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510(k) Data Aggregation
(82 days)
DIASCREEN REAGENT STRIPS FOR URINALYSIS, MODELS D122OO (2GK), D12100 (1K), D11100 (1G)
DiaScreen® Reagent Strips for Urinalysis are intended for the qualitative and semi-quantitative measurement of glucose in urine. These measurements are used in the screening and diagnosis of glucose metabolism disorders including diabetes mellitus, hypoglycemia, and hyperglycemia.
DiaScreen® Reagent Strips for Urinalysis are intended for the qualitative and semi-quantitative measurement of ketones in urine. Identification of ketones is used in the qualitative measurement of acidosis or ketosis and for monitoring patients on ketogenic diets and patients with diabetes.
Testing can be done by dipping the Reagent Strips into a specimen container or by holding them directly in the urine stream.
The glucose and ketone strips are intended for both professional and over-the-counter use.
DiaScreen® Reagent Strips for Urinalysis are plastic strips coated with one or more dry reagents. Each reagent is specific for a particular analyte. Reagent areas are spaced along the test strip, with a physical gap between reagent areas. Three configurations are designed for both professional and home use: detecting one or both of the following analytes: glucose, ketone. The dry reagents change color in reaction to the presence, and concentration, of their associated analyte. The strips are read visually against a color chart.
The provided 510(k) summary for the DiaScreen® Reagent Strips for Urinalysis does not contain detailed information about specific acceptance criteria or a comprehensive study report with quantitative data to definitively prove the device meets those criteria.
However, based on the available text, we can infer some aspects and highlight what is missing.
Here's an attempt to answer your questions based on the provided text, along with notes about information that is not available:
1. Table of Acceptance Criteria and Reported Device Performance
| Criterion Type | Acceptance Criteria (Inferred/Not Stated) | Reported Device Performance | Notes/Missing Information |
|---|---|---|---|
| Accuracy (Home Use) | Not explicitly stated (e.g., specific sensitivity/specificity thresholds) | "home users can obtain accuracy which is substantially equivalent to that obtained by professional users." | This is a qualitative statement of equivalence. No numerical accuracy metrics (e.g., percent agreement, sensitivity, specificity, PPV, NPV) are provided for either home users or professional users, nor are the specific acceptance thresholds for these metrics. |
| Precision/Reproducibility | Not explicitly stated | Not reported | No data on the variability of results within or between users, or over time. |
| Interfering Substances | Not explicitly stated | Not reported | No information on potential interferences from common urine components, medications, or other substances that might affect test results. |
| Stability (Shelf-life) | Not explicitly stated | Not reported | No data on the stability of the reagent strips over their shelf-life under various storage conditions. |
| Readability of Color Chart | Not explicitly stated (e.g., clear distinction between color blocks) | Implied to be sufficient for visual reading. | No specific validation of the color chart's clarity or ease of interpretation for untrained users. |
| Equivalence to Predicate Device | Substantial equivalence to the existing "DiaScreen® Reagent Strips for Urinalysis" | Implied by the FDA's 510(k) clearance: "device is substantially equivalent" | While the FDA has determined substantial equivalence, the specific performance metrics used to support this for the new labeling for OTC use are not detailed here. The primary claim for this submission seems to be the change in intended use/labeling to include OTC home use. |
2. Sample Size Used for the Test Set and the Data Provenance
- Sample Size: Not specified. The document only mentions "Clinical data" and "Testing demonstrated," but provides no numbers for participants or urine samples for any clinical study.
- Data Provenance: Not specified (e.g., country of origin). The study is simply referred to as "Clinical testing." It is implied to be prospective, as it involves home users obtaining results, likely comparing them to professional users.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
- Number of Experts: Not specified.
- Qualifications of Experts: Not specified. The document refers to "professional users," implying healthcare professionals, but their specific titles, years of experience, or training for interpreting these strips are not detailed.
4. Adjudication Method for the Test Set
- Adjudication Method: Not specified. It is unclear how discrepancies between home user results and professional user results (or any other ground truth) were resolved, or if any formal adjudication process was used.
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
- MRMC Study: No. This device is a visual dipstick test, not an AI-powered diagnostic imaging or interpretation system. Therefore, an MRMC study comparing human readers with and without AI assistance is not applicable and was not performed.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Standalone Performance: Not applicable. This is a manual, visually interpreted test strip. There is no "algorithm only" performance to evaluate. The performance is inherently tied to human visual interpretation.
7. The Type of Ground Truth Used
- Type of Ground Truth: The document implies that the ground truth for home user performance was based on the results obtained by "professional users." This suggests a comparison to a referent standard performed by trained personnel, likely using the same DiaScreen® Reagent Strips or a laboratory reference method. However, the exact nature of this "ground truth" (e.g., whether professional user results were cross-referenced with a lab analyzer, pathology, or confirmed clinical outcomes) is not specified.
8. The Sample Size for the Training Set
- Training Set Sample Size: Not applicable. This is not an AI/machine learning device that requires a training set. The device's performance relies on the inherent chemical reactions on the strip and visual interpretation against a color chart.
9. How the Ground Truth for the Training Set was Established
- Training Set Ground Truth: Not applicable, as there is no training set for this type of device.
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