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.
| Device | Alinity m HBV |
| Generic Name | Hepatitis Viral B Dna Detection |
| Applicant | Abbott 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 Received | 2022-09-21 |
| Decision Date | 2022-10-24 |
| PMA | P200013 |
| Supplement | S009 |
| Product Code | MKT |
| Advisory Committee | Microbiology |
| Supplement Type | Special (immediate Track) |
| Supplement Reason | Labeling Change - Indications/instructions/shelf Life/tradename |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | Abbott 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%). |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P200013 | Original Filing | |
| S012 | 2022-12-20 | 30-day Notice |
| S011 | 2022-12-07 | Special (immediate Track) |
| S010 | ||
| 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 |