# K072599: Plac Test Reagent Kit,Calibrator Kit, LP-PLA2 Control Kit, Model (S) 90107,90109,90109

- Pathway: 510(k) (Traditional)
- Applicant: Diadexus, Inc.
- Decided: Dec 20, 2007 after 97 days
- Product code: NOE (Test, System, Immunoassay, Lipoprotein-Associated Phospholipase A2)
- Device class: 2
- Regulation: 21 CFR 866.5600
- Recalls of this device: 7 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K050523 (2005). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K062234: Modification to Diadexus Plac Test, Diadexus, Inc. (2006) Summary page 2.

## Recalls of this device
- Oct 29, 2009 · Not classified · Z-1749-2010: Inaccurate results-- some samples may return with falsely elevated results potentially as a result of an interfering substance. Some patients may be subjected to additional lifestyle changes or intens
- Oct 29, 2009 · Not classified · Z-1752-2010: Inaccurate results-- some samples may return with falsely elevated results potentially as a result of an interfering substance. Some patients may be subjected to additional lifestyle changes or intens
- Oct 29, 2009 · Not classified · Z-1753-2010: Inaccurate results-- some samples may return with falsely elevated results potentially as a result of an interfering substance. Some patients may be subjected to additional lifestyle changes or intens
- Oct 29, 2009 · Not classified · Z-1750-2010: Inaccurate results-- some samples may return with falsely elevated results potentially as a result of an interfering substance. Some patients may be subjected to additional lifestyle changes or intens
- Oct 29, 2009 · Not classified · Z-1748-2010: Inaccurate results-- some samples may return with falsely elevated results potentially as a result of an interfering substance. Some patients may be subjected to additional lifestyle changes or intens
- Oct 29, 2009 · Not classified · Z-1751-2010: Inaccurate results-- some samples may return with falsely elevated results potentially as a result of an interfering substance. Some patients may be subjected to additional lifestyle changes or intens
- Feb 9, 2009 · Not classified · Z-1205-2009: Premature Expiration-- the product is projected to fall short of expected shelf life, and may result in inaccurate results.

## Indications for use
The PLAC® Test Reagent Kit is a turbidimetric immunoassay for the quantitative determination of Lp-PLA 2 (lipoprotein-associated phospholipase A 2) in human plasma or serum on automated clinical chemistry analyzers, 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. The PLAC® Test Calibrator Kit is intended to establish points of reference that are used in the determination of values in the measurement of Lp-PLA 2 by the PLAC® Test Reagent Kit. The Lp-PLA 2 Control Kit is intended for use as a quality control tool to monitor the performance within the clinical range of the PLAC® Test Reagent Kit, a turbidimetric immunoassay for the quantitative determination of Lp-PLA 2.

Source page: https://510kreport.com/device/K072599
Methodology: https://510kreport.com/methodology