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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device glucose oxidase, glucose
Regulation Description Glucose test system.
Product CodeCGA
Regulation Number 862.1345
Device Class 2


Premarket Reviews
ManufacturerDecision
ABBOTT
  SUBSTANTIALLY EQUIVALENT 14
  SUBSTANTIALLY EQUIVALENT - CLIA SUBMISSION 1
AMIRA MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 2
ARKRAY USA, INC.
  SUBSTANTIALLY EQUIVALENT - CLIA SUBMISSION 1
BAYER
  SUBSTANTIALLY EQUIVALENT 7
  SUBSTANTIALLY EQUIVALENT - CLIA SUBMISSION 1
BD
  SUBSTANTIALLY EQUIVALENT 1
  SUBSTANTIALLY EQUIVALENT - CLIA SUBMISSION 1
BECKMAN COULTER
  SUBSTANTIALLY EQUIVALENT 1
BIOMEDIX
  SUBSTANTIALLY EQUIVALENT 1
  SUBSTANTIALLY EQUIVALENT - CLIA SUBMISSION 1
BOEHRINGER
  SUBSTANTIALLY EQUIVALENT 17
CARD GUARD SCIENTIFIC SURVIVAL, LTD.
  SUBSTANTIALLY EQUIVALENT - CLIA SUBMISSION 1
CHOLESTECH CORP.
  SUBSTANTIALLY EQUIVALENT 2
DADE BEHRING
  SUBSTANTIALLY EQUIVALENT 1
DOW
  SUBSTANTIALLY EQUIVALENT 1
GAMBRO
  SUBSTANTIALLY EQUIVALENT 1
HEALTH HERO NETWORK, INC.
  SUBSTANTIALLY EQUIVALENT 1
HOME DIAGNOSTICS, INC.
  SUBSTANTIALLY EQUIVALENT 9
HYPOGUARD, LTD.
  SUBSTANTIALLY EQUIVALENT 3
  SUBSTANTIALLY EQUIVALENT - CLIA SUBMISSION 2
INSTRUMENTATION LABORATORY
  SUBSTANTIALLY EQUIVALENT 5
I-STAT
  SUBSTANTIALLY EQUIVALENT - CLIA SUBMISSION 1
JOHNSON & JOHNSON
  SUBSTANTIALLY EQUIVALENT 18
  SUBSTANTIALLY EQUIVALENT - CLIA SUBMISSION 3
KENDALL
  SUBSTANTIALLY EQUIVALENT 1
KULZER
  SUBSTANTIALLY EQUIVALENT 10
LXN CORP.
  SUBSTANTIALLY EQUIVALENT 5
MEDICAL DEVICE CONSULTANTS, INC.
  SUBSTANTIALLY EQUIVALENT 1
MEDICAL SPECIALTIES, INC.
  SUBSTANTIALLY EQUIVALENT 1
NOVA
  SUBSTANTIALLY EQUIVALENT 2
  SUBSTANTIALLY EQUIVALENT - CLIA SUBMISSION 2
ROCHE DIAGNOSTICS CORP.
  SUBSTANTIALLY EQUIVALENT 4
  SUBSTANTIALLY EQUIVALENT - CLIA SUBMISSION 1
TAIDOC TECHNOLOGY CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
  SUBSTANTIALLY EQUIVALENT - CLIA SUBMISSION 9

Device Problems
Unable to obtain readings 32
Incorrect or inadequate result 13
Device displays error message 10
High test results 9
Low test results 8
Failure to power-up 7
Incorrect or inadequate test results 6
Use of Device Issue 4
Shelf life exceeded 3
Improper or incorrect procedure or method 3
Battery issue 1
Low battery 1
Device remains activated 1
Electrical issue 1
Output above specifications 1
Incorrect display 1
Melted 1
Overheating of device or device component 1
User used incorrect product for intended use 1
False negative result 1
Fire 1
Total Device Problems 106

Recalls
  2007 2008 2009 2010 2011 2012 2013
Class I 0 0 0 0 0 0 0
Class II 1 2 2 5 3 1 1
Class III 1 0 0 2 0 1 0

Recalls
Manufacturer Recall Class Date Posted
1 ARKRAY USA INC. II Feb-01-2008
2 ARKRAY USA INC. III Dec-13-2007
3 Abbott Point Of Care Inc. II Dec-10-2010
4 Abbott Point of Care Inc. III Sep-23-2010
5 Abbott Point of Care Inc. II Mar-15-2010
6 Abbott Point of Care Inc. III Feb-24-2010
7 Abbott Point of Care Inc. II Sep-30-2009
8 Beckman Coulter Inc. II Sep-09-2010
9 Biosite Inc Dba Innovacon Inc. II Jun-01-2011
10 Epocal Inc II Jul-19-2012
11 Hemo Cue, Inc. III Jan-20-2012
12 Hemo Cue, Inc. II Mar-30-2011
13 Instrumentation Laboratory Co. II May-10-2011
14 Lifescan Inc II Jan-05-2007
15 Nova Biomedical Corporation II Apr-19-2013
16 Nova Biomedical Corporation II Jun-10-2010
17 Nova Biomedical Corporation II Sep-23-2008
18 Pointe Scientific, Inc. II Mar-12-2009
19 Polymer Technology Systems, Inc. II Mar-05-2010

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