Elecsys HBsAg II

FDA Premarket Approval P160019 S013

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.

Pre-market Approval Supplement Details

To improve and expand manufacturing of kit components

DeviceElecsys HBsAg II
Generic NameTest, Hepatitis B (b Core, Be Antigen, Be Antibody, B Core Igm)
ApplicantROCHE DIAGNOSTICS, INC.
Date Received2021-11-29
Decision Date2021-12-16
PMAP160019
SupplementS013
Product CodeLOM 
Advisory CommitteeMicrobiology
Supplement Type30-day Notice
Supplement ReasonProcess Change - Manufacturer/sterilizer/packager/supplier
Expedited ReviewNo
Combination Product No
Applicant Address ROCHE DIAGNOSTICS, INC. 9115 Hague Road indianapolis, IN 46038

Supplemental Filings

Supplement NumberDateSupplement Type
P160019Original Filing
S013 2021-11-29 30-day Notice
S012 2021-08-02 Normal 180 Day Track
S011 2019-11-27 Normal 180 Day Track
S010 2019-09-03 Normal 180 Day Track
S009 2018-10-26 Normal 180 Day Track No User Fee
S008 2018-10-09 30-day Notice
S007 2018-04-17 Real-time Process
S006 2017-10-11 Real-time Process
S005 2017-08-03 30-day Notice
S004 2017-07-28 Normal 180 Day Track
S003 2017-07-28 Normal 180 Day Track
S002 2017-05-24 30-day Notice
S001 2017-05-09 Normal 180 Day Track

NIH GUDID Devices

Device IDPMASupp
07613336106402 P160019 000
07613336106396 P160019 000
04015630911110 P160019 000
07613336198285 P160019 010
07613336198278 P160019 010
07613336168103 P160019 010
07613336172902 P160019 011
07613336164372 P160019 011

© 2022 FDA.report
This site is not affiliated with or endorsed by the FDA.