(88 days)
Cholesterol measurements are used in the diagnosis and treatment of disorders involving excess cholesterol in the blood and lipid and lipoprotein metabolism disorders.
CHOLESTEROL REAGENT
The provided text is a 510(k) clearance letter from the FDA for a device named "CHOLESTEROL REAGENT." This document is a regulatory approval and does not contain any information regarding acceptance criteria or a study proving the device meets acceptance criteria.
The letter states that the device is "substantially equivalent" to predicate devices, which means it has been compared to a device already legally marketed. However, it does not describe the specific performance characteristics, clinical study design, or results that would be expected in a document outlining acceptance criteria and a study to meet them.
Therefore, I cannot provide the requested information based on the input text.
§ 862.1175 Cholesterol (total) test system.
(a)
Identification. A cholesterol (total) test system is a device intended to measure cholesterol in plasma and serum. Cholesterol measurements are used in the diagnosis and treatment of disorders involving excess cholesterol in the blood and lipid and lipoprotein metabolism disorders.(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.