Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | Registration & Listing | Adverse Events | Recalls | PMA | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

New Search Back To Search Results
Device test, epithelial ovarian tumor-associated antigen (ca125)
Regulation Description Tumor-associated antigen immunological test system.
Product CodeLTK
Regulation Number 866.6010
Device Class 2


Premarket Reviews
ManufacturerDecision
ABBOTT
  SUBSTANTIALLY EQUIVALENT 2
BAYER
  SUBSTANTIALLY EQUIVALENT 3
BECKMAN COULTER
  SUBSTANTIALLY EQUIVALENT - CLIA SUBMISSION 2
BIOMERIEUX
  SUBSTANTIALLY EQUIVALENT - CLIA SUBMISSION 2
BOEHRINGER
  SUBSTANTIALLY EQUIVALENT 2
DIAGNOSTIC PRODUCTS
  SUBSTANTIALLY EQUIVALENT 2
ORTHO-CLINICAL
  SUBSTANTIALLY EQUIVALENT 1
SIEMENS
  SUBSTANTIALLY EQUIVALENT - CLIA SUBMISSION 1

Device Problems
High test results 16
Incorrect or inadequate test results 14
Defective item 4
Low test results 1
False positive result 1
Incorrect or inadequate result 1
Total Device Problems 37

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

Recalls
Manufacturer Recall Class Date Posted
1 Abbott Laboratories II Jul-11-2007
2 BioCheck Inc II Mar-11-2011
3 Siemens Healthcare Diagnostics, Inc II Mar-02-2011

-
-