510(k) · Cleared
Recalled · Class II · 2022Vidas CMV Igm Assay
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Biomerieux Vitek, Inc. · LKQ Antibody Igm,If, Cytomegalovirus Virus
Cleared on Aug 2, 1994 after a 376-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
- Aug 2, 1994
- Review
- 376 days
- Class
- Class II
- Product code
- LKQ
- Recalls
- 2
- Predicates
- 0
3 later devices descend from it, 2 citing it directly.
- This deviceK933549 Vidas CMV Igm AssayBiomerieux Vitek, Inc. · 1994
- Descendant · cites it directly · 1 of its ownK092587 Bioplex 2200 Rubella & CMV Igm Kit on the Bioplex 2200 Multi Analyte…Bio-Rad Laboratories · 2010
- Descendant · 2 generations on · 0 of its ownK170509 BioPlex 2200 ToRC IgM, BioPlex 2200 ToRC IgM Calibrator Set, BioPlex…Bio-Rad Laboratories · 2017
- Descendant · cites it directly · 0 of its ownK100433 Immulite 2000 CMV Igm, Immulite CMV Igm Controls, and Immulite 200…Siemens Healthcare Diagnostics · 2010 · Recalled
Most influential descendants
Showing 3 of 3 · See all- K092587Bioplex 2200 Rubella & CMV Igm Kit on the Bioplex 2200 Multi Analyte Detection SystemBio-Rad Laboratories · 2010 · cites it directly1descendant
- K170509BioPlex 2200 ToRC IgM, BioPlex 2200 ToRC IgM Calibrator Set, BioPlex 2200 ToRC IgM…Bio-Rad Laboratories · 2017 · 2 generations on0descendants
- K100433Immulite 2000 CMV Igm, Immulite CMV Igm Controls, and Immulite 200 CMV Igm Adjustor…Siemens Healthcare Diagnostics · 2010 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K933549 | Vidas CMV Igm Assay | Biomerieux Vitek, Inc. | 1994 | — |
| +1 | K092587 | Bioplex 2200 Rubella & CMV Igm Kit on the Bioplex 2200 Multi Analyte Detection… | Bio-Rad Laboratories | 2010 | — |
| +2 | K170509 | BioPlex 2200 ToRC IgM, BioPlex 2200 ToRC IgM Calibrator Set, BioPlex 2200 ToRC… | Bio-Rad Laboratories | 2017 | — |
| +1 | K100433 | Immulite 2000 CMV Igm, Immulite CMV Igm Controls, and Immulite 200 CMV Igm… | Siemens Healthcare Diagnostics | 2010 | 2 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 2 | 0 |
| 2017 | 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 LKQ? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
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)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Feb 9, 2022 | Class II | Z-0742-2022 | Nonconforming Material/Component | Invalid calibrations (out of range high) while using the product. |
| Mar 16, 2021 | Class II | Z-1408-2021 | Under Investigation by firm | bioMerieux received complaints about calibration issue observed on several lots of VIDAS¿ CMV IgM (ref 30205 ; 30205-01). |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K092587 (Bio-Rad Laboratories, 2010) has gone furthest, with 1 descendant of its own.
How does its category compare?
All LKQ devicesLKQ Antibody Igm,If, Cytomegalovirus Virus: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · LKQ
1in 2010
2026 to Oct 25, outlined.
Median 510(k) review, days · LKQ
Too few LKQ 510(k)s in any year since 2007 to give a median.
Recalls per year · LKQ
1in 2022
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LKQ
17in 2022
MAUDE reports naming product code LKQ, 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 | 0 | — | 1 | 1 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 1 | — | 1 | 3 |
| 2011 | 0 | — | 0 | 5 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 2 |
| 2016 | 0 | — | 2 | 29 |
| 2017 | 0 | — | 0 | 14 |
| 2018 | 0 | — | 0 | 8 |
| 2019 | 0 | — | 0 | 9 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 68 |
| 2022 | 0 | — | 1 | 17 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
https://510kreport.com/device/K933549 · printed Nov 6, 2026
Cite this page
510(k) Report. “K933549: Vidas CMV Igm Assay.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K933549
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026