Skip to content

Diadexus Plac Test

by Diadexus, Inc. 510(k)

Active United States

510(k) K030477

Overview

The DIADEXUS PLAC TEST is a widely used immunology diagnostic test, providing accurate results for lipoprotein-associated phospholipase A2 (Lp-PLA2) levels. This test is typically administered in a clinical setting and is suitable for use in laboratories, hospitals, or other medical facilities.

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK030477 Date18 Jul 2003ClearedStatusActive

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Recalls

2 recalls · FDA

  • 2 recalls, same reason

    • Terminated Z-2399-2008 FDA Unclassified (pre-2012) initiated 18 Jul 2008
    • Terminated Z-2400-2008 FDA Unclassified (pre-2012) initiated 18 Jul 2008

    Product may give Lp-PLA2 values at up to 22% lower than accurate values.

Specification

510(k)

510(k) Number
FDA Product Code
NOE
Device Class
Class II
Regulation
21 CFR Part 866.5600
Advisory Committee
Immunology
FDA Decision
SESE Substantially Equivalent

Other devices from Diadexus, Inc.