glucose (Negative): 100% Exact Match, 100% +/- Color Block (N=60)
- Bilirubin (Negative): 100% Exact Match, 100% +/- Color Block (N=60)
- Ketone (Negative): 100% Exact Match, 100% +/- Color Block (N=60)
- Specific Gravity (1.005): 96.67% Exact Match, 100% +/- Color Block (N=60)
- Blood (Negative): 100% Exact Match, 100% +/- Color Block (N=60)
- Nitrite (Negative): 100% Exact Match, 100% +/- Color Block (N=60)
- Protein (Negative): 100% Exact Match, 100% +/- Color Block (N=60)
- Urobilinogen (0.2 EU/dL): 100% Exact Match, 100% +/- Color Block (N=60)
- Leukocyte (Negative): 100% Exact Match, 100% +/- Color Block (N=60)
- pH (6.5): 96.67% Exact Match, 100% +/- Color Block (N=60)
- Run to Run:
- Glucose (500 mg/dL): 100% Exact Match, 100% +/- Color Block (N=60)
- Bilirubin (Moderate): 100% Exact Match, 100% +/- Color Block (N=60)
- Ketone (40 mg/dL): 100% Exact Match, 100% +/- Color Block (N=60)
- Specific Gravity (1.015): 98.83% Exact Match, 100% +/- Color Block (N=60)
- Blood (Moderate): 100% Exact Match, 100% +/- Color Block (N=60)
- Nitrite (Positive): 100% Exact Match, 100% +/- Color Block (N=60)
- Protein (300 mg/dL): 100% Exact Match, 100% +/- Color Block (N=60)
- Urobilinogen (8 EU/dL): 98.83% Exact Match, 100% +/- Color Block (N=60)
- Leukocyte (Moderate): 100% Exact Match, 100% +/- Color Block (N=60)
- pH (7.5): 100% Exact Match, 100% +/- Color Block (N=60)
- Glucose (100 mg/dL): 100% Exact Match, 100% +/- Color Block (N=60)
- Bilirubin (Small): 100% Exact Match, 100% +/- Color Block (N=60)
- Ketone (40 mg/dL): 100% Exact Match, 100% +/- Color Block (N=60)
- Specific Gravity (1.015): 93.34% Exact Match, 100% +/- Color Block (N=60)
- Blood (Trace): 100% Exact Match, 100% +/- Color Block (N=60)
- Nitrite (Positive): 100% Exact Match, 100% +/- Color Block (N=60)
- Protein (Negative): 100% Exact Match, 100% +/- Color Block (N=60)
- Urobilinogen (0.2 EU/dL): 100% Exact Match, 100% +/- Color Block (N=60)
- Leukocyte (Small): 96.67% Exact Match, 100% +/- Color Block (N=60)
- pH (7.5): 100% Exact Match, 100% +/- Color Block (N=60)
- Glucose (Negative): 100% Exact Match, 100% +/- Color Block (N=60)
- Bilirubin (Negative): 100% Exact Match, 100% +/- Color Block (N=60)
- Ketone (Negative): 100% Exact Match, 100% +/- Color Block (N=60)
- Specific Gravity (1.005): 100% Exact Match, 100% +/- Color Block (N=60)
- Blood (Negative): 100% Exact Match, 100% +/- Color Block (N=60)
- Nitrite (Negative): 100% Exact Match, 100% +/- Color Block (N=60)
- Protein (Negative): 100% Exact Match, 100% +/- Color Block (N=60)
- Urobilinogen (0.2 EU/dL): 100% Exact Match, 100% +/- Color Block (N=60)
- Leukocyte (Negative): 100% Exact Match, 100% +/- Color Block (N=60)
- pH (6.5): 100% Exact Match, 100% +/- Color Block (N=60)
Method Comparison Study Summary (N=487 for most analytes, specific N varies slightly by analyte and color block):
- Glucose: 98.36% overall exact match, 100% overall agreement +/- one color block.
- Bilirubin: 99.59% overall exact match, 100% overall agreement +/- one color block.
- Ketone: 97.74% overall exact match, 100% overall agreement +/- one color block.
- Specific Gravity: 79.88% overall exact match, 99.18% overall agreement +/- one color block. Acceptance Criteria for SG is +/- 0.005.
- Blood: 95.48% overall exact match, 100% overall agreement +/- one color block.
- Protein: 97.95% overall exact match, 100% overall agreement +/- one color block.
- Urobilinogen: 95.69% overall exact match, 100% overall agreement +/- one color block.
- pH: 86.45% overall exact match, 99.59% overall agreement +/- one color block.
- Nitrite: 99.79% overall exact match, 100% overall agreement +/- one color block.
- Leukocyte: 96.71% overall exact match, 100% overall agreement +/- one color block.
Sensitivity/Cutoff Point Determination Study Summary:
- Cutoff point is defined as the lowest concentration at which >55% of test results are positive.
- Specific cutoff concentrations and % positive results are provided for each analyte and color block (e.g., Glucose 100 mg/dL cutoff at 75 mg/dL with 90% positive results; Bilirubin Small cutoff at 0.375 mg/dL with 57% positive results).
Linearity Study/Assay Reportable Range Study Summary:
- The study identified the measuring range for each color block for all analytes (e.g., Glucose Negative: 0.0 - 75 mg/dL, 100 mg/dL: 75 - 212.5 mg/dL, etc.).
Analytical Specificity and Interference Study Summary:
- Lists potential interfering substances and the highest concentration at which they caused no interference (e.g., Ascorbic Acid 10 mg/dL, Albumin 300 mg/dL).
- Lists substances that caused interference, the concentration at which interference was observed, and the resulting change in color block output (e.g., Glucose with Ascorbic Acid ≥ 30 mg/dL caused -1 change).
Shelf Life Studies:
- Accelerated Stability Study: Three lots passed Quality Control testing for 91 days at 37°C ± 2°C. Expected shelf life is 28 months based on these results.
- Real-time Stability Study: On-going study. Three lots passed 12 months Quality Control testing. Plan to continue testing until 28 months.
- Open-vial Stability Study: Three lots passed Quality Control testing for 91 days at 15-30°C. Expected shelf life of Open Vial strips is 90 days.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
- Percent Agreement (Exact Match) from Method Comparison.
- Percent Agreement (+/- Color Block) from Method Comparison.
- Percent Agreement (Exact Match) and Percent Agreement (+/- Color Block) from Precision studies (Within Run and Run to Run).
- % Positive Results at various cutoff concentrations from Sensitivity/Cutoff Point Determination.
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 862.1340 Urinary glucose (nonquantitative) test system.
(a)
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.(b)
Classification. Class II.
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, arranged in a way that they appear to be connected or overlapping.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
July 24, 2015
TECO DIAGNOSTICS AQUIL MERCHANT RESEARCH SCIENTIST 1268 NORTH LAKEVIEW AVE. ANAHEIM CA 92807
Re: K141289
Trade/Device Name: TC-Thunderbolt Automated Urine Analyzer System Regulation Number: 21 CFR 862.1340 Regulation Name: Urinary glucose (nonquantitative) test system Regulatory Class: II Product Code: JIL, JIO, KQO, LJX, JRE, CEN, JMT, JIR, JIN, CDM, JJB Dated: July 17, 2015 Received: July 20, 2015
Dear Mr. Merchant:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug. and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21. Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
1
If you desire specific advice for your device on our labeling regulations (21 CFR Parts 801 and 809), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours.
