(241 days)
The ARCHITECT 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.
The Uric Acid assay is an in vitro diagnostic assay for use on the ARCHITECT c8000 System for the quantitative determination of uric acid in human serum, plasma, or urine using a uricase methodology. The Uric Acid assay is a two-part reaction. Uric acid is oxidized to allantoin by uricase with the production of hydrogen peroxide (H2O2). The H2O2 reacts with 4-aminoantipyrine (4-AAP) and N-(3-sulfopropyl)-3-methoxy-5methylanaline (HMMPS) in the presence of peroxidase (POD) to yield a quinoneimine dye. The resulting change in absorbance at 604 nm is proportional to the uric acid concentration in the sample.
The two-part (R1/R2) configuration of this assay allows reduction of interference from ascorbic acid by inclusion of ascorbic oxidase in the R1 portion of the assay.
The provided text describes a medical device, the Architect Uric Acid assay, which is used for the quantitative determination of uric acid in human serum, plasma, or urine. The information focuses on its intended use, technological characteristics, and substantial equivalence to a previously marketed device (Abbott On-Market Uric Acid assay).
However, the provided text does not contain the specific details required to complete your request, such as a table of acceptance criteria, reported performance, sample sizes for test and training sets, expert qualifications for ground truth, adjudication methods, or results of MRMC or standalone studies.
The text emphasizes that the new device is "substantially equivalent" to the predicate device, implying that its performance is expected to be similar, but it does not present the specific acceptance criteria or the study data proving that it meets those criteria. The FDA letter confirms the device's substantial equivalence but also does not include the detailed performance data.
Therefore, I cannot fully answer your request based on the provided input.
If such information were available in the text, it would typically appear in a section detailing specific performance studies (e.g., precision, accuracy, linearity, interference studies) and their results, often compared against predefined acceptance limits.
§ 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.