# K971162: Liquid N-Geneous HDL Cholesterol Kit/Calibrator

- Pathway: 510(k) (Traditional)
- Applicant: Genzyme Corp.
- Decided: Jun 16, 1997 after 77 days
- Product code: LBS (Ldl & Vldl Precipitation, Cholesterol Via Esterase-Oxidase, 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.
5 later devices descend from it; 1 cites it directly.
0 of 6 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) Sodium Phosphotungstate MgCl₂ (PTA) method: named in the summary without a submission number
- (no number) CDC Designated Comparison Method: named in the summary without a submission number

## Most influential descendants
- K063841: NMR Profiler and NMR Lipoprofile Assay, Controls (2008), 4 descendants of its own
- K111516: NMR Lipoprofile (R) Test and NMR Profiler (2011), 2 descendants of its own
- K113830: Vantera Clinical Analyzer (2012), 1 descendant of its own
- K210801: AXINON® LDL-p Test System (2023), 0 descendants of its own
- K133849: Vantera Clinical Analyzer (2014), 0 descendants of its own

## Indications for use
For the quantitative determination of high-density lipoprotein Cholesterol (HDL-C) in human serum and plasma. For the calibration of the Liquid N-geneous HDL Cholesterol assay.

Source page: https://510kreport.com/device/K971162
Methodology: https://510kreport.com/methodology