Courtney
Courtney H. Lias, Ph.D. Director Division of Chemistry and Toxicology Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
2
| | 2301VЯЭг ИАМИН ОИА НТТАЭН ЭО ТИЭМТЯАЯЭД
ndications for Use
FoireinimbA ഉഗ്വേര Aministration | Expiration Detel: James, 31, 2017
Form Approved: OMB No. 0810-0120
See PRA Statesment below |
|--------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------|
| 141289
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| TC-Thunderbolt Automated Urine Analyzer System
Device Name | | |
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liver function |
| | | |
| | | |
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| 88 1885 888 8886 (88 | ้างอิง
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3
510(k) Summary
Applicant:
510(k) Number: K141289 Teco Diagnostics 1268 N. Lakeview Avenue Anaheim, CA 92807
Aquil Merchant, M.S., Research Scientist Tel: 714.463.1111 | Fax: 714.463.1169 Email: amerchant@tecodiag.com | Web: http://www.tecodiag.com Date: 07/24/2015
4.1) TC-Thunderbolt Automated Urine Analyzer System:
A) Proprietary and Established Names:
Proprietary Names: TC-Thunderbolt Automated Urine Analyzer System
Common Names: Automated Urine Analyzer, Urine Test System (non-quantitative). The system consists of the TC-Thunderbolt Automated Urine Analyzer and the TC-Thunderbolt URS-10 strips.
| Regulation section | Code | Test | Classification |
|---|---|---|---|
| 21 CFR § 862.1340 | JIL | Urinary Glucose (nonquantitative) Test System | II |
| 21 CFR § 864.6550 | JIO | Occult Blood Test | II |
| 21 CFR § 862.2900 | KQO | Automated Urinalysis System | I |
| 21 CFR § 864.7675 | LJX | Leukocyte Peroxidase Test | I |
| 21 CFR § 862.2800 | JRE | Refractometer for clinical use | I |
| 21 CFR § 862.1550 | CEN | Urinary pH (nonquantitative) Test System | I |
| 21 CFR § 862.1510 | JMT | Nitrite (nonquantitative) Test System | I |
| 21 CFR § 862.1645 | JIR | Urinary Protein or Albumin (nonquantitative) Test | |
| System | I | ||
| 21 CFR § 862.1435 | JIN | Ketones (nonquantitative) Test System | I |
| 21 CFR § 862.1785 | CDM | Urinary Urobilinogen (nonquantitative) Test System | I |
| 21 CFR § 862.1115 | JJB | Urinary Bilirubin and its conjugates (nonquantitative) Test System | I |
4.2) Regulatory Information:
4.3) Indication 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.
4
4.4) Predicate Device:
Uritek-720+ Urine Analyzer for the use with Teco Diagnostic's URS-10 strips (K051526).
4.5) Description of the proposed device:
The proposed device is an automated urine chemistry analyzer system intended for use only with TC-Thunderbolt URS-10 strips for the measurement of ten urine chemistry analytes from the chemistry strip. The system consists of the TC-Thunderbolt Automated Urine Analyzer and the TC-Thunderbolt URS-10 strips.
| Description | Proposed | Predicate |
|---|---|---|
| Device | TC-Thunderbolt Automated | |
| Analyzer System | Uritek-720+ Analyzer | |
| Intended Use | Automated Urine Chemistry Analyzer used | |
| for in vitro measurement of glucose, | ||
| protein, pH, bilirubin, blood, ketone, | ||
| urobilinogen, nitrite, specific gravity and | ||
| leukocytes in urine. | Same | |
| Design | Same as predicate | Uses proven chemical test |
| method protocol for the intended | ||
| use determinations of all 10 | ||
| parameters | ||
| Design | Same as predicate | Uses the principle of light |
| reflection to determine the color | ||
| intensity on reagent strip test | ||
| area | ||
| Design | Same as predicate | Uses testing technology of a |
| cold light source, integrating | ||
| sphere and modularized | ||
| blocking systematical design | ||
| which enhances the stability of | ||
| the optical system | ||
| Design | The test module 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 | Measures the color intensity by | |
| irradiating the white light and | ||
| detecting the reflectance on the | ||
| urine pad with an integrated | ||
| sphere photo-detector |
4.6) TC-Thunderbolt Automated Urine Analyzer System v/s Uritek-720+ Analyzer:
5
| Testing Pattern | The test module uses automatic sample-
suction, strip advance, and sample-
application technologies instead of manual
operations to facilitate urinalysis. Transfer
of urine sample takes place via a sample-
suction needle and pipe which extracts and
applies the sample to the test strip | The test strip needs to be dipped
in the test tube containing urine
sample manually. Dry the strip
on an absorbent piece of paper
and place it on the test table. |
|----------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Safety | The device has been certified to comply
with the latest applicable safety standards
which includes EN 61010-1:2010 for LVD
and EN 61010-2-101: 2002 for IVD | The device has been certified to
comply with the latest applicable
safety standards which includes
EN 61010-1:2010 for LVD and
EN 61010-2-101: 2002 for IVD |
| Electromagnetic
Compatibility | The proposed device has been tested and
certified to EN 61326-1:2006 EMC
requirements-general, EN 61326-2-6:2006
EMC requirements-particular requirements
for IVD medical equipment, EN 61000-3-
2:2006 + A1:2009 + A2: 2009 and EN
61000-3-3:2008 | The device has been tested and
certified to EN 61000-4-2, EN
61000-4-4, EN 61000-4-5 and
EN 61000-4-11 |
| Chemistry Strips | The TC-Thunderbolt Automated Urine
Analyzer System is intended for use only
with TC-Thunderbolt URS-10 strips | The Uritek-720+ analyzer is
intended for use only with Teco
Diagnostic's URS 10 strips |
| Description | TC-Thunderbolt Automated Urine Analyzer System | Teco Diagnostic's URS-10 Strips |
| Intended Specimen | Urine | Same |
| Materials Provided | Plastic strips affixed with reagent pads | Same |
| Dimension | 110mm (length) x 5mm (width) | 108mm (length) x 5mm (width) |
| Glucose Methodology | 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. | Same |
| Bilirubin Methodology | Based on the coupling of bilirubin with a diazotized dichioroaniline in a strongly acid medium. Varying bilirubin levels will produce light tan to reddish brown color proportional to its concentration in urine. | Same |
| Ketone Methodology | 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. | Same |
| Specific Gravity Methodology | 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. | Same |
| Blood Methodology | 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. | Same |
| pH Methodology | 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 | Same |
| Protein
Methodology | 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. | Same |
| Urobilinogen
Methodology | 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. | Same |
| Nitrite
Methodology | 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 from a diazonium compound in an acid
medium. The diazoniumn compound in turn
couples with 1, 2, 3, 4- tetrahydrobenzo (h)
quinolin to produce a pink color. | Same |
| Leukocyte
Methodology | 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 diazoniumn salt to produce
a beige-pink to purple color. | Same |
The TC-Thunderbolt Automated Urine Analyzer System and Uritek-720+ analyzer share the same technological characteristics including the testing parameters, print out, calibration method, and power requirements. The most notable difference is in their respective testing patterns, wherein TC-Thunderbolt Automated Urine Analyzer System uses automatic sample-suction, strip advance, and sample-application technologies and for the predicate the test strip needs to be dipped in urine sample and placed on the test table manually. In addition to this, they also differ in their display, user interface, entered parameter (user ID), dimensions and weight. These differences do not have any effect on the results of the devices since the color development and reflectance values are measured after one minute.
