# K970302: Apo-Tek LP (a)

- Pathway: 510(k) (Traditional)
- Applicant: Perimmune, Inc.
- Decided: Nov 10, 1997 after 287 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
Longest line of descent: 1 generation back to K870564 (1987). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K910552: Roche Reagent for Apolipoprotein B, Roche Diagnostic Systems, Inc. (1991) Summary page 1.
- K870564: SPQ (TM) Test System for Apolipoprotein B, Atlantic Antibodies (1987) Summary page 1.

## Indications for use
Apo-Tek Lp(a)™ is an Apo(a) isoform independent enzyme-linked immunosorbent assay (ELISA) for the quantitative determination of lipoprotein(a) [Lp(a)] in human serum and plasma. The measurement of Lp(a), in conjunction with other lipoprotein tests, is of diagnostic significance when assessing atherosclerotic cardiovascular disease in specific populations.

Source page: https://510kreport.com/device/K970302
Methodology: https://510kreport.com/methodology