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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 3
BAXTER HEALTHCARE CORP.
  SUBSTANTIALLY EQUIVALENT 2
BAYER
  SUBSTANTIALLY EQUIVALENT 1
BECKMAN COULTER
  SUBSTANTIALLY EQUIVALENT 1
BOEHRINGER
  SUBSTANTIALLY EQUIVALENT 2
DADE BEHRING
  SUBSTANTIALLY EQUIVALENT 3
DIAGNOSTIC PRODUCTS
  SUBSTANTIALLY EQUIVALENT 3
DIASORIN
  SUBSTANTIALLY EQUIVALENT 1
Nichols Institute Diagnostics
  SUBSTANTIALLY EQUIVALENT 1
ORGANON-TEKNIKA
  SUBSTANTIALLY EQUIVALENT 1
ORTHO-CLINICAL
  SUBSTANTIALLY EQUIVALENT 1
ROCHE DIAGNOSTICS CORP.
  SUBSTANTIALLY EQUIVALENT 2
WAMPOLE LABORATORIES,LLC
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Low test results 153
High test results 85
False positive result 70
Incorrect or inadequate test results 60
False negative result 30
Incorrect or inadequate result 19
Output, low 8
No Known Device Problem 5
Imprecision 3
Mechanical issue 1
Output, high 1
Device handling issue 1
High Readings 1
Device displays error message 1
Device operates differently than expected 1
Total Device Problems 439

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 0 0 0 1 0 0 0 0 2
Class III 0 0 0 0 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 BioCheck Inc II Mar-11-2011
2 Ortho-Clinical Diagnostics II May-20-2016
3 Siemens Healthcare Diagnostics Inc II Jan-07-2016

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