(360 days)
The URS-2GP (Glucose Protein) Urine Strips are visually read, semi-quantitative tests for the detection of glucose and protein in urine and are intended for prescription home use. Test results may provide information regarding the status of carbohydrate metabolism and kidney function.
This device consists of glucose and protein reagent pads that are affixed onto firm plastic strips. The reagent pad areas are made of absorbent material saturated with chemically active substance, then dried and affixed to the plastic strip with double-sided adhesive. Each strip is carefully packaged individually along with a desiccant in a sealed, foiled pouch. A packaged along with the foil pouches into a box. The package insert contains all the necessary product information. Results of each test is based on the color produced from the reaction of each reagent pad area once the reagent strip comes into contact with a urine sample. Each parameter is color coded accordingly as described in the color chart. Results can be obtained in clinically meaningful units directly, by comparison with the color chart on the foil pouch. The color blocks represent different concentrations of urine glucose and urine protein. The entire reagent strip is disposable following federal and local regulations. Laboratory instrumentation is not required.
The provided text describes the URS-2GP (Glucose Protein) Urine Strips and their performance based on studies conducted for 510(k) clearance. Here's a breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state "acceptance criteria" as a separate, pre-defined set of thresholds. Instead, it presents the study results as demonstrating substantial equivalence to the predicate device. The key performance metrics reported are agreement rates. Based on the "Summary of Clinical Tests Performed" and "Precision" sections, the implied performance targets (or observed performance that supports equivalence) are high agreement rates.
| Performance Metric | Acceptance Criteria (Implied) | Reported Device Performance | Test Parameter |
|---|---|---|---|
| Clinical Agreement (Exact Match) | High agreement (e.g., >90%) | 92% agreement (clinical study by lay users vs. professional use of predicate) | Glucose & Protein |
| Clinical Agreement (Within One Color Block) | Very high agreement (e.g., 100%) | 100% agreement (clinical study by lay users vs. professional use of predicate) | Glucose & Protein |
| Precision (Exact Match) | High agreement (e.g., >90%) | 96% agreement (laboratory precision study) | Glucose & Protein |
| Precision (Within One Color Block) | Very high agreement (e.g., 100%) | 100% agreement (laboratory precision study) | Glucose & Protein |
| Sensitivity | 95% of results yield correct concentrations within range | Established by testing at various concentrations near each color block | Glucose & Protein |
| Specificity (Glucose) | No reaction with analogues | Did not react with galactose, fructose, sucrose up to 500 mg/dL | Glucose |
| Specificity (Protein) | Specificity for albumin, minimal reaction with analogues | Specific for albumin; some reactivity to globulin and Bence-Jones protein >100 mg/dL | Protein |
| Interference | No interference leading to off-by-one color block reading | Ascorbic acid (50 mg/dL) & MESNA (25 mg/dL) interfered with glucose; MESNA (25 mg/dL) interfered with protein; Hemoglobin (>100 mg/dL) invalidates both. | Glucose & Protein |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size (Clinical Study): 162 lay users.
- Data Provenance: The document states, "A comparison study was performed at three clinical sites..." implying prospective data collection. The country of origin is not explicitly stated, but the submission is to the FDA in the USA, so it's likely the studies were conducted within the US or under US regulatory standards.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
For the clinical comparison study, the ground truth was established by "healthcare professionals testing the sample using a comparator device (URS-3, Teco Diagnostics)." The number of professionals is not specified, nor are their specific qualifications (e.g., radiologist with 10 years of experience). However, "healthcare professionals" implies trained medical personnel who would be competent in performing and interpreting such tests.
4. Adjudication Method for the Test Set
The document does not describe an explicit adjudication method (e.g., 2+1, 3+1). The "ground truth" (or reference) for the clinical study was established by healthcare professionals using the predicate device, against which the lay users' results with the new device were compared. This implies a direct comparison rather than a consensus-based adjudication process for the test set interpretations.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
No, an MRMC comparative effectiveness study involving AI assistance for human readers was not done. This device is a visually-read urine strip, and the comparison was between lay users with the new device and healthcare professionals with a predicate device. There is no AI component mentioned.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
No, a standalone algorithm study was not done. The device is a visually-read reagent strip that requires human interpretation of color changes against a color chart.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
- Clinical Study: The ground truth for the clinical comparison study was based on the results obtained by "healthcare professionals testing the sample using a comparator device (URS-3, Teco Diagnostics)." This can be considered a form of expert interpretation using a legally marketed device as a reference standard.
