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The DIASCREEN® Reagent Strip for Urinalysis is a dip-and-read test strip for semi-quantitative urinalysis. DIASCREEN® Reagent Strips have been developed to allow health care professionals to test semi-quantitatively for patient urine levels of specific gravity. ketone, glucose, protein, blood, leukocytes, nitrite, pH, bilirubin, and urobilinogen by visual comparison with a color chart.

The DIASCREEN® Reagent Strip for Urinalysis is a dip-and-read test strip and is intended for use as an in vitro diagnostic aid using urine specimens. The strip contains solid phase reagent areas affixed to a plastic strip and is provided in a dry reagent format.

The strip provides qualitative and semi-quantitative tests for specific gravity, ketones, glucose, protein, blood, leukocytes, nitrite, pH, bilirubin, and urobilinogen by visual comparison with a color chart for each concentration range. No additional reagents and laboratory equipment are required. The reagent strips are packaged in a plastic vial containing a desiccant. The test strips must be kept tightly capped in the vial to assure reagent reactivity. The directions must be followed exactly and it is necessary to use fresh, well-mixed, uncentrifuged urine for optimal results.

DIASCREEN® Reagent Strips are plastic strips to which are affixed reagent test areas. Several product configurations are included with this submission, but all configurations are limited to one, some or all of the following tests: specific gravity, ketone, glucose, protein, blood, leukocytes, nitrite, pH, bilirubin, and urobilinogen.

The reagent test areas on the DIASCREEN® Reagent Strips are ready to use upon removal from the bottle and the entire reagent strip is disposable after use. The strips are to be read visually, requiring no additional laboratory equipment for testing.

This document describes the DIASCREEN® Reagent Strip System for urinalysis, a dip-and-read test strip for semi-quantitative urinalysis.

1. Table of Acceptance Criteria and Reported Device Performance:

The acceptance criteria are not explicitly stated as numerical targets the device must meet in the provided text. Instead, the study aims to demonstrate substantial equivalence by showing high agreement (within the same color block or within one color block) between the DIASCREEN® Reagent Strips and a legally marketed predicate device (Bayer Multistix 10 SG). The reported device performance is presented as the percentage of agreement.

Here's a table summarizing the performance data, with the understanding that the "acceptance criteria" are implied by the observed high percentages of agreement with the predicate device.

Note: The document also reports cross-lot consistency for DIASCREEN® (Lot 1 vs. Lot 2), showing high agreement (91-100% within the same color block and 100% within 1 color block).

2. Sample Size and Data Provenance:

• Test Set Sample Size: 53 fresh urine samples.
• Data Provenance: The urine samples were obtained from a "mixed patient population" at a "medical facility." The study was conducted in the US at Wichita State University (Kansas), though the manufacturer is based in Korea. The study appears to be prospective, as fresh urine samples were obtained and tested for the evaluation.

3. Number of Experts and Qualifications for Ground Truth:

The document does not explicitly state the number of experts used for establishing ground truth, nor their specific qualifications beyond the study director, James Jackson MT(ASCP) CLS, Ph.D. While the study director is qualified, it's not indicated if he acted as the sole expert for all ground truth determinations or if additional, similarly qualified personnel were involved in reading the strips and/or performing confirmation tests.

4. Adjudication Method for the Test Set:

The study involved a comparison between the DIASCREEN® Reagent Strips and the Bayer Multistix 10 SG. When data between the two products did not agree within one color block, an "alternate procedure" (confirmation test) was used. This implies an adjudication process where a third, more definitive method resolved discrepancies between the initial two readings.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The study compares the performance of the DIASCREEN® strips to a predicate device and to confirmative tests, not the improvement of human readers with vs. without AI assistance. The device is a visual dip-and-read strip, not an AI-assisted diagnostic tool in the sense of image analysis software.

6. Standalone Performance Study:

Yes, a standalone performance study was done in the sense that the performance of the DIASCREEN® Reagent Strips themselves was evaluated independently against comparator methods and against a predicate device. The results are based on visual comparison with a color chart, which is the intended standalone use of the device. The study evaluates the algorithm of the test strip (i.e., its chemical reactions and color development) and the visual interpretation of results.

7. Type of Ground Truth Used:

The ground truth for the test set was established using a combination of:

• Predicate Device Comparison: Bayer Multistix 10 SG was used as a primary comparator.
• Confirmatory (Reference) Tests: For discrepancies (data not agreeing within one color block between DIASCREEN® and Bayer), specific confirmation tests were employed for each analyte:
  • Specific Gravity: Refractometer
  • Leukocyte: Microscopic Evaluation, CHEMSTRIP (Boehringer Mannheim)
  • pH: pH Meter
  • Blood: Microscopic Evaluation, CHEMSTRIP (Boehringer Mannheim), Ascorbic Acid Test/Urispec (Henry Schein)
  • Nitrite: Microscopic Evaluation, CHEMSTRIP (Boehringer Mannheim)

8. Sample Size for the Training Set:

The document does not provide information about a "training set" or its sample size. This type of device (visual reagent strip) does not typically involve machine learning or AI models that require specific training sets in the computational sense. The "development" of the strips would involve chemical formulation and calibration, rather than algorithmic training on a dataset.

9. How Ground Truth for the Training Set Was Established:

As no "training set" in the context of AI/machine learning is described, there is no information on how its ground truth was established. The "ground truth" for the performance evaluation in this document refers to the established values obtained from the predicate device and the confirmatory reference methods on the test set of urine samples.

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