# K971573: N-Geneous LDL Cholesterol Reagent, N-Geneous LDL Cholesterol Calibrator, Genzyme LDL Cholesterol Control Set

- Pathway: 510(k) (Traditional)
- Applicant: Genzyme Corp.
- Decided: Jun 18, 1997 after 49 days
- Product code: LBR (Ldl & Vldl Precipitation, Hdl)
- 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.
21 later devices descend from it; 7 cite it directly.
0 of 22 devices 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) Direct LDL Cholesterol Immunoseparation Reagent: named in the summary without a submission number
- (no number) B-Quantification methods: named in the summary without a submission number

## Most influential descendants
- K020724: Dimension Automated LDL Cholesterol Flex Reagentcartridge Method, Model DF131 (2002), 8 descendants of its own
- K063841: NMR Profiler and NMR Lipoprofile Assay, Controls (2008), 4 descendants of its own
- K991733: Ace LDL-C Reagent, LDL-C Calibrator, LDL-C Controls (1999), 4 descendants of its own
- K060854: Abx Pentra 400:  Lipoproteins (2006), 3 descendants of its own
- K111516: NMR Lipoprofile (R) Test and NMR Profiler (2011), 2 descendants of its own

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

Source page: https://510kreport.com/device/K971573
Methodology: https://510kreport.com/methodology