K081338 is an FDA 510(k) clearance for the ROCHE ELECSYS ANTI-CCP IMMUNOASSAY, ROCHE ELECSYS PRECICONTROL ANTI-CCP. This device is classified as a Antibodies, Anti-cyclic Citrullinated Peptide (ccp) (Class II - Special Controls, product code NHX).
Submitted by Roche Diagnostics (Indianapolis, US). The FDA issued a Cleared decision on September 11, 2008, 121 days after receiving the submission on May 13, 2008.
This device falls under the Immunology FDA review panel. Regulated under 21 CFR 866.5775. The Device Is Used For The Detection Of Anti-cyclic Citrullinated Peptide (ccp) Antibodies In Human Serum Or Plasma As An Aid In The Diagnosis Of Rheumatoid Arthritis..
| 510(k) Number | K081338 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 13, 2008 |
| Decision Date | September 11, 2008 |
| Days to Decision | 121 days |
| Submission Type | Traditional |
| Review Panel | Immunology (IM) |
| Summary | Summary PDF |
| Product Code | NHX — Antibodies, Anti-cyclic Citrullinated Peptide (ccp) |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 866.5775 |
| Definition | The Device Is Used For The Detection Of Anti-cyclic Citrullinated Peptide (ccp) Antibodies In Human Serum Or Plasma As An Aid In The Diagnosis Of Rheumatoid Arthritis. |