6
4.7) TC-Thunderbolt Automated Urine Analyzer System v/s Teco Diagnostic's URS-10 Strips:
7
The TC-Thunderbolt URS-10 Strips and Teco Diagnostic's URS-10 strips share the same characteristics including Glucose, Bilirubin, Ketone, Specific Gravity, Blood, pH, Protein, Urobilinogen, Nitrite and Leukocyte methodologies. The differences between the TC-Thunderbolt URS-10 Strips and Teco Diagnostic's URS-10 strips could be the length of the strip, paper of reagent pad and black plastic pad. The TC-Thunderbolt URS-10 strips are 2mm longer in length and have a black plastic pad at the end which is meant only for alignment purpose in the TC-Thunderbolt Automated Urine Analyzer System. However these differences do not have any effect on the results or operations of the devices.
4.8) Test Principle:
Glucose: This test is 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 greenishbrown through brown and dark brown.
Bilirubin: This test is based on the coupling of bilirubin with a diazotized dichioroaniline in a strongly acid medium. Varying bilirubin levels will produce light tan to reddish brown color proportional to its concentration in urine.
Ketone: This test is based on t reaction of acetoacetic acid with sodium n basic medium. The colors range from beige or buff-pink color for a "Negative" reading to pinkpurple for a "Positive" reading.
Specific Gravity: This test is based on the apparent pKa change of certai relation to the ionic concentration. In the presence of an indicator, the colors range from dark blue or
8
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 to yellow and yellow-green to blue-green.
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 from a diazonium compound in an acid medium. The diazoniumn 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 diazoniumn salt to produce a beige-pink to purple color.
4.9) Analytical Performance Studies
A) Precision Study Summary:
-
Within Run:
Repeatability (within run and day-to-day) precision of the TC-Thunderbolt Automated Urine Analyzer System was evaluated using commercially available urine control solutions at Level I (High analyte concentration), Level II (Low analyte concentration) and Level III (Negative). The package insert and certificate of analysis of these control solutions confirmed the specific target analyte concentration in each level. 20 replicate assays of each level (negative, and high positive) were analyzed on TC-Thunderbolt Automated Urine Analyzer with three lots of TC-Thunderbolt URS-10 strips by three operators. A total of 60 strips were used for each level control solution tested (20 strips x 1 day x 3 operators/strip lots = 60 tests per control). The results from the Within Run Precision study are summarized below:
| Analyte | Level | Exact
Match
Agreement | % Agreement
(Exact Match) | +/- Color
Block
Agreement | % Agreement
(+/- Color
Block) | N |
|-----------|-----------|-----------------------------|------------------------------|---------------------------------|-------------------------------------|----|
| Glucose | 500 mg/dL | 58/60 | 96.67 | 60/60 | 100 | 60 |
| Bilirubin | Moderate | 60/60 | 100 | 60/60 | 100 | 60 |
| Ketone | 40 mg/dL | 60/60 | 100 | 60/60 | 100 | 60 |
Urine Control Level I
9
| Specific Gravity | 1.015 | 60/60 | 100 | 60/60 | 100 | 60 |
|---|---|---|---|---|---|---|
| Blood | Moderate | 59/60 | 98.34 | 60/60 | 100 | 60 |
| Nitrite | Positive | 60/60 | 100 | 60/60 | 100 | 60 |
| Protein | 300 mg/dL | 60/60 | 100 | 60/60 | 100 | 60 |
| Urobilinogen | 8 EU/dL | 60/60 | 100 | 60/60 | 100 | 60 |
| Leukocyte | Moderate | 60/60 | 100 | 60/60 | 100 | 60 |
| pH | 7.5 | 60/60 | 100 | 60/60 | 100 | 60 |
Urine Control Level II
| Analyte | Level | Exact
Match
Agreement | %Agreement
(Exact Match) | +/- Color
Block
Agreement | %Agreement
(+/- Color
Block) | N |
|------------------|-----------|-----------------------------|-----------------------------|---------------------------------|------------------------------------|----|
| Glucose | 100 mg/dL | 58/60 | 96.67 | 60/60 | 100 | 60 |
| Bilirubin | Small | 60/60 | 100 | 60/60 | 100 | 60 |
| Ketone | 40 mg/dL | 59/60 | 98.83 | 60/60 | 100 | 60 |
| Specific Gravity | 1.015 | 57/60 | 95 | 60/60 | 100 | 60 |
| Blood | Trace | 59/60 | 100 | 60/60 | 100 | 60 |
| Nitrite | Positive | 60/60 | 100 | 60/60 | 100 | 60 |
| Protein | Negative | 60/60 | 100 | 60/60 | 100 | 60 |
| Urobilinogen | 0.2 EU/dL | 60/60 | 100 | 60/60 | 100 | 60 |
| Leukocyte | Small | 60/60 | 100 | 60/60 | 100 | 60 |
| pH | 7.5 | 60/60 | 100 | 60/60 | 100 | 60 |
Urine Control Level III
| Analyte | Level | Exact
Match
Agreement | % Agreement
(Exact Match) | +/- Color
Block
Agreement | % Agreement
(+/- Color
Block) | N |
|------------------|-----------|-----------------------------|------------------------------|---------------------------------|-------------------------------------|----|
| Glucose | Negative | 60/60 | 100 | 60/60 | 100 | 60 |
| Bilirubin | Negative | 60/60 | 100 | 60/60 | 100 | 60 |
| Ketone | Negative | 59/60 | 100 | 60/60 | 100 | 60 |
| Specific Gravity | 1.005 | 58/60 | 96.67 | 60/60 | 100 | 60 |
| Blood | Negative | 59/60 | 100 | 60/60 | 100 | 60 |
| Nitrite | Negative | 60/60 | 100 | 60/60 | 100 | 60 |
| Protein | Negative | 60/60 | 100 | 60/60 | 100 | 60 |
| Urobilinogen | 0.2 EU/dL | 60/60 | 100 | 60/60 | 100 | 60 |
| Leukocyte | Negative | 60/60 | 100 | 60/60 | 100 | 60 |
| pH | 6.5 | 58/60 | 96.67 | 60/60 | 100 | 60 |
10
> Run to Run:
TC-Thunderbolt Automated Urine Analyzer was evaluated by testing each control level (negative, low positive, and high positive) by three operators with three lots of TC-Thunderbolt URS-10 strips in two replicate assays for 2 non- consecutive runs/day over 5 days. Run 1 and Run 2 were separated by atleast 1 hour. A total of 60 strips were used for each level control solution tested (2 strips x 2 run x 5 days x 3 operators/ strip lots = 60 tests per control). The results from the Run to Run Precision study are summarized below:
