# K100433: Immulite 2000 CMV Igm, Immulite CMV Igm Controls, and Immulite 200 CMV Igm Adjustor Model L2KCM2, L2KCM6, LCMC1, LCMC2,

- Pathway: 510(k) (Traditional)
- Applicant: Siemens Healthcare Diagnostics
- Decided: May 13, 2010 after 86 days
- Product code: LKQ (Antibody Igm,If, Cytomegalovirus Virus)
- Device class: 2
- Regulation: 21 CFR 866.3175
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K933549 (1994). 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)
- K933549: Vidas CMV Igm Assay, Biomerieux Vitek, Inc. (1994) Summary page 1.

## Recalls of this device
- Aug 30, 2016 · Class II · Z-0319-2017: Multiple customers reported seeing an increase in imprecision with some patients resulting in high % CVs with the IMMULITE 2000/2000XPi CMV (IgM) assay starting with reagent lots 259 and above.
- Aug 30, 2016 · Class II · Z-0320-2017: Multiple customers reported seeing an increase in imprecision with some patients resulting in high % CVs with the IMMULITE 2000/2000XPi CMV (IgM) assay starting with reagent lots 259 and above.

## Indications for use
IMMULITE® 2000 CMV IgM is for in vitro diagnostic use with IMMULITEO 2000 Systems analyzers for the qualitative detection of IgM antibodies to cytomegalovirus (CMV) in human serum or plasma (EDTA or heparinized), as an aid in the diagnosis of current and recent CMV infection in individuals with signs and symptoms of CMV infection or clinical suspicion of CMV infection. This assay is not FDA cleared or approved for use in testing (screening) blood or plasma donors, neonatal screening, or for use at point-of-care facilities. Performance characteristics for this assay have not been established in immunocompromised, immunosuppressed or organ transplant individuals. CMV IgM Controls are assayed, bi-level controls intended for use with the IMMULITE 2000 CMV igM assay. They are intended as an aid in monitoring day-to-day assay performance.

Source page: https://510kreport.com/device/K100433
Methodology: https://510kreport.com/methodology