# K253069: Lipoprotein (a) Molarity Assay

- Pathway: 510(k) (Traditional)
- Applicant: Diazyme Laboratories, Inc.
- Decided: Jun 16, 2026 after 266 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 K180074 (2018). 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)
- K180074: Diazyme Lipoprotein (a) Assay, Diazyme Laboratories, Inc. (2018) Summary page 5.

## Indications for use
The Lipoprotein (a) Molarity Assay is intended as an in vitro test for quantitative determination of Lipoprotein(a) [Lp(a)] concentrations in human serum and plasma on validated automated analyzers. The measurement of Lp(a) is useful in evaluating lipid metabolism disorders and assessing atherosclerotic cardiovascular disease risk, when used in conjunction with clinical evaluation and other lipoprotein tests.

Source page: https://510kreport.com/device/K253069
Methodology: https://510kreport.com/methodology