# K030477: Diadexus Plac Test

- Pathway: 510(k) (Traditional)
- Applicant: Diadexus, Inc.
- Decided: Jul 18, 2003 after 155 days
- Product code: NOE (Test, System, Immunoassay, Lipoprotein-Associated Phospholipase A2)
- Device class: 2
- Regulation: 21 CFR 866.5600
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K000121 (2000). 2 ancestors in all.
4 later devices descend from it; 2 cite it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K013128: N Latex LP (a), Dade Behring, Inc. (2002)

## Most influential descendants
- K050029: Cardiompo Test (2005), 2 descendants of its own
- K141575: Plac Test for LP-PLA2 Activity (2014), 0 descendants of its own
- K071474: Dimension Clinical Chemistry System Mpo Flex Reagent Cartridge, Calibrator,Control, Model RF425, RC425,RC426 (2008), 0 descendants of its own
- K062840: Triage Protein C Controls and Calibration Verification Controls (2007), 0 descendants of its own

## Recalls of this device
- Jul 18, 2008 · Not classified · Z-2399-2008: Product may give Lp-PLA2 values at up to 22% lower than accurate values.
- Jul 18, 2008 · Not classified · Z-2400-2008: Product may give Lp-PLA2 values at up to 22% lower than accurate values.

## Indications for use
The diaDexus PLACTMtest 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.

Source page: https://510kreport.com/device/K030477
Methodology: https://510kreport.com/methodology