(43 days)
The Uric Acid reagent, product No. UA112-01 is intended for Invitro Diagnostic use in the automated, quantitative determination of Uric Acis in serum, or plasma.
Not Found
The provided text is a 510(k) clearance letter from the FDA for a Uric Acid reagent. It primarily focuses on the regulatory approval and substantial equivalence to a predicate device. It does not contain information typically found in a study report, such as:
- Specific acceptance criteria and reported device performance: The letter states the device is "substantially equivalent" but provides no performance metrics or criteria.
- Sample size and data provenance for a test set.
- Number and qualifications of experts for ground truth establishment.
- Adjudication method.
- Result of a multi-reader multi-case (MRMC) comparative effectiveness study.
- Standalone algorithm performance.
- Type of ground truth used.
- Training set sample size.
- Method for establishing training set ground truth.
Therefore, I cannot extract the requested information from the provided document as it does not contain the details of a performance study.
§ 862.1775 Uric acid test system.
(a)
Identification. A uric acid test system is a device intended to measure uric acid in serum, plasma, and urine. Measurements obtained by this device are used in the diagnosis and treatment of numerous renal and metabolic disorders, including renal failure, gout, leukemia, psoriasis, starvation or other wasting conditions, and of patients receiving cytotoxic drugs.(b)
Classification. Class I (general controls). The device, when it is solely intended for use as an acid reduction of ferric ion test, a phosphotungstate reduction test, a gasometric uricase test, an ultraviolet uricase test, or an oxygen rate uricase test, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.