PMA P170025S019

Device: Aptima HBV Quant Assay
Applicant: Hologic, Inc.
PMA number: P170025
Supplement: S019
Product code: MKT
Decision date: 2024-06-17
Classification: Microbiology
Generic name: Hepatitis Viral B DNA Detection
Approval order statement: Approval for 1) use of Aptima HBV Quant Assay using new estimated background minimum limits to detect, flag and invalidate test results due to a faulty lamp and 2) increase reagent on-board/off-board cycles from 5 cycles to 8 cycles

Current openFDA PMA Record#

Device: Aptima HBV Quant Assay
Applicant: Hologic, Inc.
PMA number: P170025
Supplement: S019
Product code: MKT
Generic name: Hepatitis Viral B DNA Detection
Decision date: 2024-06-17
Decision code: APPR
Date received: 2023-09-29
Supplement type: Normal 180 Day Track
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: Approval for 1) use of Aptima HBV Quant Assay using new estimated background minimum limits to detect, flag and invalidate test results due to a faulty lamp and 2) increase reagent on-board/off-board cycles from 5 cycles to 8 cycles