ARCHITECT HBsAg Qualitative Reagent, ARCHITECT HBsAg Qualitative Confirmatory Reagent, Alinity i HBsAg Qualitative II Re

FDA Premarket Approval P110029 S034

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 to modify the architect i1000sr probe wash with an alternate wash delivery system (awds), and to modify the architect i2000sr and alinity i with induction heating (ih).

DeviceARCHITECT HBsAg Qualitative Reagent, ARCHITECT HBsAg Qualitative Confirmatory Reagent, Alinity i HBsAg Qualitative II Re
Generic NameTest, Hepatitis B (b Core, Be Antigen, Be Antibody, B Core Igm)
ApplicantAbbott Laboratories
Date Received2021-02-09
Decision Date2021-04-22
PMAP110029
SupplementS034
Product CodeLOM 
Advisory CommitteeMicrobiology
Supplement TypeReal-time Process
Supplement ReasonChange Design/components/specifications/material
Expedited ReviewNo
Combination Product No
Applicant Address Abbott Laboratories 100 Abbott Park Rd. dept 09v6, Bldg. Ap5-2 abbott Park, IL 60064-6088

Supplemental Filings

Supplement NumberDateSupplement Type
P110029Original Filing
S034 2021-02-09 Real-time Process
S033 2020-07-02 30-day Notice
S032 2020-03-16 Normal 180 Day Track No User Fee
S031 2020-03-16 Normal 180 Day Track No User Fee
S030
S029 2019-08-01 Normal 180 Day Track
S028 2018-10-16 30-day Notice
S027 2018-06-27 30-day Notice
S026 2017-06-30 Real-time Process
S025
S024 2016-10-14 30-day Notice
S023 2016-03-10 30-day Notice
S022 2015-07-16 30-day Notice
S021 2015-06-15 30-day Notice
S020 2014-12-04 30-day Notice
S019 2014-11-14 30-day Notice
S018 2014-11-13 30-day Notice
S017 2014-03-18 30-day Notice
S016 2013-11-01 30-day Notice
S015 2013-10-30 30-day Notice
S014 2013-10-28 30-day Notice
S013 2013-09-24 30-day Notice
S012 2013-07-17 30-day Notice
S011 2013-02-11 30-day Notice
S010 2012-11-19 30-day Notice
S009 2012-11-15 30-day Notice
S008 2012-11-13 30-day Notice
S007 2012-11-01 30-day Notice
S006 2012-10-26 30-day Notice
S005 2012-09-17 30-day Notice
S004 2012-08-17 30-day Notice
S003 2012-08-03 30-day Notice
S002 2012-06-06 30-day Notice
S001 2012-05-01 Normal 180 Day Track

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