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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device radioimmunoassay, thyroid-stimulating hormone
Regulation Description Thyroid stimulating hormone test system.
Product CodeJLW
Regulation Number 862.1690
Device Class 2


Premarket Reviews
ManufacturerDecision
ABBOTT
  SUBSTANTIALLY EQUIVALENT 11
  1.  K771235  HTSH RIA HUMAN THYROID HORMONE RIA
  2.  K791747  HTSH NEONATE RIA DIAGNOSTIC KIT
  3.  K822827  HISH EIA DIAGNOSTIC KIT
  4.  K843540  ABBOTT HTSH EIA DIAGNOSTIC KIT
  5.  K880086  ABBOTT IMX HTSH
  6.  K902753  IMX ULTRASENTITIVE HTSH
  7.  K934410  AXSYM ULTRASENSITIVE HTSH
  8.  K942566  IMX ULTRASENSISTIVE HTSH II
  9.  K952148  AXSYM ULTRASENSITIVE HTSH II
  10.  K981060  ABBOTT AXSYM 3RD GENERATION TSH ASSAY
  11.  K983442  ABBOTT ARCHITECT TSH
BAXTER HEALTHCARE CORP.
  SUBSTANTIALLY EQUIVALENT 2
BAYER
  SUBSTANTIALLY EQUIVALENT 1
BECKMAN COULTER
  SUBSTANTIALLY EQUIVALENT 2
BIOMERIEUX
  SUBSTANTIALLY EQUIVALENT 1
Bio-Rad Laboratories
  SUBSTANTIALLY EQUIVALENT 9
BOEHRINGER
  SUBSTANTIALLY EQUIVALENT 3
DADE BEHRING
  SUBSTANTIALLY EQUIVALENT 1
DIAGNOSTIC PRODUCTS
  SUBSTANTIALLY EQUIVALENT 8
DIASORIN
  SUBSTANTIALLY EQUIVALENT 2
EASTMAN KODAK
  SUBSTANTIALLY EQUIVALENT 1
Nichols Institute Diagnostics
  SUBSTANTIALLY EQUIVALENT 3
OLYMPUS
  SUBSTANTIALLY EQUIVALENT 1
ORGANON-TEKNIKA
  SUBSTANTIALLY EQUIVALENT 1
ORTHO-CLINICAL
  SUBSTANTIALLY EQUIVALENT 2
ROCHE DIAGNOSTICS CORP.
  SUBSTANTIALLY EQUIVALENT 1
SCANTIBODIES
  SUBSTANTIALLY EQUIVALENT 1
SIEMENS
  SUBSTANTIALLY EQUIVALENT 3
TERUMO CARDIOVASCULAR SYSTEMS
  SUBSTANTIALLY EQUIVALENT 2

Device Problems
Low test results 71
High test results 67
Incorrect or inadequate test results 55
Incorrect or inadequate result 4
High Readings 2
No Known Device Problem 1
No code available 1
Malfunction 1
Output, low 1
Total Device Problems 203

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

Recalls
Manufacturer Recall Class Date Posted
1 PerkinElmer LAS, Inc II Jan-11-2012
2 Perkinelmer II Aug-01-2012
3 Siemens Healthcare Diagnostics III Jan-07-2013
4 Siemens Healthcare Diagnostics, Inc II May-23-2014
5 Siemens Healthcare Diagnostics, Inc II Aug-06-2013
6 Siemens Healthcare Diagnostics, Inc. II Jun-04-2015
7 Siemens Healthcare Diagnostics, Inc. II Nov-24-2010
8 ThyroTec Inc III Mar-22-2007

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