# K180074: Diazyme Lipoprotein (a) Assay

- Pathway: 510(k) (Traditional)
- Applicant: Diazyme Laboratories, Inc.
- Decided: Mar 22, 2018 after 71 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.
2 later devices descend from it; 2 cite it directly.
0 of 3 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
- K253069: Lipoprotein (a) Molarity Assay (2026), 0 descendants of its own
- K211058: Lp (a) Ultra (2022), 0 descendants of its own

## Indications for use
The Diazyme Lipoprotein (a) Assay is intended as a latex particle enhanced immunoturbidimetric assay for the in vitro quantitative determination of lipoprotein(a) [Lp(a)] concentration in human serum or plasma on Clinical Chemistry Systems. The measurement of Lipoprotein (a) is useful in evaluating lipid metabolism disorders and assessing atherosclerotic cardiovascular diseases in specific populations, when used in conjunction with clinical evaluation. For in vitro diagnostic use only.

Source page: https://510kreport.com/device/K180074
Methodology: https://510kreport.com/methodology