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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 139
High test results 76
False positive result 70
Incorrect or inadequate test results 59
False negative result 30
Incorrect or inadequate result 18
Output, low 8
Imprecision 3
No Known Device Problem 2
High Readings 1
Device displays error message 1
Mechanical issue 1
Device handling issue 1
Output, high 1
Total Device Problems 410

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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