Urine Control Level I
| Analyte | Level | Exact
Match
Agreement | % Agreement
(Exact Match) | +/- Color
Block
Agreement | %
Agreement
(+/- Color
Block) | N |
|------------------|-----------|-----------------------------|------------------------------|---------------------------------|----------------------------------------|----|
| Glucose | 500 mg/dL | 60/60 | 100 | 60/60 | 100 | 60 |
| Bilirubin | Moderate | 60/60 | 100 | 60/60 | 100 | 60 |
| Ketone | 40 mg/dL | 60/60 | 100 | 60/60 | 100 | 60 |
| Specific Gravity | 1.015 | 59/60 | 98.83 | 60/60 | 100 | 60 |
| Blood | Moderate | 59/60 | 100 | 60/60 | 100 | 60 |
| Nitrite | Positive | 60/60 | 100 | 60/60 | 100 | 60 |
| Protein | 300 mg/dL | 60/60 | 100 | 60/60 | 100 | 60 |
| Urobilinogen | 8 EU/dL | 59/60 | 98.83 | 60/60 | 100 | 60 |
| Leukocyte | Moderate | 60/60 | 100 | 60/60 | 100 | 60 |
| pH | 7.5 | 60/60 | 100 | 60/60 | 100 | 60 |
Urine Control Level II
| Analyte | Level | Exact
Match
Agreement | % Agreement
(Exact Match) | +/- Color
Block
Agreement | % Agreement
(+/- Color
Block) | N |
|------------------|-----------|-----------------------------|------------------------------|---------------------------------|-------------------------------------|----|
| Glucose | 100 mg/dL | 60/60 | 100 | 60/60 | 100 | 60 |
| Bilirubin | Small | 60/60 | 100 | 60/60 | 100 | 60 |
| Ketone | 40 mg/dL | 60/60 | 100 | 60/60 | 100 | 60 |
| Specific Gravity | 1.015 | 56/60 | 93.34 | 60/60 | 100 | 60 |
| Blood | Trace | 59/60 | 100 | 60/60 | 100 | 60 |
| Nitrite | Positive | 60/60 | 100 | 60/60 | 100 | 60 |
| Protein | Negative | 60/60 | 100 | 60/60 | 100 | 60 |
| Urobilinogen | 0.2 EU/dL | 60/60 | 100 | 60/60 | 100 | 60 |
| Leukocyte | Small | 58/60 | 96.67 | 60/60 | 100 | 60 |
| pH | 7.5 | 60/60 | 100 | 60/60 | 100 | 60 |
11
Urine Control Level III
| Analyte | Level | Exact
Match
Agreement | % Agreement
(Exact Match) | +/- Color
Block
Agreement | % Agreement
(+/- Color
Block) | N |
|------------------|-----------|-----------------------------|------------------------------|---------------------------------|-------------------------------------|----|
| Glucose | Negative | 60/60 | 100 | 60/60 | 100 | 60 |
| Bilirubin | Negative | 60/60 | 100 | 60/60 | 100 | 60 |
| Ketone | Negative | 60/60 | 100 | 60/60 | 100 | 60 |
| Specific Gravity | 1.005 | 60/60 | 100 | 60/60 | 100 | 60 |
| Blood | Negative | 60/60 | 100 | 60/60 | 100 | 60 |
| Nitrite | Negative | 60/60 | 100 | 60/60 | 100 | 60 |
| Protein | Negative | 60/60 | 100 | 60/60 | 100 | 60 |
| Urobilinogen | 0.2 EU/dL | 60/60 | 100 | 60/60 | 100 | 60 |
| Leukocyte | Negative | 60/60 | 100 | 60/60 | 100 | 60 |
| pH | 6.5 | 60/60 | 100 | 60/60 | 100 | 60 |
B) Method Comparison Study Summary:
This comparison study testing was performed at Teco Diagnostics, Anaheim CA in United States. The urine samples for analysis in these method comparison studies were provided by external clinical sites. Samples were collected within 4 hours of testing if maintained at room temperature or were stored for up to 8 hours prior to testing if maintained at 2-8°C. In order to obtain a desired range of abnormal values a pool of negative urine samples were spiked to elevated level with the analytes to be evaluated. These spiked samples represent 10% of the total samples tested. For each chemistry analyte, the values obtained for the individual urine samples were referred to the respective cut-off values for each system to discriminate between the negative (normal) and positive (abnormal) findings, if applicable. The data was represented in concordance charts showing percent exact match agreement and percent agreement within 1 color block.
| Glucose | ||||||
|---|---|---|---|---|---|---|
| Thunderbolt | ||||||
| Uritek-720+ | 1000 | 500 | 250 | 100 | Neg | Overall |
| 1000 | 11 | |||||
| 500 | 19 | 4 | ||||
| 250 | 3 | 22 | 1 | |||
| 100 | 4 | |||||
| Neg | 423 | |||||
| Total | 11 | 22 | 26 | 5 | 423 | 487 |
| % Agreement (Exact Match) | 100.00 | 86.36 | 84.62 | 80.00 | 100.00 | 98.36 |
| % Agreement (+/- Color Block) | 100.00 | 100.00 | 100.00 | 100.00 | 100.00 | 100.00 |
Glucose concentration levels compared at a 98.36% overall exact match and a 100% overall agreement +/- one color block match between the TC-Thunderbolt Automated Urine Analyzer System and Uritek-720+ Analyzer.
12
| Bilirubin | Uritek-720+ | 3+ | 2+ | 1+ | Neg | Overall |
|---|---|---|---|---|---|---|
| Thunderbolt | ||||||
| 3+ | 6 | |||||
| 2+ | 7 | |||||
| 1+ | 40 | |||||
| Neg | 2 | 432 | ||||
| Total | 6 | 7 | 42 | 432 | 487 | |
| % Agreement (Exact Match) | 100.00 | 100.00 | 95.24 | 100.00 | 99.59 | |
| % Agreement (+/- Color Block) | 100.00 | 100.00 | 100.00 | 100.00 | 100.00 |
Bilirubin concentration levels compared at a 99.59% overall exact match and a 100% overall agreement +/- one color block match between the TC-Thunderbolt Automated Urine Analyzer System and Uritek-720+ Analyzer.
| Ketone | |||||||
|---|---|---|---|---|---|---|---|
| Uritek-720+ | 80 | 40 | 15 | TRA | Neg | Overall | |
| Thunderbolt | 80 | 6 | |||||
| 40 | 10 | 3 | |||||
| 15 | 3 | 25 | 2 | ||||
| TRA | 2 | 14 | 1 | ||||
| Neg | 421 | ||||||
| Total | 6 | 13 | 30 | 16 | 422 | 487 | |
| % Agreement (Exact Match) | 100.00 | 76.92 | 83.33 | 87.50 | 99.76 | 97.74 | |
| % Agreement (+/- Color Block) | 100.00 | 100.00 | 100.00 | 100.00 | 100.00 | 100.00 |
Ketone concentration levels compared at a 97.74% overall exact match and a 100% overall agreement +/one color block match between the TC-Thunderbolt Automated Urine Analyzer System and Uritek-720+ Analyzer.
