# K050523: Diadexus Plac Test

- Pathway: 510(k) (Traditional)
- Applicant: Diadexus, Inc.
- Decided: Jun 15, 2005 after 105 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.
3 later devices descend from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names no predicate by number.

## Most influential descendants
- K062234: Modification to Diadexus Plac Test (2006), 2 descendants of its own
- K101853: Plac Test Reagent Kit, Models 90107, 90112, 90115, 90116, 10-0112, 10-0113, 10-0115 (2011), 0 descendants of its own
- K072599: Plac Test Reagent Kit,Calibrator Kit, LP-PLA2 Control Kit, Model (S) 90107,90109,90109 (2007), 0 descendants of its own

## Indications for use
The diaDexus PLACTM test is an enzyme immunoassay for the quantitative determination of Lp-PLA2 (lipoprotein-associated phospholipase A2) in human plasma, to be used in conjunction with clinical evaluation and patient risk assessment as an aid in predicting risk for coronary heart disease and ischemic stroke associated with atherosclerosis.

Source page: https://510kreport.com/device/K050523
Methodology: https://510kreport.com/methodology