# K183571: Capture-CMV

- Pathway: 510(k) (Traditional)
- Applicant: Immucor, Inc.
- Decided: Feb 4, 2019 after 45 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: 1 generation back to K910003 (1991). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K910003: Cytomegalovirus Antibody Screen, Immucor, Inc. (1991) Summary page 4.

## Most influential descendants
- K203612: Capture-CMV (2021), 0 descendants of its own

## 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 blood and plasma donors or patients for serological evidence of previous infection by CMV.

Source page: https://510kreport.com/device/K183571
Methodology: https://510kreport.com/methodology