| Specific Gravity | |||||||
|---|---|---|---|---|---|---|---|
| Uritek-720+ | |||||||
| Thunderbolt | >1.030 | 1.025 | 1.020 | 1.015 | 1.010 | 1.030 | 9 |
| 1.025 | 3 | 118 | 12 | ||||
| 1.020 | 5 | 44 | 4 | ||||
| 1.015 | 7 | 101 | 3 | 2 | |||
| 1.010 | 30 | 68 | 5 | ||||
| 300 | 100 | 30 | TRA | Neg | Overall | ||
| >300 | 40 | 3 | |||||
| 100 | 3 | 32 | |||||
| 30 | 17 | ||||||
| TRA | 3 | 20 | |||||
| Neg | 1 | 368 | |||||
| Total | 43 | 35 | 20 | 21 | 368 | 487 | |
| % Agreement (Exact Match) | 93.02 | 91.43 | 85.00 | 95.24 | 100.00 | 97.95 | |
| % Agreement (+/- Color Block) | 100.00 | 100.00 | 100.00 | 100.00 | 100.00 | 100.00 |
Protein concentration levels compared at a 97.95% overall exact match and a 100% overall agreement +/one color block match between the TC-Thunderbolt Automated Urine Analyzer System and Uritek-720+ Analyzer.
| Urobilinogen | ||||||
|---|---|---|---|---|---|---|
| Thunderbolt | ||||||
| Uritek-720+ | >8.0 | 4 | 2 | 1 | 0.2 | Overall |
| >8.0 | 10 | 1 | ||||
| 4.0 | 1 | 66 | 4 | |||
| 2.0 | 1 | 27 | 1 | |||
| 1.0 | 31 | 13 | ||||
| 0.2 | 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) | 100.00 | 100.00 | 100.00 | 100.00 | 100.00 | 100.00 |
Urobilinogen concentration levels compared at a 95.69% overall exact match and a 100% overall agreement +/- one color block match between the TC-Thunderbolt Automated Urine Analyzer System and Uritek-720+ Analyzer.
14
| pH | ||||||||
|---|---|---|---|---|---|---|---|---|
| Thunderbolt | ||||||||
| Uritek-720+ | 8.5 | 8 | 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 | 100.00 | 100.00 | 98.97 | 98.99 | 100.00 | 99.59 |
pH concentration levels compared at an 86.45% overall exact match and a 99.59% overall agreement +/one color block match between the TC-Thunderbolt Automated Urine Analyzer System and Uritek-720+ Analyzer.
| Nitrite | Uritek-720+ | + | - | Overall |
|---|---|---|---|---|
| Thunderbolt | + | 70 | ||
| - | 1 | 416 | ||
| Total | 71 | 416 | 373 | |
| % Agreement (Exact Match) | 98.59 | 100.00 | 99.79 | |
| % Agreement (+/- Color Block) | 100.00 | 100.00 | 100.00 |
Nitrite concentration levels compared at a 99.79% overall exact match and a 100% overall agreement +/one color block match between the TC-Thunderbolt Automated Urine Analyzer System and Uritek-720+ Analyzer.
| Leukocyte | ||||||
|---|---|---|---|---|---|---|
| Thunderbolt | ||||||
| Uritek-720+ | 3+ | 2+ | 1+ | TRA | Neg | Overall |
| 3+ | 12 | |||||
| 2+ | 1 | 17 | 4 | |||
| 1+ | 5 | 27 | 5 | |||
| TRA | 1 | 15 | ||||
| Neg | 400 | |||||
| Total | 13 | 22 | 32 | 20 | 400 | 487 |
| % Agreement (Exact Match) | 92.31 | 77.27 | 84.38 | 75.00 | 100.00 | 96.71 |
| % Agreement (+/- Color Block) | 100.00 | 100.00 | 96.88 | 100.00 | 100.00 | 100.00 |
Leukocyte concentration levels compared at a 96.71% overall exact match and a 100% overall agreement +/- one color block match between the TC-Thunderbolt Automated Urine Analyzer System and Uritek-720+ Analyzer.
15
C) Sensitivity/ Cutoff Point Determination Study Summary
A Sensitivity Study
Sensitivity Study was performed to determine the cutoff point concentration at which each analyte on the TC-Thunderbolt URS-10 strip changed from negative to the positive color blocks. Samples were prepared by spiking the specified analyte concentration into negative urine with a minimum of 4 levels across the measuring range for each color block. Each pool was then analyzed in replicates of 7 by 3 operators on each of the 3 individual strip lots (7 strips x 3 operators/ strip lots), for a total of 21 data points for each level. The cutoff point determination study for each color block for each analyte is defined as the lowest concentration at which >55% of the test results are positive.
Results:
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 Concentration | % Positive Results |
|---|---|---|---|
| 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 | 0.375 mg/dL | 57% |
| Moderate | 1 mg/dL | 100% | |
| Large | 2.5 mg/dL | 57% | |
| Ketone | Trace | 3.75 mg/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% |
| Leukocyte | Trace | 15 ca cells/µL | 100% |
| Small | 56.25 ca cells/µL | 95% | |
| Moderate | 97.5 ca cells/µL | 60% |
16
| 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 | 7.0 mg/dL | 85% | |
| pH | 5.0 | 5.0 | |
| 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% |
The results for specific analyte concentration at each color block are shown below:
| | Concentration
Tested | Percentage Agreement at Each Color Block | | | | |
|---------|-------------------------|------------------------------------------|-----------|-----------|-----------|------------|
| | | Negative | 100 mg/dL | 250 mg/dL | 500 mg/dL | 1000 mg/dL |
| GLUCOSE | 25 mg/dL | 100% | 0% | 0% | 0% | 0% |
| | 50 mg/dL | 100% | 0% | 0% | 0% | 0% |
| | 75 mg/dL | 10% | 90% | 0% | 0% | 0% |
| | 100 mg/dL | 0% | 100% | 0% | 0% | 0% |
| | 137.5 mg/dL | 0% | 100% | 0% | 0% | 0% |
| | 175 mg/dL | 0% | 100% | 0% | 0% | 0% |
| | 212.5 mg/dL | 0% | 15% | 85% | 0% | 0% |
| | 250 mg/dL | 0% | 0% | 100% | 0% | 0% |
17
| 312.5 mg/dL | 0% | 0% | 100% | 0% | 0% |
|---|---|---|---|---|---|
| 375 mg/dL | 0% | 0% | 100% | 0% | 0% |
| 437.5 mg/dL | 0% | 0% | 15% | 85% | 0% |
| 500 mg/dL | 0% | 0% | 0% | 100% | 0% |
| 625 mg/dL | 0% | 0% | 0% | 100% | 0% |
