510(k) K060431
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 19, 2006
- Date Received
- February 21, 2006
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Autoantibodies, Anti-Ribonucleic Acid Polymerase (Rnap) Iii Antibody
- Device Class
- Class II
- Regulation Number
- 866.5100
- Review Panel
- IM
- Submission Type
The anti-rna polymerase iii test is a semi-quantitative elisa for the detection of anti-rna polymerase iii antibodies in human serum. The test result is used as an aid in the diagnosis of systemic sclerosis (ssc) in conjunction with the clinical and other laboratory findings. For in-vitro diagnostic use.