# K971526: Ace HDL-C Reagent

- Pathway: 510(k) (Traditional)
- Applicant: Schiapparelli Biosystems, Inc.
- Decided: May 21, 1997 after 23 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
Longest line of descent: 1 generation back to K962186 (1996). 1 ancestor in all.
3 later devices descend from it; 2 cite it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K962186: N-Geneous HDL Cholesterol Kit/Cholesterol Calibrator, Genzyme Corp. (1996) Summary page 1.

## Most influential descendants
- K113262: Ace Cholesterol Reagent, Ace HDL-C Reagent, Ace LDL-C Reagent-C, Ace-Trislycerides Reagent (2012), 1 descendant of its own
- K122757: Ace Cholesterol Reagent, Ace HDL-C Reagent, Ace LDL-C Reagent, Ace Triglycerides Reagent (2012), 0 descendants of its own
- K112538: Ace Cholesterol Reagent, Ace HDL-C Reagent, Ace LDL-C Reagent, Ace Triglycerides Reagent (2012), 0 descendants of its own

## Indications for use
This in vitro diagnostic product is intended for the quantitative determination of HDL cholesterol in human serum. Numerous studies have shown an inverse relationship between serum HDL cholesterol and the risk of coronary heart disease. HDL cholesterol also has an important role in the pathogenesis of atherosclerosis.

Source page: https://510kreport.com/device/K971526
Methodology: https://510kreport.com/methodology