510(k) K050523

DIADEXUS PLAC TEST by Diadexus, Inc. — Product Code NOE

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: June 15, 2005
Date Received: March 2, 2005
Clearance Type: Traditional
Expedited Review: No
Third Party Review: No

Device Classification

Device Name: Test, System, Immunoassay, Lipoprotein-Associated Phospholipase A2
Device Class: Class II
Regulation Number: 866.5600
Review Panel: IM
Submission Type

The Lipoprotein-associated Phospholipase A2, Immunoassay, System, Test, is intended to measure lipoprotein-associated phospholipase A2 in human plasma in conjunction with clinical evaluation and other patient risk factors including biochemical analyses as an aid in predicting risk for coronary heat disease. This device differs from the classification regulation in that it is a different analyte, thus a NEW marker for predicting risk of coronary heart disease. This device is measuring an enzyme that is produced by macrophages where as the regulation is for the measurement of a lipoprotein.

Other clearances by Diadexus, Inc.

K141575 — PLAC TEST FOR LP-PLA2 ACTIVITY (December 15, 2014)
K101853 — PLAC TEST REAGENT KIT, MODELS 90107, 90112, 90115, 90116, 10-0112, 10-0113, 10-0 (January 3, 2011)
K072599 — PLAC TEST REAGENT KIT,CALIBRATOR KIT, LP-PLA2 CONTROL KIT, MODEL(S) 90107,90109, (December 20, 2007)
K062234 — MODIFICATION TO DIADEXUS PLAC TEST (September 11, 2006)
K040101 — MODIFICATION TO DIADEXUS PLAC TEST (February 5, 2004)
K030477 — DIADEXUS PLAC TEST (July 18, 2003)

Other clearances for product code NOE

K203136 — Diazyme PLAC® Test for Lp-PLA2 Activity (August 6, 2021)
K141575 — PLAC TEST FOR LP-PLA2 ACTIVITY (December 15, 2014)
K101853 — PLAC TEST REAGENT KIT, MODELS 90107, 90112, 90115, 90116, 10-0112, 10-0113, 10-0 (January 3, 2011)
K072599 — PLAC TEST REAGENT KIT,CALIBRATOR KIT, LP-PLA2 CONTROL KIT, MODEL(S) 90107,90109, (December 20, 2007)
K062234 — MODIFICATION TO DIADEXUS PLAC TEST (September 11, 2006)
K040101 — MODIFICATION TO DIADEXUS PLAC TEST (February 5, 2004)
K030477 — DIADEXUS PLAC TEST (July 18, 2003)