510(k) K111956
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 30, 2012
- Date Received
- July 11, 2011
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Voltage Gated Calcium Channel (Vgcc) Antibody Assay
- Device Class
- Class II
- Regulation Number
- 866.5660
- Review Panel
- IM
- Submission Type
Intended for semi-quantitative determination of VGCC Antibody in human serum. The VGCC Ab may be present in patients diagnosed with Lambert-Eaton Syndrome (LEMS). The assay result is not to be used alone and to be used in conjunction with other clinical, electrodiagnostic and laboratory findings.