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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.

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.

The provided document describes the DIASCREEN® Reagent Strip System, focusing on the new leukocyte reagent area. The study aims to demonstrate substantial equivalence to previously approved devices.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for substantial equivalence are based on a clinical correlation study comparing the DIASCREEN® Leukocyte Reagent Strips to the Bayer Multistix 10 SG. The performance is reported as the percentage of responses falling within the same color block and within plus or minus one color block compared to the predicate device.

Note: The document implies "substantial equivalence" as the primary acceptance criterion, rather than specific numerical cutoffs. The reported performance demonstrates a strong agreement with the predicate device.

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size for Leucocyte Test (Comparison to Bayer Multistix):
  • Evaluation One: 39 fresh urine samples (for each of the two DIASCREEN® lots tested).
  • Evaluation Two: 279 fresh urine samples.
• Data Provenance: Prospective. Fresh urine samples were obtained at a medical facility for Evaluation One and at two clinical sites for Evaluation Two. The origin country is not explicitly stated, but the contact person and institutions (Wichita State University, Technovations Inc.) suggest the United States.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

The ground truth for the test set was established by the results obtained from the "510(k) approved" marketed urinalysis strip system, specifically the Bayer Multistix 10 SG Reagent Strips. The readings of the DIASCREEN® strips were then visually compared to the DIASCREEN® color chart, which would presumably be interpreted by trained laboratory personnel.

• No specific "experts" were used to establish a separate ground truth. Instead, the predicate device (Bayer Multistix 10 SG) acted as the reference standard.
• For Evaluation One, the study was under the direction of James Jackson, MT(ASCP) CLS, Ph.D. at Wichita State University Department of Medical Technology. This individual possesses medical technology qualifications.
• For Evaluation Two, the study was conducted under the direction of Myron Rapkin, Technovations Inc. No specific qualifications are listed for this individual in the provided text.

4. Adjudication Method for the Test Set

The adjudication method was a direct comparison between the visual readings of the DIASCREEN® Reagent Strips using their own color chart and the results from the Bayer Multistix 10 SG Reagent Strips. There is no mention of an independent adjudication panel or consensus process.

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, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This device is a manual, visual dip-and-read test strip, not an AI-assisted system.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

No, a standalone algorithm-only performance study was not done. The device is a visual dip-and-read test strip that requires human interpretation of color changes against a color chart.

7. The Type of Ground Truth Used

The ground truth used was the performance of a legally marketed and "510(k) approved" predicate device: the Bayer Multistix 10 SG Reagent Strips. This is a form of comparative ground truth against another validated diagnostic method rather than an absolute "expert consensus," "pathology," or "outcomes data" ground truth for the condition itself.

8. The Sample Size for the Training Set

The document does not specify a separate "training set" or "validation set" in the context of the clinical evaluation. The reported evaluations appear to be performance studies for verification rather than training a machine learning model. The strips were developed using established chemical reagents and principles.

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

Not applicable, as a discrete training set with explicitly established ground truth (in the AI context) is not described for this type of medical device submission. The device design and reagent compositions were likely developed based on known chemical reactions and prior experience with similar urinalysis strips.

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