510(k) · Cleared
Recalled · Class II · 2022Vitek Immunodiagnostic Assay System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Biomerieux Vitek, Inc. · LFY Enzyme Linked Immunoabsorbent Assay, Varicella-Zoster
Cleared on Oct 26, 1992 after a 122-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 3 later devices descend from it. It has been recalled 2 times.
- Decided
- Oct 26, 1992
- Review
- 122 days
- Class
- Class II
- Product code
- LFY
- Recalls
- 2
- Predicates
- 0
3 later devices descend from it, 1 citing it directly.
- This deviceK923122 Vitek Immunodiagnostic Assay SystemBiomerieux Vitek, Inc. · 1992
- Descendant · cites it directly · 2 of its ownK091616 Bioplex 2200 MMRV IggBio-Rad Laboratories · 2010
- Descendant · 2 generations on · 0 of its ownK212769 DYNEX SmartPLEX MMRV IgG Assay KitDynex Technologies, Inc. · 2023
- Descendant · 2 generations on · 0 of its ownK111072 Bioplex 2200 MMRV Igg IT on Bioplex 2200 Multi-Analyte Detection…Bio-Rad Laboratories · 2011
Most influential descendants
Showing 3 of 3 · See all- K091616Bioplex 2200 MMRV IggBio-Rad Laboratories · 2010 · cites it directly2descendants
- K212769DYNEX SmartPLEX MMRV IgG Assay KitDynex Technologies, Inc. · 2023 · 2 generations on0descendants
- K111072Bioplex 2200 MMRV Igg IT on Bioplex 2200 Multi-Analyte Detection System, Bioplex 2200…Bio-Rad Laboratories · 2011 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K923122 | Vitek Immunodiagnostic Assay System | Biomerieux Vitek, Inc. | 1992 | — |
| +1 | K091616 | Bioplex 2200 MMRV Igg | Bio-Rad Laboratories | 2010 | — |
| +2 | K212769 | DYNEX SmartPLEX MMRV IgG Assay Kit | Dynex Technologies, Inc. | 2023 | — |
| +2 | K111072 | Bioplex 2200 MMRV Igg IT on Bioplex 2200 Multi-Analyte Detection System… | Bio-Rad Laboratories | 2011 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2023 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in LFY? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new LFY device
- #1 K231214 LIAISON VZV IgG HT, LIAISON Control VZV IgG HTscore 6.8 · 3 generations · no Class I recall
What was it cleared against?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K091616 | Bioplex 2200 MMRV Igg | 2010 | 2 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Nov 9, 2022 | Class II | Z-0795-2023 | Storage | As the temperature and time out of range was exceeded, product performances cannot be guaranteed |
| Dec 10, 2019 | Class II | Z-1107-2020 | Unknown/Undetermined by firm | 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 result. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K091616 (Bio-Rad Laboratories, 2010) has gone furthest, with 2 descendants of its own.
How does its category compare?
All LFY devicesLFY Enzyme Linked Immunoabsorbent Assay, Varicella-Zoster: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · LFY
1in 2023
2026 to Oct 25, outlined.
Median 510(k) review, days · LFY
Too few LFY 510(k)s in any year since 2007 to give a median.
Recalls per year · LFY
1in 2022
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LFY
2in 2024
MAUDE reports naming product code LFY, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 2 | — | 0 | 0 |
| 2008 | 0 | — | 1 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 1 | — | 0 | 20 |
| 2016 | 0 | — | 0 | 2 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 2 |
| 2019 | 0 | — | 0 | 2 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 1 | 2 |
| 2023 | 1 | — | 0 | 1 |
| 2024 | 0 | — | 0 | 2 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
https://510kreport.com/device/K923122 · printed Nov 6, 2026
Cite this page
510(k) Report. “K923122: Vitek Immunodiagnostic Assay System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K923122
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026