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.
| Device Type ID | 3061 |
| Device Name | Antibodies, Anti-cyclic Citrullinated Peptide (ccp) |
| Regulation Description | Rheumatoid Factor Immunological Test System. |
| Regulation Medical Specialty | Immunology |
| Review Panel | Immunology |
| Premarket Review | Office Of In Vitro Diagnostics And Radiological Health (OIR) |
| Submission Type | 510(k) |
| CFR Regulation Number | 866.5775 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | NHX |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 3061 |
| Device | Antibodies, Anti-cyclic Citrullinated Peptide (ccp) |
| Product Code | NHX |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Rheumatoid Factor Immunological Test System. |
| CFR Regulation Number | 866.5775 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
INOVA DIAGNOSTICS, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
| Device Problems | |
|---|---|
High Test Results | 10 |
Incorrect, Inadequate Or Imprecise Result Or Readings | 1 |
| Total Device Problems | 11 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Euro Diagnostica AB | II | Aug-23-2018 |
| 2 | Phadia US Inc | II | Feb-24-2017 |