# K923122: Vitek Immunodiagnostic Assay System

- Pathway: 510(k) (Traditional)
- Applicant: Biomerieux Vitek, Inc.
- Decided: Oct 26, 1992 after 122 days
- Product code: LFY (Enzyme Linked Immunoabsorbent Assay, Varicella-Zoster)
- Device class: 2
- Regulation: 21 CFR 866.3900
- 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; 1 cites 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
- K091616: Bioplex 2200 MMRV Igg (2010), 2 descendants of its own
- K212769: DYNEX SmartPLEX MMRV IgG Assay Kit (2023), 0 descendants of its own
- K111072: Bioplex 2200 MMRV Igg IT on Bioplex 2200 Multi-Analyte Detection System, Bioplex 2200 MMRV Igg Calibrator Set, and Biopl (2011), 0 descendants of its own

## Recalls of this device
- Nov 9, 2022 · Class II · Z-0795-2023: As the temperature and time out of range was exceeded, product performances cannot be guaranteed
- Dec 10, 2019 · Class II · Z-1107-2020: Two batches of VIDAS Varicella-Zoster IgG (VZG ref 30217) may yield an invalid calibration which may delay the patient's sample result or a valid calibration may lead to a false positive patient resul

Source page: https://510kreport.com/device/K923122
Methodology: https://510kreport.com/methodology