Elecsys HBsAg II, Elecsys HBsAg Confirmatory Test, and PreciControl HBsAg II

FDA Premarket Approval P160019 S010

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

Approval for (1) the inclusion of a biotin scavenger antibody in reagent 2 of the test kit to increase the biotin tolerance of the assay and (2) the proposed labeling changes for elecsys hbsag ii and elecsys hbsag confirmatory test.

DeviceElecsys HBsAg II, Elecsys HBsAg Confirmatory Test, and PreciControl HBsAg II
Generic NameTest, Hepatitis B (b Core, Be Antigen, Be Antibody, B Core Igm)
Date Received2019-09-03
Decision Date2020-02-27
Product CodeLOM 
Advisory CommitteeMicrobiology
Supplement TypeNormal 180 Day Track
Supplement ReasonChange Design/components/specifications/material
Expedited ReviewNo
Combination Product No
Applicant Address ROCHE DIAGNOSTICS, INC. 9115 Hague Road indianapolis, IN 46038

Supplemental Filings

Supplement NumberDateSupplement Type
P160019Original Filing
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


Device IDPMASupp
07613336106402 P160019 000
07613336106396 P160019 000
04015630911110 P160019 000

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