| Note: this medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original PMA or panel track supplement and may not represent the most recent labeling. |
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| Device | Aptima CMV Quant Assay |
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| Generic Name | Cytomegalovirus (cmv) dna quantitative assay |
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| Applicant | Hologic, Inc.
10210 Genetic Center Drive
San Diego, CA 92121 |
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| PMA Number | P210029 |
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| Date Received | 07/26/2021 |
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| Decision Date | 05/09/2022 |
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| Product Code |
PAB |
| Docket Number | 22M-2065 |
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| Notice Date | 09/01/2022 |
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| Advisory Committee |
Microbiology |
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| Expedited Review Granted? | No |
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| Combination Product | No |
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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. |
| Approval Order | Approval Order |
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| Summary | Summary of Safety and Effectiveness |
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| Labeling | Labeling
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| Supplements: |
S001 |
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