Alinity m HBV

FDA Premarket Approval P200013 S009

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

DeviceAlinity m HBV
Generic NameHepatitis Viral B Dna Detection
ApplicantAbbott Molecular, Inc.1300 E Touhy Avedes Plaines, IL 60018 PMA NumberP200013 Supplement NumberS009 Date Received09/21/2022 Decision Date10/24/2022 Product Code MKT  Advisory Committee Microbiology Supplement Typespecial (immediate Track) Supplement Reason Labeling Change - Indications/instructions/shelf Life/tradename Expedited Review Granted? No
Date Received2022-09-21
Decision Date2022-10-24
PMAP200013
SupplementS009
Product CodeMKT 
Advisory CommitteeMicrobiology
Supplement TypeSpecial (immediate Track)
Supplement ReasonLabeling Change - Indications/instructions/shelf Life/tradename
Expedited ReviewNo
Combination ProductNo
Applicant AddressAbbott Molecular, Inc.
1300 E Touhy Ave
des Plaines, IL 60018 PMA NumberP200013 Supplement NumberS009 Date Received09/21/2022 Decision Date10/24/2022 Product Code MKT  Advisory Committee Microbiology Supplement Typespecial (immediate Track) Supplement Reason Labeling Change - Indications/instructions/shelf Life/tradename Expedited Review Granted? No Combination ProductNo Approval Order Statement  
Approval Is For The Following Addition To Limitations Of The Procedure: “Unexpected HBV DNA Levels Due To Carry Over May Occur. If Results Are Inconsistent With Patient History And Other Diagnostics Through Patient Monitoring, A Retest Of The Sample Should Be Considered By The Physician Or Healthcare Provider.” Approval Is Also For The Following Change To The Specific Performance Characteristic – Carryover Section: The Carryover Rate For Alinity M HBV Was Determined In Two Studies. Study 1 Evaluated The Carryover Rate In The Sample Input Rack And Sample Processing Unit By Analyzing 360 Valid Replicates Of HBV Negative Samples Processed From Alternating Positions In The Sample Input Rack With 360 Valid Replicates Of High Concentrated HBV Positive Samples At 100,000,000 IU/mL, Across Multiple Runs. HBV DNA Was Not Detected In Any Of The HBV Negative Samples, Resulting In A Carryover Rate Of 0% (95% CI: 0.0 To 1.1%). Study 2 Evaluated The Carryover Rate In The AMP Tray By Evaluating 414 Valid Replicates Of HBV Negative Samples Processed From Alternating Positions At The AMP Tray With 414 Valid Replicates Of High Concentrated HBV Positive Samples At 100,000,000 IU/mL Across Multiple Runs. HBV DNA Was Detected In 16 Of The HBV Negative Samples Resulting In A Carryover Rate Of 3.9% (95% CI: 2.2 To 6.2%).

Supplemental Filings

Supplement NumberDateSupplement Type
P200013Original Filing
S009 2022-09-21 Special (immediate Track)
S008 2022-05-10 30-day Notice
S007
S006 2022-02-17 30-day Notice
S005 2021-04-15 Real-time Process
S004 2021-02-05 30-day Notice
S003 2021-02-05 30-day Notice
S002
S001 2020-12-21 30-day Notice

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