510(k) K060431
K060431 is an FDA 510(k) premarket notification submitted by Mbl International Corporation for the device "ANTI RNA POLYMERASE III ELISA KIT, MODEL 7805". The FDA issued a decision of Substantially Equivalent on June 19, 2006. The device falls under product code NYO (Autoantibodies, Anti-Ribonucleic Acid Polymerase (Rnap) Iii Antibody), a Class II device regulated under 21 CFR 866.5100. Mbl International Corporation has at least 1 other 510(k) clearance on record.
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.