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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device test, system, immunoassay, lipoprotein-associated phospholipase a2
Definition 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.
Product CodeNOE
Regulation Number 866.5600
Device Class 2


Premarket Reviews
ManufacturerDecision
DIADEXUS, INC.
  SUBSTANTIALLY EQUIVALENT 2
DIAZYME LABORATORIES INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2015 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Incorrect, Inadequate or Imprecise Result or Readings 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Information 1 1

Recalls
Manufacturer Recall Class Date Posted
1 DiaDexus, Inc II Mar-21-2011
2 DiaDexus, Inc II Nov-22-2010
3 DiaDexus, Inc II Jun-03-2010
4 DiaDexus, Inc II Apr-23-2009
5 DiaDexus, Inc II Apr-01-2009
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