- Laboratory Studies (Precision, Sensitivity, Specificity, Interference): For these studies, the ground truth would have been established using controlled urine samples with known concentrations of analytes and interfering substances, likely prepared and verified in a laboratory setting.
8. The Sample Size for the Training Set
The document does not mention "training sets" in the context of machine learning or AI. This is a traditional diagnostic device where performance is evaluated through clinical and laboratory studies, not by training an algorithm. Therefore, this question is not applicable.
9. How the Ground Truth for the Training Set was Established
As there is no mention of a "training set" in the context of an AI/ML algorithm, this question is not applicable. The device's formulation and performance characteristics were developed and validated through laboratory and clinical testing, as described above.
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510(k) Summarv
MAY 2 9 2014
[As required by 21 CFR 807.92(c)]
The assigned 510(k) number is K131600
Submitter Identification:
Teco Diagnostics 1268 N. Lakeview Avenue Anaheim, CA 92807 Establishment Registration #1832216
Contact Name:
Steve Partono, Ph.D.
Device Proprietary Name:
URS-2GP (Glucose Protein) Urine Strips
Device Common Names:
Urine Reagent Strips (URS)
Regulation Section and Classification:
21 CFR 862.1340 Urinary Glucose (non-quantitative) test system; Class II; Product Code JIL
21 CFR 862.1645 Urinary Protein or albumin (non-quantitative) test system; Class I; Product Code JIR
Review Panel: Clinical Chemistry (75)
Predicate Device:
Urine Reagent Strip-3 Parameter, K940469 Teco Diagnostics, 1268 N. Lakeview Avenue, Anaheim, CA 92807
Intended Use:
The URS-2GP (Glucose Protein) Urine Strips are visually read, semi-quantitative tests for the detection of glucose and protein in urine and are intended for prescription home use. Test results may provide information regarding the status of carbohydrate metabolism and kidney function.
Device Description:
This device consists of glucose and protein reagent pads that are affixed onto firm plastic strips. The reagent pad areas are made of absorbent material saturated with chemically active substance, then dried and affixed to the plastic strip with double-sided adhesive. Each strip is carefully packaged individually along with a desiccant in a sealed, foiled pouch. A packaged along with the foil pouches into a box. The package insert contains all the necessary product information.
Results of each test is based on the color produced from the reaction of each reagent pad area once the reagent strip comes into contact with a urine sample. Each parameter is color coded accordingly as described in the color chart. Results can be obtained in clinically meaningful units directly, by comparison with the color chart on the foil pouch. The color blocks represent different concentrations of urine glucose and urine protein. The entire reagent strip is disposable following federal and local regulations. Laboratory instrumentation is not required.
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Test Principles:
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 causing the color to change from blue-green for a "negative" reaction to greenish-brown through brown for a "positive" reaction.
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.
Expected Results:
Glucose: Small amounts of glucose are normally excreted by the kidney. Glucose concentrations up to 100 mg/dL are considered normal, but may be abnormal if found consistently.
Protein: Small amounts of protein may be excreted by the normal kidney. Protein concentrations up to 15 mg/dL are considered normal, but may be abnormal if found consistently.
Substantial Equivalence
Based on a comparison of the device features, materials and intended use, this device is substantially equivalent to the following predicate device:
Predicate Device name: URINE REAGENT STRIP-3 PARAMETER Predicate 510(k) no: K940469
Comparison with Predicate
Table 1: Comparison between New Device and Predicate Device
| URS-2GP (Glucose Protein) UrineStrips | Predicate | |
|---|---|---|
| Intended Use | The URS-2GP (Glucose Protein) UrineStrips are visually read, semi-quantitativetests for the detection of glucose andprotein in urine and are intended forprescription home use. Test results mayprovide information regarding the statusof carbohydrate metabolism and kidneyfunction. | The URS-3 provide tests for semi-quantitative determination of glucose,protein and pH in urine. |
| Human Factor | Lay users, Prescription Home Use | Professional use, POC use |
| Manufacturer | Teco Diagnostics, Inc. | Same. |
| Size | 108mmx10mm strip, 10mmx10mm pads | 80mmx5mm strip, 5mmx5mm pads |
| Packaging | Individual foil pouch, box of 25 pouches | Bottle of 100 strips |
| Storage | 15-30°C | Same |
| Test time | Glucose (30s), Protein (1 min) | Glucose (30s), Protein (1 min) |
| SampleHandling | Random urine (mid-stream). | Random urine (dipped). |
| Measurement | Visual inspection. | Visual Inspection. |
| Test Principle | Glucose: This test is based on a doublesequential enzyme reaction usingglucose oxidase and peroxidase. | Same |
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| Protein: This test is based on the proteinerror-of-indicator principle. At a constantpH, tetrabromophenol blue binds withprotein and form green color. | Same |
|---|---|
| -------------------------------------------------------------------------------------------------------------------------------------------------------------------- | ------ |
The two devices are based on same formulations, with similar performance characteristics. The main differences are 1) the URS-2GP is intended for prescription home use whereas the predicate device is intended for professional use, 2) the new device works using "mid-stream" method whereas the predicate device works using a "dip" method, and 3) the new device is individually packaged in a pouch whereas the predicate device is packaged in a bottle.
