Aptima CMV Quant Assay

FDA premarket approval P210029 · Cytomegalovirus (cmv) dna quantitative assay

PMA numberP210029

Approval

Applicant
Hologic, Inc.
Received
July 26, 2021
Decision date
May 9, 2022 (APRL)
Supplements
2, latest October 23, 2024
Product code
PAB – Cytomegalovirus (Cmv) Dna Quantitative Assay

Official FDA PMA record

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.