# K992766: N-Geneous LDL-ST Cholesterol Reagent, N-Geneous LDL-ST Cholesterol Calibrator, Genzyme LDL Cholesterol Control Set

- Pathway: 510(k) (Traditional)
- Applicant: Genzyme Corp.
- Decided: Oct 18, 1999 after 62 days
- Product code: MRR (System, Test, Low Density, Lipoprotein)
- Device class: 1
- Regulation: 21 CFR 862.1475
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) N-geneous® LDL Cholesterol Reagents: named in the summary without a submission number
- (no number) B-Quantification methods: named in the summary without a submission number

## Indications for use
Reagents: For the direct, quantitative determination of low-density lipoprotein cholesterol (LDL-C) in human serum or plasma. Calibrator: For the calibration of the N-geneous® LDL-ST Cholesterol assay in serum or plasma. Controls: To monitor the performance of the Genzyme Direct LDL Cholesterol, N-geneous® LDL Cholesterol and N-geneous® LDL-ST Cholesterol Reagents.

Source page: https://510kreport.com/device/K992766
Methodology: https://510kreport.com/methodology