K081248 is an FDA 510(k) clearance for the QUANTA LITE OMP PLUS ELISA. This device is classified as a Antibodies, Outer-membrane Proteins (Class II - Special Controls, product code OKM).
Submitted by Inova Diagnostics, Inc. (San Diego, US). The FDA issued a Cleared decision on October 27, 2008, 178 days after receiving the submission on May 2, 2008.
This device falls under the Immunology FDA review panel. Regulated under 21 CFR 866.5785. For The Detection Of Anti-outer Membrane Protein (anti-omp) Antibodies In Human Serum. To Aid In The Diagnosis Of Crohn's Disease..
| 510(k) Number | K081248 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 02, 2008 |
| Decision Date | October 27, 2008 |
| Days to Decision | 178 days |
| Submission Type | Traditional |
| Review Panel | Immunology (IM) |
| Summary | Statement |
| Product Code | OKM — Antibodies, Outer-membrane Proteins |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 866.5785 |
| Definition | For The Detection Of Anti-outer Membrane Protein (anti-omp) Antibodies In Human Serum. To Aid In The Diagnosis Of Crohn's Disease. |