| 750 mg/dL | 0% | 0% | 0% | 60% | 40% |
| 875 mg/dL | 0% | 0% | 0% | 15% | 85% |
| 1000 mg/dL | 0% | 0% | 0% | 0% | 100% |
| | Concentration
Tested | Percentage Agreement at Each Color Block | | | |
|-----------|-------------------------|------------------------------------------|-------|----------|-------|
| | | Negative | Small | Moderate | Large |
| | 0.125 mg/dL | 100% | 0% | 0% | 0% |
| | 0.25 mg/dL | 100% | 0% | 0% | 0% |
| | 0.375 mg/dL | 43% | 57% | 0% | 0% |
| | 0.5 mg/dL | 0% | 100% | 0% | 0% |
| BILIRUBIN | 0.625 mg/dL | 0% | 100% | 0% | 0% |
| | 0.75 mg/dL | 0% | 100% | 0% | 0% |
| | 0.875 mg/dL | 0% | 71% | 29% | 0% |
| | 1 mg/dL | 0% | 0% | 100% | 0% |
| | 1.5 mg/dL | 0% | 0% | 100% | 0% |
| | 2 mg/dL | 0% | 0% | 100% | 0% |
| | 2.5 mg/dL | 0% | 0% | 43% | 57% |
| | 3 mg/dL | 0% | 0% | 0% | 100% |
| | Concentration
Tested | Percentage Agreement at Each Color Block | | | | |
|--------|-------------------------|------------------------------------------|-------|----------|----------|----------|
| | | Negative | Trace | 15 mg/dL | 40 mg/dL | 80 mg/dL |
| KETONE | 1.25 mg/dL | 100% | 0% | 0% | 0% | 0% |
| | 2.5 mg/dL | 85% | 15% | 0% | 0% | 0% |
| | 3.75 mg/dL | 5% | 95% | 0% | 0% | 0% |
18
| 5 mg/dL | 0% | 100% | 0% | 0% | 0% |
|---|---|---|---|---|---|
| 7.5 mg/dL | 0% | 100% | 0% | 0% | 0% |
| 10 mg/dL | 0% | 45% | 55% | 0% | 0% |
| 12.5 mg/dL | 0% | 10% | 90% | 0% | 0% |
| 15 mg/dL | 0% | 0% | 100% | 0% | 0% |
| 21.5 mg/dL | 0% | 0% | 90% | 10% | 0% |
| 27.5 mg/dL | 0% | 0% | 45% | 55% | 0% |
| 33.75 mg/dL | 0% | 0% | 0% | 100% | 0% |
| 40 mg/dL | 0% | 0% | 0% | 100% | 0% |
| 50 mg/dL | 0% | 0% | 0% | 60% | 40% |
| 60 mg/dL | 0% | 0% | 0% | 5% | 95% |
| 70 mg/dL | 0% | 0% | 0% | 0% | 100% |
| 80 mg/dL | 0% | 0% | 0% | 0% | 100% |
| | Concentration
Tested | Percentage Agreement at Each Color Block | | | | |
|-------|-------------------------|------------------------------------------|-------|-------|----------|-------|
| | | Negative | Trace | Small | Moderate | Large |
| BLOOD | 0.008 mg/dL | 90% | 10% | 0% | 0% | 0% |
| | 0.015 mg/dL | 81% | 19% | 0% | 0% | 0% |
| | 0.023 mg/dL | 29% | 61% | 0% | 0% | 0% |
| | 0.03 mg/dL | 0% | 100% | 0% | 0% | 0% |
| | 0.043 mg/dL | 0% | 100% | 0% | 0% | 0% |
| | 0.053 mg/dL | 0% | 90% | 10% | 0% | 0% |
| | 0.064 mg/dL | 0% | 24% | 76% | 0% | 0% |
| | 0.075 mg/dL | 0% | 0% | 100% | 0% | 0% |
| | 0.116 mg/dL | 0% | 0% | 100% | 0% | 0% |
| | 0.158 mg/dL | 0% | 0% | 100% | 0% | 0% |
| | 0.199 mg/dL | 0% | 0% | 10% | 90% | 0% |
| | 0.24 mg/dL | 0% | 0% | 0% | 100% | 0% |
| | 0.368 mg/dL | 0% | 0% | 0% | 100% | 0% |
19
| 0.495 mg/dL | 0% | 0% | 0% | 100% | 0% |
|---|---|---|---|---|---|
| 0.628 mg/dL | 0% | 0% | 0% | 10% | 90% |
| 0.75 mg/dL | 0% | 0% | 0% | 0% | 100% |
| | Concentration
Tested | Percentage Agreement at Each Color Block | | | | | |
|---------|-------------------------|------------------------------------------|-------|-------------|--------------|--------------|---------------|
| | | Negative | Trace | 30
mg/dL | 100
mg/dL | 300
mg/dL | 2000
mg/dL |
| | 3.75 mg/dL | 100% | 0% | 0% | 0% | 0% | 0% |
| | 7.5 mg/dL | 55% | 45% | 0% | 0% | 0% | 0% |
| | 11.25 mg/dL | 25% | 75% | 0% | 0% | 0% | 0% |
| | 15 mg/dL | 0% | 100% | 0% | 0% | 0% | 0% |
| | 18.75 mg/dL | 0% | 90% | 10% | 0% | 0% | 0% |
| | 22.5 mg/dL | 0% | 20% | 80% | 0% | 0% | 0% |
| PROTEIN | 26.25 mg/dL | 0% | 15% | 85% | 0% | 0% | 0% |
| | 30 mg/dL | 0% | 0% | 100% | 0% | 0% | 0% |
| | 47.5 mg/dL | 0% | 0% | 100% | 0% | 0% | 0% |
| | 65 mg/dL | 0% | 0% | 5% | 95% | 0% | 0% |
| | 82.5 mg/dL | 0% | 0% | 5% | 95% | 0% | 0% |
| | 100 mg/dL | 0% | 0% | 0% | 100% | 0% | 0% |
| | 150 mg/dL | 0% | 0% | 0% | 80% | 20% | 0% |
| | 200 mg/dL | 0% | 0% | 0% | 15% | 85% | 0% |
| | 250 mg/dL | 0% | 0% | 0% | 5% | 95% | 0% |
| | 300 mg/dL | 0% | 0% | 0% | 0% | 100% | 0% |
| | 725 mg/dL | 0% | 0% | 0% | 0% | 55% | 45% |
| | 1150 mg/dL | 0% | 0% | 0% | 0% | 30% | 70% |
| | 1575 mg/dL | 0% | 0% | 0% | 0% | 10% | 90% |
| | 2000 mg/dL | 0% | 0% | 0% | 0% | 0% | 100% |
20
| | Concentration
Tested (ca
cells/µL) | Percentage Agreement at Each Color Block | | | | |
|------------|------------------------------------------|------------------------------------------|-------|-------|----------|-------|
| | | Negative | Trace | Small | Moderate | Large |
| LEUKOCYTES | 3.75 | 100% | 0% | 0% | 0% | 0% |
| | 7.5 | 100% | 0% | 0% | 0% | 0% |
| | 11.25 | 95% | 5% | 0% | 0% | 0% |
| | 15 | 0% | 100% | 0% | 0% | 0% |
| | 28.75 | 0% | 95% | 5% | 0% | 0% |
| | 42.5 | 0% | 80% | 20% | 0% | 0% |
| | 56.25 | 0% | 5% | 95% | 0% | 0% |
| | 70 | 0% | 0% | 100% | 0% | 0% |
| | 83.75 | 0% | 0% | 100% | 0% | 0% |
| | 97.5 | 0% | 0% | 40% | 60% | 0% |
| | 111.25 | 0% | 0% | 0% | 100% | 0% |
| | 125 | 0% | 0% | 0% | 100% | 0% |
| | 218.75 | 0% | 0% | 0% | 100% | 0% |
| | 312.5 | 0% | 0% | 0% | 100% | 0% |
| | 406.25 | 0% | 0% | 0% | 45% | 55% |
| | 500 | 0% | 0% | 0% | 0% | 100% |
| Concentration tested | Percentage Agreement at Each Color Block | ||
|---|---|---|---|
| Negative | Positive | ||
| NITRITE | 0.025 mg/dL | 100% | 0% |
| 0.05 mg/dL | 100% | 0% | |
| 0.075 mg/dL | 100% | 0% | |
| 0.1 mg/dL | 45% | 55% |
| | Concentration
Tested (mg/dL) | Percentage Agreement at Each Color Block | | | |
|--------------|---------------------------------|------------------------------------------|-----|-----|-----|
