# K081248: Quanta Lite Omp Plus Elisa

- Pathway: 510(k) (Traditional)
- Applicant: Inova Diagnostics, Inc.
- Decided: Oct 27, 2008 after 178 days
- Product code: OKM (Antibodies, Outer-Membrane Proteins)
- Device class: 2
- Regulation: 21 CFR 866.5785
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
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.

Source page: https://510kreport.com/device/K081248
Methodology: https://510kreport.com/methodology