510(k) · Cleared
ClearedAnti-Mutated Citrullinated Vimentin Eia
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Orgentec Diagnostika GmbH · OQZ Anti-Mutated Citrullinated Vimentin Igg
Cleared on Jul 1, 2010 as substantially equivalent to K052133 (Eurodiagnostica, 2005) after a 329-day review. Its family tree reaches back 1 generation to 2005.
- Decided
- Jul 1, 2010
- Review
- 329 days
- Class
- Class II
- Product code
- OQZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K052133 (2005). No later device cites it as a predicate yet.
- Root · 1 generation backK052133 Immunoscan RA Anti-CCP Test SystemEurodiagnostica · 2005
- This deviceK092399 Anti-Mutated Citrullinated Vimentin EiaOrgentec Diagnostika GmbH · 2010
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K052133 | Immunoscan RA Anti-CCP Test System | Eurodiagnostica | 2005 | — |
| 0 (this device) | K092399 | Anti-Mutated Citrullinated Vimentin Eia | Orgentec Diagnostika GmbH | 2010 | — |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in OQZ? 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? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K052133 | Immunoscan RA Anti-CCP Test System | 2005 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Its one ancestor has no recall.
- 3 other devices also cite its predicate K052133.
How does its category compare?
All OQZ devicesOQZ Anti-Mutated Citrullinated Vimentin Igg: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, this device’s year, is highlighted.
FDA decisions per year · OQZ
1in 2010
2026 to Oct 25, outlined.
Median 510(k) review, days · OQZ
Too few OQZ 510(k)s in any year since 2007 to give a median.
Recalls per year · OQZ
No recall names OQZ since 2007.
Adverse event reports per year · OQZ
No MAUDE report names OQZ since 2007.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 1 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
Anti-MCV®D is an indirect solid phase enzyme immunoassay (ELISA) for the qualitative and semi-quantitative measurement of IgO crass auto antibodies against mutated citrullinated vimentin (MCV) in human serum. The assay is intended for in vitro diagnostic use only as an aid in the diagnosis of Rheumatoid Arthritis in conjunction with other laboratory and clinical findings.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K092399 · printed Nov 6, 2026
Cite this page
510(k) Report. “K092399: Anti-Mutated Citrullinated Vimentin Eia.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K092399
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026