| UROBILINOGEN | 0.2 | 1 | 2.0 | 4.0 | 8.0 |
21
| 0.2 | 100% | 0% | 0% | 0% | 0% |
|---|---|---|---|---|---|
| 0.4 | 100% | 0% | 0% | 0% | 0% |
| 0.6 | 100% | 0% | 0% | 0% | 0% |
| 0.8 | 29% | 71% | 0% | 0% | 0% |
| 1.0 | 0% | 100% | 0% | 0% | 0% |
| 1.25 | 0% | 100% | 0% | 0% | 0% |
| 1.5 | 0% | 90% | 0% | 0% | 0% |
| 1.75 | 0% | 62% | 28% | 0% | 0% |
| 2.0 | 0% | 10% | 90% | 0% | 0% |
| 2.5 | 0% | 0% | 100% | 0% | 0% |
| 3.0 | 0% | 0% | 100% | 0% | 0% |
| 3.5 | 0% | 0% | 45% | 55% | 0% |
| 4.0 | 0% | 0% | 0% | 100% | 0% |
| 5.0 | 0% | 0% | 0% | 100% | 0% |
| 6.0 | 0% | 0% | 0% | 80% | 20% |
| 7.0 | 0% | 0% | 0% | 15% | 85% |
| 8.0 | 0% | 0% | 0% | 0% | 100% |
| | Concentration
Tested | Percentage Agreement at Each Color Block | | | | | | |
|----|-------------------------|------------------------------------------|-----|-----|-----|-----|------|------|
| | | 5.0 | 6.0 | 6.5 | 7.0 | 7.5 | 8.0 | 8.5 |
| pH | 5.0 | 95% | 5% | 0% | 0% | 0% | 0% | 0% |
| | 6.0 | 5% | 95% | 0% | 0% | 0% | 0% | 0% |
| | 6.5 | 0% | 0% | 95% | 0% | 0% | 0% | 0% |
| | 7.0 | 0% | 0% | 5% | 95% | 0% | 0% | 0% |
| | 7.5 | 0% | 0% | 0% | 5% | 95% | 0% | 0% |
| | 8.0 | 0% | 0% | 0% | 0% | 5% | 100% | 0% |
| | 8.5 | 0% | 0% | 0% | 0% | 0% | 5% | 100% |
| | Concentration
Tested | Percentage Agreement at Each Color Block | | | | | |
|----|-------------------------|------------------------------------------|-------|-------|-------|-------|-------|
| SG | | 1.005 | 1.010 | 1.015 | 1.020 | 1.025 | 1.030 |
22
| 1.000 | 100% | 0% | 0% | 0% | 0% | 0% |
|---|---|---|---|---|---|---|
| 1.005 | 100% | 0% | 0% | 0% | 0% | 0% |
| 1.010 | 0% | 100% | 0% | 0% | 0% | 0% |
| 1.015 | 0% | 0% | 100% | 0% | 0% | 0% |
| 1.020 | 0% | 0% | 0% | 100% | 0% | 0% |
| 1.025 | 0% | 0% | 0% | 0% | 100% | 0% |
| 1.030 | 0% | 0% | 0% | 0% | 0% | 100% |
D) Linearity Study/ Assay Reportable Range Study Summary:
The linear range of TC-Thunderbolt Automated Urine Analyzer was evaluated by measuring negative urine and negative urine spiked with known increasing concentrations of analytes relative to each color block covering the entire measuring range of each analyte present on the TC-Thunderbolt URS-10 strip. Sample measurement was performed in replicates of 7 by 3 operators on each of 3 individual strip lots (7 strips x 3 operators/ strip lots), for a total of 21 measurements for every sample tested. A pH meter was used to confirm the pH results. The specific gravity values were confirmed by a clinical, handheld refractometer. A specific gravity reading of 1.000 was obtained from distilled water. Specific gravity measurements were performed in replicates of 7 by 3 operators on each of 3 individual strip lots (7 strips x 3 operators/ strip lots), for a total of 21 measurements for every sample tested. Results:
The linear range of the TC-Thunderbolt Automated Urine Analyzer is summarized in the table below:
| Analyte | TC-Thunderbolt Output Block | Measuring Range |
|---|---|---|
| Glucose | Negative | 0.0 - 75 mg/dL |
| 100 mg/dL | 75 - 212.5 mg/dL | |
| 250 mg/dL | 212.5 - 437.5 mg/dL | |
| 500 mg/dL | 437.5 - 875 mg/dL | |
| 1000 mg/dL | > 875 mg/dL | |
| Bilirubin | Negative | 0.0 - 0.375 mg/dL |
| Small | 0.375 - 1.0 mg/dL | |
| Moderate | 1.0 - 2.5 mg/dL | |
| Large | > 2.5 mg/dL | |
| Ketone | Negative | 0.0 - 3.75 mg/dL |
| Trace | 3.75 - 10.0 mg/dL | |
| 15 mg/dL | 10.0 - 27.5 mg/dL | |
| 40 mg/dL | 27.5 - 60.0 mg/dL | |
| 80 mg/dL | > 60.0 mg/dL | |
| Blood | Negative | 0.0 - 0.023 mg/dL |
| Trace | 0.023 - 0.064 mg/dL | |
| Small | 0.064 - 0.199 mg/dL | |
| Moderate | 0.199 - 0.628 mg/dL | |
| Large | > 0.628 mg/dL | |
| Negative | 0.0 - 11.25 mg/dL | |
| Trace | 11.25 - 26.25 mg/dL | |
| Protein | 30 mg/dL | 26.25 - 82.5 mg/dL |
| 100 mg/dL | 82.5 - 200 mg/dL | |
| 300 mg/dL | 200 - 1150 mg/dL | |
| 2000 mg/dL | > 1150 mg/dL | |
| Nitrite | Negative | 0.0 - 0.1 mg/dL |
| Positive | > 0.1 mg/dL | |
| Leukocyte | Negative | 0.0 - 15 ca cells/µL |
| Trace | 15 - 56.25 ca cells/µL | |
| Small | 56.25 - 97.5 ca cells/µL | |
| Moderate | 97.5 - 406.25 ca cells/µL | |
| Large | > 406.25 ca cells/µL | |
| Urobilinogen | 0.2 mg/dL | 0.2 - 0.6 mg/dL |
| 1.0 mg/dL | 0.8 - 1.5 mg/dL | |
| 2.0 mg/dL | 2.0 - 3.0 mg/dL | |
| 4.0 mg/dL | 3.5 - 6.0 mg/dL | |
| 8.0 mg/dL | 7.0 - 8.0 mg/dL | |
| pH | 5.0 | 5.0 |
| 6.0 | 6.0 | |
| 6.5 | 6.5 | |
| 7.0 | 7.0 | |
| 7.5 | 7.5 | |
| 8.0 | 8.0 | |
| 8.5 | 8.5 | |
| SG | 1.005 | 1.005 |
| 1.010 | 1.010 | |
| 1.015 | 1.015 | |
| 1.020 | 1.020 | |
| 1.025 | 1.025 | |
| 1.030 | 1.030 |
23
E) Analytical Specificity and Interference
24
Interfering substance studies were performed to assess the interfering effect of various substances on the TC-Thunderbolt URS-10 strips used on the TC-Thunderbolt Automated Urine Analyzer. Urine sample pools were prepared at 2 concentrations for each urine chemistry analyte; negative and positive. The negative sample pools had no analyte present while the positive sample pools were prepared by spiking each analyte into negative urine at the concentrations listed below:
| Analyte | Concentrations to be Tested | ||
|---|---|---|---|
| Negative | Positive | Unit | |
| Glucose | 0 | 100 | mg/dL |
| Protein | 0 | 30 | mg/dL |
| Bilirubin | 0 | 0.5 | mg/dL |
| Urobilinogen | 0 | 2 | mg/dL |
