(47 days)
This product is to be used in a diagnostic laboratory setting, by qualified laboratory technologists, for the quantitative determination of low density lipoprotein (LDL) cholesterol in serum or plasma. LDL cholesterol is a key factor in the pathogenesis of atherosclerosis and coronary artery disease. An increase in LDL cholestrerol can occur with an associated risk for coronary artery disease even within a normal total cholesterol concentration. This reagent set is intended for in vitro diagnostic use only.
autoLDL Cholesterol Reagent Set
The provided text is a cover letter from the FDA to Point Scientific, Inc. regarding their autoLDL Cholesterol Reagent Set and Calibrator. It states that the device has been found substantially equivalent to predicate devices and can be marketed.
However, this document does not contain any information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert qualifications as requested.
Therefore, I cannot provide the requested table and information. The document merely confirms the device's market clearance based on substantial equivalence, without detailing the specific data that led to that determination.
§ 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.