# K051962: Ultra HDL

- Pathway: 510(k) (Traditional)
- Applicant: Abbott Laboratories
- Decided: Aug 25, 2005 after 37 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 K021316 (2002). 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)
- K021316: Ultra N-Geneous HDL Cholesterol Reagent 1/REAGENT2; Ultra N-Geneous HDL Cholestreol Calibrator, Genzyme Corp. (2002) Summary page 2.

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

Source page: https://510kreport.com/device/K051962
Methodology: https://510kreport.com/methodology