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510(k) K141575

PLAC TEST FOR LP-PLA2 ACTIVITY by Diadexus, Inc. — Product Code NOE

K141575 is an FDA 510(k) premarket notification submitted by Diadexus, Inc. for the device "PLAC TEST FOR LP-PLA2 ACTIVITY". The FDA issued a decision of Substantially Equivalent on December 15, 2014. The device falls under product code NOE (Test, System, Immunoassay, Lipoprotein-Associated Phospholipase A2), a Class II device regulated under 21 CFR 866.5600. Diadexus, Inc. has at least 6 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 15, 2014
Date Received
June 12, 2014
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.

  • 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)
  • K050523 — DIADEXUS PLAC TEST (June 15, 2005)
  • 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)
  • 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)
  • K050523 — DIADEXUS PLAC TEST (June 15, 2005)
  • K040101 — MODIFICATION TO DIADEXUS PLAC TEST (February 5, 2004)
  • K030477 — DIADEXUS PLAC TEST (July 18, 2003)

FDA data resources