| Device | Aptima CMV Quant Assay |
| Generic Name | Cytomegalovirus (cmv) Dna Quantitative Assay |
| Applicant | Hologic, 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 Received | 2021-07-26 |
| Decision Date | 2022-05-09 |
| PMA | P210029 |
| Supplement | S |
| Product Code | PAB |
| Advisory Committee | Microbiology |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | Hologic, 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: |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P210029 | Original Filing | |
| S001 | 2022-06-16 | 30-day Notice |
| Device ID | PMA | Supp |
|---|---|---|
| 15420045514584 | P210029 | 000 |
| 15420045514577 | P210029 | 000 |
| 15420045514560 | P210029 | 000 |
| 15420045514553 | P210029 | 000 |