510(k) K172078
K172078 is an FDA 510(k) premarket notification submitted by Immco Diagnostics, Inc. for the device "ImmuLisa Enhanced RNA POL III Antibody ELISA". The FDA issued a decision of Substantially Equivalent on March 30, 2018. 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. Immco Diagnostics, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 30, 2018
- Date Received
- July 10, 2017
- 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.