# K062234: Modification to Diadexus Plac Test

- Pathway: 510(k) (Special)
- Applicant: Diadexus, Inc.
- Decided: Sep 11, 2006 after 40 days
- Product code: NOE (Test, System, Immunoassay, Lipoprotein-Associated Phospholipase A2)
- Device class: 2
- Regulation: 21 CFR 866.5600
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K050523 (2005). 1 ancestor in all.
2 later devices descend from it; 2 cite 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)
- K050523: Diadexus Plac Test, Diadexus, Inc. (2005) Summary page 3.

## Most influential descendants
- 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

## Recalls of this device
- Aug 20, 2010 · Not classified · Z-1737-2011: Product fails stability tests prior to expiration date.

## Indications for use
The diaDexus PLAC® test is an enzyme immunoassay for the quantitative determination of Lp-PLA 2 (lipoprotein-associated phospholipase A 2) in human plasma and serum, 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/K062234
Methodology: https://510kreport.com/methodology