510(k) K081338
K081338 is an FDA 510(k) premarket notification submitted by Roche Diagnostics for the device "ROCHE ELECSYS ANTI-CCP IMMUNOASSAY, ROCHE ELECSYS PRECICONTROL ANTI-CCP". The FDA issued a decision of Substantially Equivalent on September 11, 2008. The device falls under product code NHX (Antibodies, Anti-Cyclic Citrullinated Peptide (Ccp)), a Class II device regulated under 21 CFR 866.5775. Roche Diagnostics has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 11, 2008
- Date Received
- May 13, 2008
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Antibodies, Anti-Cyclic Citrullinated Peptide (Ccp)
- Device Class
- Class II
- Regulation Number
- 866.5775
- Review Panel
- IM
- Submission Type
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.