# K142133: Elecys CMV Igm Immunoassay; Elecys Precicontrol CMV Igm

- Pathway: 510(k) (Traditional)
- Applicant: Roche Diagnostics
- Decided: Oct 24, 2014 after 81 days
- Product code: LFZ (Enzyme Linked Immunoabsorbent Assay, 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: 6 generations back to K931172 (1993). 9 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K001767: Diamedix IS-CMV Igm Capture Test System, Diamedix Corp. (2000) Summary page 4.
- K092322: Elecsys Rubella Igm Immunoassay, Roche Diagnostics (2010) Summary page 4.

## Most influential descendants
- K163569: Elecsys CMV IgM (2017), 0 descendants of its own

## Indications for use
(1) Immunoassay for the in vitro qualitative detection of IgM antibodies to CMV in human serum, lithium-heparin plasma, K2-EDTA plasma, and K3-EDTA plasma. The test is intended as an aid in the diagnosis of recent or current CMYV infection in individuals for which a CMV IgM test was ordered, including pregnant women. Performance characteristics have not been evaluated in immunocompromised or immunosuppressed individuals. This test is not intended for use in neonatal screening or for use at point of care facilities. This assay is not intended for use in screening blood and plasma donors. The electrochemiluminescence immunoassay "ECLIA" is intended for use on Elecsys immunoassay analyzers. (2) PreciControl CMV IgM is used for quality control of the Elecsys CMV IgM immunoassay on the Elecsys and cobas e immunoassay analyzers.

Source page: https://510kreport.com/device/K142133
Methodology: https://510kreport.com/methodology