# K243935: Aptima CMV Quant Assay

- Pathway: 510(k) (Special)
- Applicant: Hologic, Inc.
- Decided: Jan 17, 2025 after 28 days
- Product code: PAB (Cytomegalovirus (Cmv) Dna Quantitative Assay)
- Device class: 2
- Regulation: 21 CFR 866.3180
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to P210029 (2022). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- P210029: Aptima CMV Quant Assay, Hologic, Inc. (2022) Summary page 5.

## Indications for use
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. The Aptima CMV Quant Assay is not intended for use as a screening assay for the presence of CMV in blood or blood products.

Source page: https://510kreport.com/device/K243935
Methodology: https://510kreport.com/methodology