# K021316: Ultra N-Geneous HDL Cholesterol Reagent 1/REAGENT2; Ultra N-Geneous HDL Cholestreol Calibrator

- Pathway: 510(k) (Traditional)
- Applicant: Genzyme Corp.
- Decided: Jul 25, 2002 after 91 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.
9 later devices descend from it; 7 cite it directly.
0 of 10 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) Liquid N-geneous HDL Cholesterol Reagent method: named in the summary without a submission number

## Most influential descendants
- K060854: Abx Pentra 400:  Lipoproteins (2006), 3 descendants of its own
- K241800: Atellica® CH HDL Cholesterol (HDLC)& Atellica® CH LDL Cholesterol (LDLC) (2024), 0 descendants of its own
- K162593: HDL-Cholesterol Gen.4 (2016), 0 descendants of its own
- K103747: Elitech Clincal Systems Cholesterol HDL SL 2G, HDL 2G Calibrator, LDL SL 2G, LDL 2G Calibrator, Elitrol II & Elitech Sys (2011), 0 descendants of its own
- K102993: Elitech Clinical Systems Triglycerides SL, Elitech Clinical Systems Cholesterol SL (2011), 0 descendants of its own

## Indications for use
Reagent: For the quantitative determination of high-density cholesterol lipoprotein cholesterol in human serum or plasma. Lipoprotein measurements are used in the diagnosis and treatment of lipid disorders (such as diabetes mellitus, atherosclerosis and various liver and renal diseases). Calibrator: For calibration of the Ultra HDL Cholesterol assay.

Source page: https://510kreport.com/device/K021316
Methodology: https://510kreport.com/methodology