ARCHITECT CORE-M Reagent Kit, Alinity i Anti-HBc IgM Reagent Kit

FDA Premarket Approval P060035 S032

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 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 CORE-M Reagent Kit, Alinity i Anti-HBc IgM Reagent Kit
Generic NameTest, Hepatitis B (b Core, Be Antigen, Be Antibody, B Core Igm)
ApplicantAbbott Laboratories
Date Received2021-02-09
Decision Date2021-04-22
PMAP060035
SupplementS032
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. ap5n-2, Dept. 09vb abbott Park, IL 60064-3500

Supplemental Filings

Supplement NumberDateSupplement Type
P060035Original Filing
S032 2021-02-09 Real-time Process
S031
S030 2020-03-16 Normal 180 Day Track No User Fee
S029 2020-03-16 Normal 180 Day Track No User Fee
S028
S027 2018-10-22 30-day Notice
S026 2018-06-01 Normal 180 Day Track
S025 2015-07-16 30-day Notice
S024 2014-11-13 30-day Notice
S023 2014-09-19 30-day Notice
S022 2013-10-30 30-day Notice
S021 2013-10-28 30-day Notice
S020 2013-02-15 30-day Notice
S019 2013-02-11 30-day Notice
S018 2012-11-19 30-day Notice
S017 2012-11-15 30-day Notice
S016 2012-11-13 30-day Notice
S015 2012-11-01 30-day Notice
S014 2012-08-03 30-day Notice
S013 2011-11-23 Special (immediate Track)
S012 2011-10-28 30-day Notice
S011 2011-10-28 135 Review Track For 30-day Notice
S010 2011-09-07 Special (immediate Track)
S009 2011-05-25 30-day Notice
S008 2011-05-04 Normal 180 Day Track No User Fee
S007 2011-04-18 30-day Notice
S006 2011-02-17 Normal 180 Day Track No User Fee
S005 2011-01-10 135 Review Track For 30-day Notice
S004 2010-12-22 Special (immediate Track)
S003 2010-11-01 Normal 180 Day Track No User Fee
S002 2010-08-02 Normal 180 Day Track No User Fee
S001 2009-01-08 Normal 180 Day Track

NIH GUDID Devices

Device IDPMASupp
00380740011154 P060035 001
00380740011147 P060035 001
00380740011130 P060035 001
00380740146177 P060035 026
00380740145187 P060035 026
00380740130282 P060035 026

© 2021 FDA.report
This site is not affiliated with or endorsed by the FDA.