PMA P210022S008

Device: Alinity m CMV
Applicant: Abbott Molecular, Inc.
PMA number: P210022
Supplement: S008
Product code: PAB
Decision date: 2024-01-16
Classification: Microbiology
Generic name: Cytomegalovirus (cmv) dna quantitative assay
Approval order statement: Approval for a change of the Alinity m CMV Assay to implement a new application specification file containing an improved PCR reagent assembly process that mitigates the potential for overflow at the Alinity m Amplification (AMP) Tray, thus minimizing the potential risk for carryover. The Alinity m CMV Kit package insert is also being updated to reflect the carryover rate using the new application specification file.

Current openFDA PMA Record#

Device: Alinity m CMV
Applicant: Abbott Molecular, Inc.
PMA number: P210022
Supplement: S008
Product code: PAB
Generic name: Cytomegalovirus (cmv) dna quantitative assay
Decision date: 2024-01-16
Decision code: APPR
Date received: 2023-10-18
Supplement type: Real-Time Process
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: Approval for a change of the Alinity m CMV Assay to implement a new application specification file containing an improved PCR reagent assembly process that mitigates the potential for overflow at the Alinity m Amplification (AMP) Tray, thus minimizing the potential risk for carryover. The Alinity m CMV Kit package insert is also being updated to reflect the carryover rate using the new application specification file.