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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Super Search Devices@FDA
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Device prostate-specific antigen (psa) for management of prostate cancers
Regulation Description Tumor-associated antigen immunological test system.
Product CodeLTJ
Regulation Number 866.6010
Device Class 2


Premarket Reviews
ManufacturerDecision
BAYER
  SUBSTANTIALLY EQUIVALENT 4
BIOMERIEUX
  SUBSTANTIALLY EQUIVALENT 1
BOEHRINGER
  SUBSTANTIALLY EQUIVALENT 5
DADE BEHRING
  SUBSTANTIALLY EQUIVALENT 2
DIAGNOSTIC PRODUCTS
  SUBSTANTIALLY EQUIVALENT 3
Nichols Institute Diagnostics
  SUBSTANTIALLY EQUIVALENT 1
ORTHO-CLINICAL
  SUBSTANTIALLY EQUIVALENT 2

Premarket Approvals (PMA)
2007 2008 2009 2010 2011 2012 2013 2014 2015 2016
0 0 0 0 0 0 0 0 0 1

Device Problems
Low test results 42
High test results 33
Incorrect or inadequate test results 32
Incorrect or inadequate result 11
Incorrect measurement 2
High Readings 1
Low readings 1
Total Device Problems 122

Recalls
  2007 2008 2009 2010 2011 2012 2013 2014 2015 2016
Class I 0 0 0 0 0 0 0 0 0 0
Class II 0 2 1 0 1 0 1 0 0 0
Class III 0 0 0 0 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Beckman Coulter Inc II Apr-28-2009
2 BioCheck Inc II Mar-11-2011
3 Qualigen Inc II Dec-19-2013
4 Qualigen Inc II Dec-22-2008
5 Siemens Medical Solutions Diagnostics II Sep-16-2008

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