(52 days)
Urinalysis Reagent Strips provide tests for glucose, bilirubin, ketone, specific gravity, blood, pH, protein, urobilinogen, nitrite and leucocytes in urine.
Not Found
The document provided is a 510(k) clearance letter from the FDA for "Urinalysis Reagent Strips (10 Parameters)". This type of document assesses substantial equivalence to a predicate device, rather than detailed performance reports or clinical study results as would be found in a Premarket Approval (PMA) application. Therefore, the information requested about acceptance criteria, study details, and ground truth establishment is not available in this document.
The primary function of a 510(k) notification is to demonstrate that the new device is as safe and effective as a legally marketed predicate device. This typically involves submitting information on design, materials, chemical composition, energy source, manufacturing process, and intended use, along with performance data demonstrating equivalence to the predicate device. However, the FDA letter itself does not contain the detailed performance data or study methodology that would typically be included in a scientific study report.
Here's a breakdown of why each requested piece of information cannot be provided based on the given text:
- 1. A table of acceptance criteria and the reported device performance: This document is the FDA's clearance letter, not the study report itself. It states that the device is "substantially equivalent" but does not provide specific performance metrics or acceptance criteria tables.
- 2. Sample size used for the test set and the data provenance: Not present in this regulatory clearance letter. The original 510(k) submission would have contained this information.
- 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not present.
- 4. Adjudication method for the test set: Not present.
- 5. If a multi reader multi case (MRMC) comparative effectiveness study was done: Not applicable for a device like urinalysis reagent strips, which are not typically "read" by multiple human readers in the same way as, for example, medical images for diagnosis. Even if a comparative study was done to demonstrate equivalence to the predicate device, details are not in this letter.
- 6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. These are reagent strips that produce a visual color change interpreted by a human, not an algorithm.
- 7. The type of ground truth used: Not present. For a diagnostic device like reagent strips, ground truth would likely involve more definitive laboratory methods (e.g., standard chemical analysis) to confirm the presence and concentration of the analytes.
- 8. The sample size for the training set: Not present.
- 9. How the ground truth for the training set was established: Not present.
To obtain the detailed study information, one would typically need to refer to the original 510(k) submission documentation filed with the FDA, which is a much more extensive technical package than the clearance letter provided.
§ 862.1510 Nitrite (nonquantitative) test system.
(a)
Identification. A nitrite (nonquantitative) test system is a device intended to identify nitrite in urine. Nitrite identification is used in the diagnosis and treatment of uninary tract infection of bacterial origin.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 862.9.