Summary of Clinical Tests Performed
A comparison study was performed at three clinical sites by having lay users (n= 162) testing the URS-2GP using mid-stream urine samples, and healthcare professionals testing the sample using a comparator device (URS-3, Teco Diagnostics). The participants were asked to match the test colors with specific color blocks on the color chart and record the glucose and protein values. The data presented here showed that the tests performed by lay users had 92% agreement based on exact match and 100% agreement within one color block.
Summary of Laboratory Tests Performed
The laboratory studies were conducted in house and included sensitivity, precision, interference, stress and stability studies. The obtained laboratory data indicated that the new device had the similar performance characteristics as the predicate device.
Precision
Multiple tests were performed under variable conditions using multiple users, sites and lots of urine controls. The tests were performed using Within Run method (multiple runs within a day) and Run-to-Run method (multiple runs on multiple days). The results showed that the device has 96% agreement based on exact match and 100% agreement within one color block).
Sensitivity
The sensitivity range for each color block was determined by performing multiple tests at various concentrations of analyte near each color block. Sensitivity range of a color block is determined by the concentrations where 95% of the test results vielded correct results.
Specificity
The device was tested with compounds similar to glucose and protein to determine if it has crossreactivity. The glucose analogues tested included galactose, fructose, and sucrose, while the protein analogues tested included globulin, hemoglobin, Bence Jones, and mucoprotein. The glucose test did not react with any of the glucose analogues at concentrations up to 500 mg/dL. The protein test was specific for albumin, but also had some reactivity to globulin and Bence-Jones protein at concentrations higher than 100 mg/dL.
Interference
The device was tested in the presence of potential interfering compounds which may affect the urine glucose and urine protein tests. A substance is considered to cause interference if the addition of the substance causes the test reading to be off by at least one color block. The results showed that ascorbic acid (50 mg/dL) and MESNA (25 mg/dL) had intefference effect on the urine glucose test. MESNA (25 mg/dL) also had interference effect on the urine protein test, while ascorbic acid up to 500 mg/dL had no effect on the urine protein test. Hemoglobin concentration of 100 mg/dL or above causes atypical color of urine which renders the urine glucose and urine protein tests invalid.
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Conclusions
The data presented demonstrate that URS-2GP (Glucose Protein) Urine Strip is substantially equivalent to URS-3. The two devices are based on same formulations, with similar performance characteristics. The clinical results also demonstrate a high correlation between URS-2GP and the URS-3 even though the new device was tested by lay users while the predicate device was tested by professional users.
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Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
May 29, 2014
TECO DIAGNOSTICS STEVE PARTONO DIRECTOR OF RESEARCH AND DEVELOPMENT 1268 NORTH LAKEVIEW AVE. ANAHEIM CA 92807
Re: K131600
Trade/Device Name: URS-2GP (Glucose Protein) Urine Strips Regulation Number: 21 CFR 862.1340 Regulation Name: Urinary glucose (nonquantitative) test system Regulatory Class: II Product Code: JIL, JIR Dated: April 30, 2014 Received: April 30, 2014
Dear Dr. Steve Partono:
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 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.
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Page 2-Mr. Steve Partono
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/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR 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.ida.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Courtney H. Lias -S
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
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
510(k) Number (if known) K131600
Device Name
URS-2GP (Glucose Protein) Urine Strips
Indications for Use (Describe)
The URS-2GP (Glucose Protein) Urine Strips are visually read, semi-quantitative tests for the detection of glucose and protein in urine and are intended for prescription home use. Test results may provide information regarding the status of carbohydrate metabolism and kidney function.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
ال Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signalure)
Ruth A. Chesler -S
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§ 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.