# K992665: Macra LP (a) Enzyme Immunoassay Kit

- Pathway: 510(k) (Traditional)
- Applicant: Trinity Biotech USA
- Decided: Nov 26, 1999 after 109 days
- Product code: DFC (Lipoprotein, Low-Density, Antigen, Antiserum, Control)
- Device class: 2
- Regulation: 21 CFR 866.5600
- 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. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K013130: N LP (a) Control SY (2001), 0 descendants of its own

## Indications for use
The Macra® Lp(a) Enzyme Linked Immunosorbant Assay (ELISA) kit, is an in vitro diagnostic device for the quantitative measurement of Lp(a), in human serum or plasma, for the assessment of risk for coronary heart disease (CHD) in specific populations, along with other risk factors.

Source page: https://510kreport.com/device/K992665
Methodology: https://510kreport.com/methodology