K153551 is an FDA 510(k) clearance for the ADVIA Centaur Anti-CCP IgG (aCCP) assay including Reagents and Calibrators, Quality Controls and Master Curve Materials.. This device is classified as a Antibodies, Anti-cyclic Citrullinated Peptide (ccp) (Class II - Special Controls, product code NHX).
Submitted by Axis-Shield Diagnostics Limited (Dundee, GB). The FDA issued a Cleared decision on August 4, 2016, 237 days after receiving the submission on December 11, 2015.
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 | K153551 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 11, 2015 |
| Decision Date | August 04, 2016 |
| Days to Decision | 237 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. |