K110296 is an FDA 510(k) clearance for the AXIS-SHIELD ANTI-CCP. This device is classified as a Antibodies, Anti-cyclic Citrullinated Peptide (ccp) (Class II - Special Controls, product code NHX).
Submitted by Axis-Shield Diagnostics, Ltd. (Dundee, Scotland, GB). The FDA issued a Cleared decision on August 18, 2011, 198 days after receiving the submission on February 1, 2011.
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 | K110296 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 01, 2011 |
| Decision Date | August 18, 2011 |
| Days to Decision | 198 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. |