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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device system, test, human chorionic gonadotropin
Regulation Description Human chorionic gonadotropin (HCG) test system.
Product CodeDHA
Regulation Number 862.1155
Device Class 2


Premarket Reviews
ManufacturerDecision
ABBOTT
  SUBSTANTIALLY EQUIVALENT 2
BAXTER HEALTHCARE CORP.
  SUBSTANTIALLY EQUIVALENT 2
BAYER
  SUBSTANTIALLY EQUIVALENT 1
BOEHRINGER
  SUBSTANTIALLY EQUIVALENT 2
DADE BEHRING
  SUBSTANTIALLY EQUIVALENT 2
  SUBSTANTIALLY EQUIVALENT - CLIA SUBMISSION 1
DIAGNOSTIC PRODUCTS
  SUBSTANTIALLY EQUIVALENT 2
  SUBSTANTIALLY EQUIVALENT - CLIA SUBMISSION 1
Nichols Institute Diagnostics
  SUBSTANTIALLY EQUIVALENT - CLIA SUBMISSION 1
ORGANON-TEKNIKA
  SUBSTANTIALLY EQUIVALENT 1
ORTHO-CLINICAL
  SUBSTANTIALLY EQUIVALENT - CLIA SUBMISSION 1
ROCHE DIAGNOSTICS CORP.
  SUBSTANTIALLY EQUIVALENT 1
  SUBSTANTIALLY EQUIVALENT - CLIA SUBMISSION 1
WAMPOLE LABORATORIES,LLC
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Low test results 138
High test results 72
False positive result 65
Incorrect or inadequate test results 58
False negative result 29
Incorrect or inadequate result 17
Output, low 8
Imprecision 3
High Readings 1
Device displays error message 1
Output, high 1
Total Device Problems 393

Recalls
  2007 2008 2009 2010 2011 2012 2013
Class I 0 0 0 0 0 0 0
Class II 0 0 0 0 1 0 0
Class III 0 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 BioCheck Inc II Mar-11-2011

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