# K971157: Macralp (a) Enzyme Immunoassay Kit

- Pathway: 510(k) (Traditional)
- Applicant: Strategic Diagnostics, Inc.
- Decided: Apr 15, 1998 after 383 days
- Product code: JHO (Electrophoretic Separation, Lipoproteins)
- 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.
No later device cites it as a predicate yet.
0 of 1 device 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.

## Indications for use
The Macra® Lp(a) enzyme immunoassay device 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. It is not intended to be used as a sole determinant of risk, but should be used in conjunction with other risk factors.

Source page: https://510kreport.com/device/K971157
Methodology: https://510kreport.com/methodology