# K153538: Dextramer CMV Kit

- Pathway: 510(k) (Traditional)
- Applicant: Immudex Aps
- Decided: Mar 2, 2017 after 448 days
- Product code: GKZ (Counter, Differential Cell)
- Device class: 2
- Regulation: 21 CFR 864.5220
- 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 K051122 (2005). 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)
- K051122: Itag MHC Tetramer CMV Assay, Beckman Coulter, Inc. (2005) Summary page 5.

## Indications for use
Dextramer® CMV Kit is a semi-quantitative assay intended for the identification and enumeration of cytomegalovirus (CMV)-specific CD8+ T cells in anticoagulated (Na Heparin) whole blood specimens by flow cytometry. Dextramer® CMV Kit is indicated for assessment of CMV-specific immune status and risk of CMV reactivation in adult human stem cell transplant patients following immunosuppression and used in conjunction with other laboratory and clinical findings. The kit cannot be used to measure CMV infection or disease. The kit is limited to individuals with the following HLA types: A*0101, A*0201, B*0702, B*0801, B*3501. Special instrument requirements: FACSCanto II flow cytometer (Becton Dickinson).

Source page: https://510kreport.com/device/K153538
Methodology: https://510kreport.com/methodology