# K051122: Itag MHC Tetramer CMV Assay

- Pathway: 510(k) (Traditional)
- Applicant: Beckman Coulter, Inc.
- Decided: Aug 1, 2005 after 91 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
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names no predicate by number.

## Most influential descendants
- K153538: Dextramer CMV Kit (2017), 0 descendants of its own

## Indications for use
Beckman Coulter's iTAg MHC Tetramer-CMV is for the identification and enumeration of cytomegalovirus (CMV) -specific CD8+ lymphocytes in whole blood by flow cytometry, and for the assessment of CMV-specific immune status and risk of CMV reactivation in immunosuppressed stem cell transplant recipients. The assay is limited to individuals with the following HLA types: A*0101, A*0201, B*0702, B*0801,B*3501.

Source page: https://510kreport.com/device/K051122
Methodology: https://510kreport.com/methodology