• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Premarket Approval (PMA)

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


New Search Back to Search Results
Note: this medical device record is a supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
 
Trade NameELECSYS ANTI-HBC IMMUNOASSAY AND ELECSYS PRECICONTROL ANTI-HBC
Classification Nametest, hepatitis b (b core, be antigen, be antibody, b core igm)
ApplicantROCHE DIAGNOSTICS CORP.
PMA NumberP100031
Supplement NumberS009
Date Received09/04/2012
Decision Date08/12/2013
Product Code
LOM[ Registered Establishments with LOM ]
Advisory Committee Microbiology
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - software
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the migration of claims from the fda approved elecsys anti-hbc immunoassay and elecsys precicontrol anti-hbc on the modular analytics e170 to the cobas e 602 immunoassay analyzer. The device, as modified, will be marketed under the trade name elecsys anti-hbc immunoassay and elecsys precicontrol anti-hbc and is indicated for: elecsys anti-hbc immunoassay the elecsys anti-hbc immunoassay is intended for the in vitro qualitative determination of total antibodies to hepatitis b core antigen (anti-hbc) in human serum and plasma (lithium heparin, sodium citrate, k2-edta) in adult patients with the symptoms of hepatitis or who may be at risk for hepatitis b virus (hbv) infection. The detection of total anti-hbc is indicative of a laboratory diagnosis for hbv infection. Further hbv serological marker testing is required to define the specific disease state. The elecsys anti-hbc immunoassays performance has not been established for the monitoring of hbv disease or therapy. The electrochemiluminescence immunoassay eclia is intended for use on the modular analytics e170 and cobas e 602 immunoassay analyzers. Elecsys precicontrol anti-hbc precicontrol anti hbc is used for quality control of the elecsys anti hbc immunoassay on the modular analytics e170 and cobas e 602 immunoassay analyzers.
-
-