# K981224: Direct HDL

- Pathway: 510(k) (Traditional)
- Applicant: Abbott Laboratories
- Decided: Aug 3, 1998 after 122 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.
1 later device descends from it; 1 cites it directly.
0 of 2 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) Boehringer Mannheim Direct HDL assay on the Hitachi 717 Analyzer: named in the summary without a submission number

## Most influential descendants
- K232404: CHOLESTEROL; HDL-cholesterol ; LDL-cholesterol; TRIGLYCERIDES (2024), 0 descendants of its own

## 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/K981224
Methodology: https://510kreport.com/methodology