Aptima CMV Quant Assay

FDA Premarket Approval P210029

Pre-market Approval Supplement Details

DeviceAptima CMV Quant Assay
Generic NameCytomegalovirus (cmv) Dna Quantitative Assay
ApplicantHologic, Inc.10210 Genetic Center Drivesan Diego, CA 92121 PMA NumberP210029 Date Received07/26/2021 Decision Date05/09/2022 Product Code PAB  Advisory Committee Microbiology Expedited Review Granted? No
Date Received2021-07-26
Decision Date2022-05-09
PMAP210029
SupplementS
Product CodePAB 
Advisory CommitteeMicrobiology
Expedited ReviewNo
Combination ProductNo
Applicant AddressHologic, Inc.
10210 Genetic Center Drive
san Diego, CA 92121 PMA NumberP210029 Date Received07/26/2021 Decision Date05/09/2022 Product Code PAB  Advisory Committee Microbiology Expedited Review Granted? No Combination ProductNo Approval Order Statement  
Approval Of The Aptima CMV Quant Assay - This Device Is Approved For:The Aptima CMV Quant Assay Is An In Vitro Nucleic Acid Amplification Test For The Quantitation Of Human Cytomegalovirus (CMV) DNA In Human EDTA Plasma On The Fully Automated Panther System. The Aptima CMV Quant Assay Is Intended For Use To Aid In The Management Of Solid-organ Transplant Patients And Hematopoietic Stem Cell Transplant Patients. In Patients Receiving Anti-CMV Therapy, Serial DNA Measurements Can Be Used To Assess Viral Response To Treatment. The Results From Aptima CMV Quant Assay Must Be Interpreted Within The Context Of All Relevant Clinical And Laboratory Findings.Aptima CMV Quant Assay Is Not Intended For Use As A Screening Assay For The Presence Of CMV In Blood Or Blood Products. Supplements:  

Supplemental Filings

Supplement NumberDateSupplement Type
P210029Original Filing
S001 2022-06-16 30-day Notice

NIH GUDID Devices

Device IDPMASupp
15420045514584 P210029 000
15420045514577 P210029 000
15420045514560 P210029 000
15420045514553 P210029 000

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