(38 days)
The Randox Liquid Direct HDL-Cholesterol (HDL-C) test kit is an in vitro diagnostic reagent for the quantitative determination of HDL-Cholesterol in human serum and plasma. Accurate measurement of HDL-C is of importance when assessing patient risk from coronary heart disease.
In this diagnostic test kit a method for direct measurement of HDL-C, without sample pretreatment is presented.
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I am sorry, but the provided text does not contain the detailed information necessary to answer your request about acceptance criteria and the study that proves the device meets them. The document is a 510(k) clearance letter from the FDA for a "Direct HDL Cholesterol" device, informing the manufacturer that their device is substantially equivalent to legally marketed predicate devices.
The letter discusses regulatory classifications, general controls, and compliance requirements, but it does not include:
- A table of acceptance criteria and reported device performance.
- Information about sample sizes, data provenance, number or qualifications of experts, or adjudication methods for ground truth establishment.
- Details about multi-reader multi-case (MRMC) studies or standalone algorithm performance.
- The type of ground truth used.
- Sample size for the training set or how its ground truth was established.
This document is a regulatory approval notice, not a scientific study report or performance evaluation.
§ 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.