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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 15
AMIRA MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 2
ARKRAY USA, INC.
  SUBSTANTIALLY EQUIVALENT 1
BAYER
  SUBSTANTIALLY EQUIVALENT 8
BD
  SUBSTANTIALLY EQUIVALENT 2
BECKMAN COULTER
  SUBSTANTIALLY EQUIVALENT 1
BIOMEDIX
  SUBSTANTIALLY EQUIVALENT 2
BOEHRINGER
  SUBSTANTIALLY EQUIVALENT 17
  1.  K761148  REFLOMAT/REFLOTEST SYSTEM
  2.  K781075  STATTEK-GLUCOSE LOW LEVEL
  3.  K834271  REFLOCHECK & GLUCOSE TEST STRIP SYS
  4.  K840962  REFLOCHECK-S
  5.  K842393  BOEHRINGER MANNHEIM DIAG. BLOOD GLUCOSE
  6.  K851456  ACCU-CHEK II
  7.  K860948  TRACKER SYSTEM
  8.  K863481  MODIFICATION OF ACCU-CHEK II
  9.  K881908  TRACER(TM) II BLOOD GLUCOSE SYSTEM
  10.  K883817  ACCUCHEK II FREEDOM(TM) MONITORING SYSTEM
  11.  K904168  ACCU-CHEK (R) EASY (TM) BLOOD GLUCOSE SYSTEM
  12.  K904292  ACCU-CHEK(R) III BLOOD GLUCOSE SYSTEM
  13.  K923048  ACCU-CHEK EASY BLOOD GLUCOSE SYSTEM
  14.  K924475  ACCUDATA GLUCOSE TEST STATION
  15.  K930979  ACCU-CHEK ADVANTAGE BLOOD GLUCOSE SYSTEM
  16.  K944459  ACCU-CHEK INSTANT PLUS G-C/DM BLOOD GLUCOSE MONITO ...
  17.  K952875  ACCU-CHEK ALPHA MONITOR & ACCU-CHEK GLUCOSE TEST S ...
CARD GUARD SCIENTIFIC SURVIVAL, LTD.
  SUBSTANTIALLY EQUIVALENT 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 5
INSTRUMENTATION LABORATORY
  SUBSTANTIALLY EQUIVALENT 5
I-STAT
  SUBSTANTIALLY EQUIVALENT 1
JOHNSON & JOHNSON
  SUBSTANTIALLY EQUIVALENT 21
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 8
ROCHE DIAGNOSTICS CORP.
  SUBSTANTIALLY EQUIVALENT 5
SENDX MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
TAIDOC TECHNOLOGY CORPORATION
  SUBSTANTIALLY EQUIVALENT 10

Device Problems
High test results 146
Low test results 62
Incorrect or inadequate test results 38
Unable to obtain readings 32
Incorrect or inadequate result 20
Device displays error message 11
Failure to power-up 9
Image display error 7
Overheating of device or device component 6
Device operates differently than expected 4
Use of Device Issue 4
Improper or incorrect procedure or method 3
High Readings 3
Shelf life exceeded 3
Smoking 3
Device emits odor 3
Burn of device or device component 2
Circuit Failure 2
Incorrect display 2
Melted 2
Noise, Audible 2
Battery issue 1
Out-of-box failure 1
Low battery 1
Electrical issue 1
False negative result 1
Fire 1
Output above specifications 1
No device output 1
Mechanical issue 1
Device remains activated 1
Loss of power 1
User used incorrect product for intended use 1
Total Device Problems 376

Recalls
  2007 2008 2009 2010 2011 2012 2013 2014 2015 2016
Class I 0 0 0 0 0 0 0 1 0 1
Class II 1 2 2 5 3 1 4 3 3 1
Class III 1 0 0 2 0 1 1 0 0 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 Alere San Diego, Inc. III Nov-22-2013
9 Arkray Factory USA, Inc. I Jan-15-2016
10 Beckman Coulter Inc. II Sep-09-2010
11 Biosite Inc Dba Innovacon Inc. II Jun-01-2011
12 DIABETIC SUPPLY OF SUNCOAST, INC. I Jul-22-2014
13 ELITech Clinical Systems SAS II Nov-05-2015
14 Epocal II Aug-14-2013
15 Epocal Inc II Jul-19-2012
16 Hemo Cue, Inc. III Jan-20-2012
17 Hemo Cue, Inc. II Mar-30-2011
18 HemoCue AB II Sep-11-2013
19 Instrumentation Laboratory Co. II May-10-2011
20 JAS Diagnostics Inc. II Jun-25-2014
21 Lifescan Inc II Jan-05-2007
22 Nova Biomedical Corporation II Jan-09-2014
23 Nova Biomedical Corporation II Apr-19-2013
24 Nova Biomedical Corporation II Jun-10-2010
25 Nova Biomedical Corporation II Sep-23-2008
26 Ortho-Clinical Diagnostics II Nov-15-2013
27 Pointe Scientific, Inc. II Mar-12-2009
28 Polymer Technology Systems, Inc. II Mar-05-2010
29 Radiometer America Inc II Dec-24-2014
30 Roche Diagnostics Operations, Inc. II Feb-02-2015
31 Siemens Healthcare Diagnostics, Inc II Jul-02-2015
32 Siemens Healthcare Diagnostics, Inc. II May-11-2016

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