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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device assay, glycosylated hemoglobin
Regulation Description Glycosylated hemoglobin assay.
Product CodeLCP
Regulation Number 864.7470
Device Class 2


Premarket Reviews
ManufacturerDecision
ABBOTT
  SUBSTANTIALLY EQUIVALENT 8
  1.  K791642  A-GENT GLYCOSPEC
  2.  K832775  A-GENT GLYCOSYLATED HEMOGLOBIN
  3.  K904027  ABBOTT VISION(TM) GLYCATED HB
  4.  K921831  IMX(R) GLYCATED HEMOGLOBIN
  5.  K936285  ABBOTT VISION GLYCATED HB, MODIFICATION
  6.  K983253  PRECISION A1C HOME HBA1C SAMPLE COLLECTION KIT
  7.  K991483  ABBOTT ARCHITECT GLYCATED HEMOGLOBIN
  8.  K992085  ABBOTT IMX GLYCATED HEMOGLOBIN II
ARKRAY USA, INC.
  SUBSTANTIALLY EQUIVALENT 1
BAYER
  SUBSTANTIALLY EQUIVALENT 2
BECKMAN COULTER
  SUBSTANTIALLY EQUIVALENT 5
Bio-Rad Laboratories
  SUBSTANTIALLY EQUIVALENT 15
BOEHRINGER
  SUBSTANTIALLY EQUIVALENT 3
CORDIS CORP.
  SUBSTANTIALLY EQUIVALENT 1
DADE BEHRING
  SUBSTANTIALLY EQUIVALENT 1
EMD
  SUBSTANTIALLY EQUIVALENT 1
GENZYME CORPORATION
  SUBSTANTIALLY EQUIVALENT 2
HOME ACCESS
  SUBSTANTIALLY EQUIVALENT 1
KENDALL
  SUBSTANTIALLY EQUIVALENT 2
KULZER
  SUBSTANTIALLY EQUIVALENT 4
LXN CORP.
  SUBSTANTIALLY EQUIVALENT 1
OLYMPUS
  SUBSTANTIALLY EQUIVALENT 1
ORTHO-CLINICAL
  SUBSTANTIALLY EQUIVALENT 2
PACIFIC HEMOSTASIS
  SUBSTANTIALLY EQUIVALENT 1
POLYMEDCO, INC.
  SUBSTANTIALLY EQUIVALENT 2
ROCHE DIAGNOSTICS CORP.
  SUBSTANTIALLY EQUIVALENT 10
SIEMENS
  SUBSTANTIALLY EQUIVALENT 2
TAIDOC TECHNOLOGY CORPORATION
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
High test results 35
Device ingredient or reagent issue 29
Incorrect or inadequate test results 7
Low test results 5
Nonstandard device or device component 1
Device operates differently than expected 1
No Known Device Problem 1
Total Device Problems 79

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 2 2 4 4 1 2 4 2 2
Class III 0 0 0 1 5 0 0 1 1 0

Recalls
Manufacturer Recall Class Date Posted
1 Alfa Wassermann, Inc. II Dec-17-2008
2 Bayer Healthcare Llc II Nov-02-2013
3 Beckman Coulter Inc. II May-10-2011
4 Bio-Rad Laboratories Inc III Jul-27-2011
5 Bio-Rad Laboratories Inc II Apr-11-2011
6 Bio-Rad Laboratories Inc II Apr-06-2011
7 Bio-Rad Laboratories Inc III Feb-17-2011
8 Bio-Rad Laboratories Inc II Feb-15-2011
9 Bio-Rad Laboratories Inc II Oct-22-2010
10 Bio-Rad Laboratories Inc II Oct-21-2010
11 Bio-Rad Laboratories Inc II Jun-25-2010
12 Bio-Rad Laboratories Inc III Mar-05-2010
13 Bio-Rad Laboratories Inc II Feb-26-2010
14 Bio-Rad Laboratories Inc II May-19-2009
15 Bio-Rad Laboratories Inc II Mar-24-2009
16 Bio-Rad Laboratories, Inc. II Jan-27-2016
17 Bio-Rad Laboratories, Inc. II Mar-27-2014
18 Bio-Rad Laboratories, Inc. III Feb-10-2014
19 Bio-Rad Laboratories, Inc. III Oct-07-2011
20 Bio-Rad Laboratories, Inc. III Sep-06-2011
21 Bio-Rad Laboratories, Inc., Hercules, CA III Apr-13-2011
22 Cholestech Corp II Sep-23-2008
23 Heritage Labs International LLC II Jan-11-2012
24 Metrika Inc II Jun-25-2015
25 Siemens Healthcare Diagnostics II Sep-03-2013
26 Siemens Healthcare Diagnostics, Inc. II Aug-30-2016
27 Siemens Healthcare Diagnostics, Inc. II Nov-25-2015
28 Siemens Healthcare Diagnostics, Inc. II Nov-21-2014
29 Siemens Healthcare Diagnostics, Inc. II Oct-24-2014
30 Siemens Healthcare Diagnostics, Inc. II Jan-03-2014
31 Tosoh Bioscience, Inc. III Jul-14-2015

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