510(k) · Cleared
ClearedQuanta Lite Omp Plus Elisa
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Inova Diagnostics, Inc. · OKM Antibodies, Outer-Membrane Proteins
Cleared on Oct 27, 2008 after a 178-day review. FDA’s file for it is a 510(k) statement, which names no predicate.
- Decided
- Oct 27, 2008
- Review
- 178 days
- Class
- Class II
- Product code
- OKM
- Recalls
- None
- Predicates
- 0
FDA’s file for it is a 510(k) statement, which names no predicate.
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in OKM? 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’s file for it is a 510(k) statement, which names no predicate.
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.
How does its category compare?
All OKM devicesOKM Antibodies, Outer-Membrane Proteins: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, this device’s year, is highlighted.
FDA decisions per year · OKM
1in 2008
2026 to Oct 25, outlined.
Median 510(k) review, days · OKM
Too few OKM 510(k)s in any year since 2007 to give a median.
Recalls per year · OKM
No recall names OKM since 2007.
Adverse event reports per year · OKM
No MAUDE report names OKM 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 | 1 | — | 0 | 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 | 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?
The QUANTA LiteTM OMP Plus kit is an enzyme-linked immunosorbent assay (ELISA) for the semi-quantitative detection of anti-OMP antibodies of the IgA class in human serum. It is intended to be used in conjunction with anti-Saccharomycescerevisiae (S. cerevisiae) antibody (ASCA) IgG and/or IgA test systems. The presence of OMP (outer membrane proteins) IgA antibodies, used in conjunction with clinical findings and other laboratory tests, may aid in the diagnosis of patients with Crohn's disease.
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K081248 · printed Nov 5, 2026
Cite this page
510(k) Report. “K081248: Quanta Lite Omp Plus Elisa.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K081248
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Page last updated Nov 3, 2026