# K203612: Capture-CMV

- Pathway: 510(k) (Traditional)
- Applicant: Immucor, Inc.
- Decided: Mar 22, 2021 after 102 days
- Product code: LJO (Antigen, Iha, Cytomegalovirus)
- Device class: 2
- Regulation: 21 CFR 866.3175
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K910003 (1991). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K183571: Capture-CMV, Immucor, Inc. (2019) Summary page 4.

## Indications for use
Capture-CMV® is an in vitro qualitative solid phase red cell adherence test system for the detection of antibodies (IgG plus IgM) to cytomegalovirus (CMV) in human serum or plasma. Capture-CMV® is intended to be used in screening of patients for serological evidence of previous infection by CMV using manual and semi-automated methods, NEO Iris® and Galileo NEO®.

Source page: https://510kreport.com/device/K203612
Methodology: https://510kreport.com/methodology