# K203136: Diazyme PLAC® Test for Lp-PLA2 Activity

- Pathway: 510(k) (Special)
- Applicant: Diazyme Laboratories, Inc.
- Decided: Aug 6, 2021 after 290 days
- Product code: NOE (Test, System, Immunoassay, Lipoprotein-Associated Phospholipase A2)
- 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.
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 Diazyme PLAC® Test for Lp-PLA2 Activity is an enzyme assay for the in vitro quantitative determination of Lp-PLAZ2 (lipoprotein-associated phospholipase A2) activity in EDTA plasma and serum on automated clinical chemistry analyzers. Lp-PLA2 activity is to be used in conjunction with clinical evaluation and patient risk assessment as an aid in predicting risk of coronary heart disease (CHD) in patients with no prior history of cardiovascular events.

Source page: https://510kreport.com/device/K203136
Methodology: https://510kreport.com/methodology