# K981580: HDL

- Pathway: 510(k) (Traditional)
- Applicant: Abbott Laboratories
- Decided: Jun 11, 1998 after 38 days
- Product code: LBS (Ldl & Vldl Precipitation, Cholesterol Via Esterase-Oxidase, Hdl)
- Device class: 1
- Regulation: 21 CFR 862.1475
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K963213 (1996). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K963213: Boehringer Mannheim Direct HDL-Cholesterol, Boehringer Mannheim Corp. (1996) Summary page 2.

## Recalls of this device
- Mar 28, 2003 · Not classified · Z-0803-03: Degredation prior to expiry date.

## Indications for use
The Direct HDL assay is used for the quantitation of high-density lipoprotein cholesterol levels in human serum or plasma. Low Direct HDL measurements are used in the diagnosis and treatment of coronary artery disease.

Source page: https://510kreport.com/device/K981580
Methodology: https://510kreport.com/methodology