(315 days)
These products are to be used for the quantitative determination of apolipoprotein A1 and apolipoprotein B in human serum by immunoturbidimetric analysis. The determination of apolipoprotein A1 and apolipoprotein B are commonly performed as an aid in the assessment of individuals who are at risk for developing coronary artery disease.
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The provided text is a clearance letter from the FDA for an in vitro diagnostic device, specifically for Apolipoprotein A1 and Apolipoprotein B reagents and calibrators. This document is a regulatory approval and does not contain the information requested regarding acceptance criteria, study details, sample sizes, ground truth establishment, or expert qualifications for a device performance study.
The letter states that the device is substantially equivalent to legally marketed predicate devices and outlines general regulatory compliance requirements. It does not include data from a specific performance study.
Therefore, I cannot fulfill your request using the provided text. To answer your questions, I would need a document detailing the actual performance study conducted for the device's clearance.
§ 862.1475 Lipoprotein test system.
(a)
Identification. A lipoprotein test system is a device intended to measure lipoprotein in serum and plasma. Lipoprotein measurements are used in the diagnosis and treatment of lipid disorders (such as diabetes mellitus), atherosclerosis, and various liver and renal diseases.(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.