(276 days)
The N-Assay TIA Apoprotein A-l Test Kit is intended to be used for the quantitative determination of human apoprotein a successor and in numan serum by immunoturòid assay. The measurement in numan serum by immunoturòid assay. The measurement in numan serum by immondtoldimetric assay. The meadershow. of apoprotein A-l is useful in the diagnosis of atherosclerosis.
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The provided text is a 510(k) clearance letter from the FDA for the N-Assay TIA Apolipoprotein A-1 Test Kit. It states that the device is substantially equivalent to legally marketed predicate devices. However, this document does not contain information about acceptance criteria, device performance studies, sample sizes, expert qualifications, or ground truth establishment relevant to the device's accuracy or effectiveness.
Therefore, I cannot fulfill your request for the specific details about acceptance criteria and the study proving the device meets them based on the provided input.
The document mainly focuses on the regulatory aspects of the device's clearance for marketing.
§ 866.5580
Alpha -1-lipoprotein immunological test system.(a)
Identification. Analpha -1-lipoprotein immunological test system is a device that consists of the reagents used to measure by immunochemical techniques thealpha- 1-lipoprotein (high-density lipoprotein) in serum and plasma. Measurement ofalpha- 1-lipoprotein may aid in the diagnosis of Tangier disease (a hereditary disorder of fat metabolism).(b)
Classification. Class II (performance standards).