K143754 is an FDA 510(k) clearance for the QUANTA Flash CCP3, QUANTA Flash CCP3 Calibrators, and QUANTA Flash CCP3. This device is classified as a Antibodies, Anti-cyclic Citrullinated Peptide (ccp) (Class II - Special Controls, product code NHX).
Submitted by Inova Diagnostics, Inc. (San Diego, US). The FDA issued a Cleared decision on September 21, 2015, 264 days after receiving the submission on December 31, 2014.
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 | K143754 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 31, 2014 |
| Decision Date | September 21, 2015 |
| Days to Decision | 264 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. |