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510(k) Data Aggregation
(360 days)
URS-2GP (GLUCOSE PROTEIN) URINE STRIPS
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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