(77 days)
for the quantitative determination of high density lipoprotein (HDL) cholesterol in human serum or plasma. For in vitro diagnostic use. For the calibration of N-geneous HDL Cholesterol ass in serum or plasma. For in vitro diagnostic use.
The Genzyme N-geneous™ HDL Cholesterol Kit is an in vitro diagnostic product cleared (FDA Reference No. K962186) for use in the clinical laboratory for the quantitative determination of high density lipoprotein cholesterol in human serum or plasma. The first reagent contains a mixture of polymers and polyanions that bind to the surface of low-density lipoproteins (LDL), very low-density lipoproteins (VLDL) and chylomicrons. These complexed lipoproteins are stabilized, even in the presence of detergent which is added as part of the second reagent, together with the remaining components of a cholesterol reagent. HDL particles, on the other hand, are not stabilized by the polymers and polyanions and become solubilized by the detergent. Consequently, only the HDL cholesterol is subject to cholesterol measurement.
Here's a breakdown of the acceptance criteria and study information for the Genzyme N-geneous™ HDL Cholesterol Reagent Kit, based on the provided 510(k) Premarket Notification:
Acceptance Criteria and Reported Device Performance
The acceptance criteria are implicitly defined by the NCEP (National Cholesterol Education Program) goals for precision. No explicit numerical targets for correlation coefficients are provided, but the reported values demonstrate substantial equivalence.
| Acceptance Criteria (NCEP Goals for POL sites using N-geneous™ Kit) | Reported Device Performance (N-geneous™ Kit in POL) |
|---|---|
| CVs ≤6% at ≥42 mg/dL HDL cholesterol | Achieved ≤6% |
| SD ≤2.5 mg/dL at |
§ 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.