510(k) K063347
K063347 is an FDA 510(k) premarket notification submitted by Axis-Shield Diagnostics, Ltd. for the device "AXSYM ANTI-CCP REAGENT, STANDARD CALIBRATOR AND CONTROL KITS, MODELS 3L91-20, 3L91-01 AND 3L91-10". The FDA issued a decision of Substantially Equivalent on March 20, 2007. The device falls under product code NHX (Antibodies, Anti-Cyclic Citrullinated Peptide (Ccp)), a Class II device regulated under 21 CFR 866.5775. Axis-Shield Diagnostics, Ltd. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 20, 2007
- Date Received
- November 6, 2006
- 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.