510(k) K220085
K220085 is an FDA 510(k) premarket notification submitted by Kronus, Inc. for the device "KRONUS IA-2 Autoantibody (IA-2Ab) ELISA Kit". The FDA issued a decision of Substantially Equivalent on August 24, 2023. The device falls under product code OIF (Tyrosine Phosphatase (Ia-2) Autoantibody Assay), a Class II device regulated under 21 CFR 866.5660. Kronus, Inc. has at least 8 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 24, 2023
- Date Received
- January 11, 2022
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Tyrosine Phosphatase (Ia-2) Autoantibody Assay
- Device Class
- Class II
- Regulation Number
- 866.5660
- Review Panel
- IM
- Submission Type
The device is used for the semi-quantitative determination of autoantibodies against tyrosine phosphatase (IA-2) in human serum as an aid in the diagnosis of Type 1 diabetes mellitus (autoimmune mediated diabetes).