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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device enzyme immunoassay, amphetamine
Regulation Description Amphetamine test system.
Product CodeDKZ
Regulation Number 862.3100
Device Class 2


Premarket Reviews
ManufacturerDecision
  SUBSTANTIALLY EQUIVALENT 1
ABBOTT
  SUBSTANTIALLY EQUIVALENT 8
BECKMAN COULTER
  SUBSTANTIALLY EQUIVALENT 1
DADE BEHRING
  SUBSTANTIALLY EQUIVALENT 5
DIAGNOSTIC PRODUCTS
  SUBSTANTIALLY EQUIVALENT 5
INSTRUMENTATION LABORATORY
  SUBSTANTIALLY EQUIVALENT 1
ORASURE TECHNOLOGIES, INC.
  SUBSTANTIALLY EQUIVALENT 2
ORTHO-CLINICAL
  SUBSTANTIALLY EQUIVALENT 1
PHAMATECH
  SUBSTANTIALLY EQUIVALENT 4
QUEST MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
ROCHE DIAGNOSTICS CORP.
  SUBSTANTIALLY EQUIVALENT 27

Device Problems
Device displays error message 12
Incorrect or inadequate result 5
Computer software issue 4
False positive result 3
No Known Device Problem 1
False negative result 1
Incorrect or inadequate test results 1
Total Device Problems 27

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 1 1 2 0 3 1 1 2 0 0
Class III 0 1 0 0 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Abbott Laboratories III May-14-2008
2 Alere San Diego II Jan-11-2012
3 Alere San Diego II Jul-27-2011
4 Alere San Diego, Inc. II Jan-09-2014
5 Ameditech Inc II Oct-16-2014
6 Ameditech Inc II Nov-03-2011
7 Ameditech Inc II Jun-27-2011
8 Bio-Rad Laboratories Inc II Apr-10-2007
9 Biosite Inc II Oct-06-2009
10 Biosite Inc II Mar-17-2009
11 Medtox Diagnostics Inc II Sep-26-2008
12 Sarken, Inc. II Aug-23-2013

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