| pH | 6.0 | 7.0 | - |
| Blood | 0 | 0.24 | mg/dL |
| Ketone | 0 | 15 | mg/dL |
| Nitrite | 0 | 0.10 | mg/dL |
| Leukocytes | 0 | 125 | ca Cells/µL |
Concentration of Samples Tested
Each urine sample was tested with 3 replicates using TC-Thunderbolt Urine Analyzer System and a mean result was calculated. The mean result from samples with no interfering substance was compared against the mean result of the sample spiked with the interfering substance at the stated concentration. Interference was defined as a change in output of ± 1 color blocks between spiked control sample. For pH, interference was defined as a change of ± 2 color blocks between the 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 of substance tested
which demonstrated no Interference |
|---------------------------------|---------------------------------------------------------------------------------|
| Ascorbic Acid | 10 mg/dL |
| Ammonium 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 |
25
| Tetracycline | 100 mg/dL |
|---|---|
| -------------- | ----------- |
The following table shows the substances which did interfere with one or more of the TC-Thunderbolt URS-10 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 | Ascorbic Acid ≥ 30 mg/dL | -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, -1 |
| Nitrite | D(+) Glucose ≥ 2000 mg/dL | -1 |
| Leukocytes | D(+) Glucose ≥ 2000 mg/dL, Ascorbic Acid ≥ 30
mg/dL | -1 |
| Ketone | MESNA ≥ 50 mg/dL, | +3 |
| pH | Acetoacetate ≥ 60 mg/dL, Oxalic Acid ≥ mg/dL,
Citric Acid ≥ 130 mg/dl | +1, -1, -1 |
Based on the results of this testing the sponsor has included the effects from above interfering substances in the labeling as limitations of procedure.
4.10) Shelf Life Studies:
A) Accelerated Stability Study Summary
Accelerated study was performed on closed bottles of TC-Thunderbolt URS-10 strips as a means of assessing the shelf-life of the closed product, which is verified in real time studies. This study involves testing the device once per week periodically, for the duration of the study using Urine Control Solutions Levels I, II and III. TC-Thunderbolt URS-10 bottles used in the Stressed Study will have passed Quality Control inspection and stored at 37°C ± 2°C.
Acceptance Criteria:
The TC-Thunderbolt URS-10 strips must pass Quality Control testing for ≥ 90 days to confirm the closed bottle shelf life of two (2) years at room temperature (15-30°C) with 20-30% humidity.
Results:
Three lots of TC-Thunderbolt URS-10 strips all passed Quality Control testing for 91 days at 37°C ± 2°C. The expected shelf life of the TC-Thunderbolt URS-10 strips is 28 months based on the Accelerated Stability Study Test Results.
B) Real-time Stability Study Summary:
26
A real time, temperature and humidity stability study is currently being performed on closed bottles of TC-Thunderbolt URS-10 strips to validate the claims stated in the Stress Stability Studies. This study involves testing the TC-Thunderbolt URS-10 strips using Urine Control Solutions Levels I, II and III for every six (6) months from the manufactured date, until 18 months. After the TC-Thunderbolt URS-10 strips has passed 18 months, test every three (3) months until the product fails or until 28 months. Three (3) lots of TC-Thunderbolt URS-10 strips used in the Real Time Shelf Life Study will have passed Quality Control inspection and are being kept at room temperature (15-30°C) and 20-30% humidity.
Acceptance Criteria: The product must pass Quality Control testing in real-time through its expiration date in the conditions that the product will be stored: closed bottle, room temperature (15-30°C)
Result:
This study is currently on-going. The three lots of TC-Thunderbolt URS-10 strips have passed the 12 months Quality Control testing and we plan to continue testing until 28 months.
C) Open-vial Stability Study Summary:
Open-vial Study was performed on opened bottles (broken seal) of TC-Thunderbolt URS-10 strips as a means of assessing the shelf-life of the opened bottle product once the seal is broken. This study involves testing the device once per week periodically, for the duration of the study using Urine Control Solutions Levels I, II and III. TC-Thunderbolt URS-10 bottles used in the Open-vial Study will have passed Quality Control inspection and are opened (seals broken) and stored at room temperature (15-30°C) and 20-30% humidity.
Acceptance Criteria:
The TC-Thunderbolt URS-10 strips must pass Quality Control testing for ≥ 90 days to confirm the opened bottle shelf life of 3 months at room temperature (15-30°C) with 20-30% humidity.
Result:
Three lots of Open Vial TC-Thunderbolt URS-10 strips all passed Quality Control testing for 91 days at 15-30°C. The expected shelf life of the Open Vial TC-Thunderbolt URS-10 strips is 90 days based on the Open Vial Stability Study Test Results.
4.11) Conclusion:
The performance characteristics of the TC-Thunderbolt Automated Urine Analyzer System were verified by method comparison, precision, sensitivity and cutoff point determination, linearity/ assay reportable range, analytical specificity and interference, shelf life and stress studies. Testing results indicate that the TC-Thunderbolt Automated Urine Analyzer System perform satisfactorily when used appropriately, as outlined in the package insert.