# K920661: Vidas CMV Igg Assay

- Pathway: 510(k) (Traditional)
- Applicant: Vitek Systems, Inc.
- Decided: Feb 12, 1993 after 365 days
- Product code: LFZ (Enzyme Linked Immunoabsorbent Assay, Cytomegalovirus)
- Device class: 2
- Regulation: 21 CFR 866.3175
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
4 later devices descend from it; 3 cite it directly.
0 of 5 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
- K181213: ADVIA Centaur CMV IgG and ADVIA Centaur CMV IgG Quality Control (2018), 1 descendant of its own
- K080008: Bioplex 2200 System Torc Igg Kit, Calibrator Set and Control Set (2009), 1 descendant of its own
- K220949: Architect CMV IgG (2022), 0 descendants of its own
- K120572: Bioplex 2200 Torc Igg (2012), 0 descendants of its own

## Recalls of this device
- Jun 9, 2004 · Not classified · Z-1047-04: The product may give false positive results.

Source page: https://510kreport.com/device/K920661
Methodology: https://510kreport.com/methodology