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

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


New Search Back to Search Results
Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceElecsys HBsAg II Auto Confirm
Generic NameTest, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
Regulation Number866.3172
ApplicantRoche Diagnostics, Inc.
9115 Hague Rd.
Indianapolis, IN 46038
PMA NumberP160019
Supplement NumberS011
Date Received11/27/2019
Decision Date10/19/2020
Reclassified Date10/20/2025
Product Code LOM 
Advisory Committee Microbiology
Supplement TypeNormal 180 Day Track
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval for 1) the Elecsys HBsAg II Auto Confirm: Immunoassay for in vitro qualitative confirmation of the presence of hepatitis B surface antigen in human serum and plasma (sodium heparin, lithium heparin, K2-EDTA, sodium citrate) samples repeatedly reactive when tested with the Elecsys HBsAg II assay. The electrochemiluminescence immunoassay ECLIA is intended for use on cobas e immunoassay analyzers;2) the PreciControl HBsAg Auto Confirm: PreciControl HBsAg Auto Confirm is used for quality control of the Elecsys HBsAg II Auto Confirm Immunoassay on the cobas e 801 immunoassay analyzer; and 3) the PreciControl HBsAg II: PreciControl HBsAg II is used for quality control of the Elecsys HBsAg II and Elecsys HBsAg II Auto Confirm immunoassays on the cobas e immunoassay analyzers. The performance of PreciControl HBsAg II has not been established with any other HBsAg assay.
-
-