# K252481: cobas CMV

- Pathway: 510(k) (Traditional)
- Applicant: Roche Molecular Systems, Inc.
- Decided: Nov 3, 2025 after 88 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 P160041 (2017). 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)
- P160041: Cobas CMV, Roche Molecular Systems, Inc. (2017) Summary page 7.

## Indications for use
cobas CMV is an in vitro nucleic acid amplification test for the quantitation of cytomegalovirus (CMV) DNA in human EDTA plasma. cobas CMV is intended for use as an aid in the management of CMV in solid organ transplant patients and in 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 cobas CMV must be interpreted within the context of all relevant clinical and laboratory findings. cobas CMV is not intended for use as a screening test for blood or blood products.

Source page: https://510kreport.com/device/K252481
Methodology: https://510kreport.com/methodology