K021516 is an FDA 510(k) clearance for the DIASTAT ANTI CYCLIC CITRULLINATED PEPTIDE ELISA, MODEL FCCP 200. 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 July 23, 2002, 74 days after receiving the submission on May 10, 2002.
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 | K021516 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 10, 2002 |
| Decision Date | July 23, 2002 |
| Days to Decision | 74 days |
| Submission Type | Traditional |
| Review Panel | Immunology (IM) |
| Summary | Statement |
| 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. |