# K933549: Vidas CMV Igm Assay

- Pathway: 510(k) (Traditional)
- Applicant: Biomerieux Vitek, Inc.
- Decided: Aug 2, 1994 after 376 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
No predicates in its family tree.
3 later devices descend from it; 2 cite it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K092587: Bioplex 2200 Rubella & CMV Igm Kit on the Bioplex 2200 Multi Analyte Detection System (2010), 1 descendant of its own
- K170509: BioPlex 2200 ToRC IgM, BioPlex 2200 ToRC IgM Calibrator Set, BioPlex 2200 ToRC IgM Control Set (2017), 0 descendants of its own
- K100433: Immulite 2000 CMV Igm, Immulite CMV Igm Controls, and Immulite 200 CMV Igm Adjustor Model L2KCM2, L2KCM6, LCMC1, LCMC2, (2010), 0 descendants of its own

## Recalls of this device
- Feb 9, 2022 · Class II · Z-0742-2022: Invalid calibrations (out of range high) while using the product.
- Mar 16, 2021 · Class II · Z-1408-2021: bioMerieux received complaints about calibration issue observed on several lots of VIDAS¿ CMV IgM (ref 30205 ; 30205-01).

Source page: https://510kreport.com/device/K933549
Methodology: https://510kreport.com/methodology