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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device enzyme immunoassay, cocaine and cocaine metabolites
Regulation Description Cocaine and cocaine metabolite test system.
Product CodeDIO
Regulation Number 862.3250
Device Class 2


Premarket Reviews
ManufacturerDecision
ABBOTT
  SUBSTANTIALLY EQUIVALENT 6
BOEHRINGER
  SUBSTANTIALLY EQUIVALENT 1
DADE BEHRING
  SUBSTANTIALLY EQUIVALENT 4
DIAGNOSTIC PRODUCTS
  SUBSTANTIALLY EQUIVALENT 3
ORASURE TECHNOLOGIES, INC.
  SUBSTANTIALLY EQUIVALENT 4
ORTHO-CLINICAL
  SUBSTANTIALLY EQUIVALENT 1
PHAMATECH
  SUBSTANTIALLY EQUIVALENT 3
QUEST MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 2
ROCHE DIAGNOSTICS CORP.
  SUBSTANTIALLY EQUIVALENT 13

Device Problems
Incorrect or inadequate test results 5
No Known Device Problem 1
False positive result 1
Total Device Problems 7

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 0 0 3 2 0 0
Class III 0 0 0 0 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Branan Medical Corporation II Apr-24-2014
2 Medtox Diagnostics Inc II May-16-2013
3 Microgenics Corp II Sep-23-2013
4 Ortho-Clinical Diagnostics II Jan-23-2014
5 Sarken, Inc. II Aug-23-2013

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