(53 days)
Intended for the In Vitro, quantitative determination of uric acid in human serum on automated chemistry analyzers.
Uric Acid measurements 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.
Not Found
I am sorry, but based on the provided document, the information requested in your prompt (acceptance criteria, study details, sample sizes, expert qualifications, etc.) is not available. This document is an FDA 510(k) clearance letter for a Uric Acid Reagent, which states that the device is substantially equivalent to legally marketed devices and can proceed to market. It does not contain details about specific acceptance criteria or a study proving that the device meets those criteria.
§ 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.