Insulin Autoantibody Kit
The Insulin Autoantibody Kit (product code OCN) is an immunology in vitro diagnostic device used for the semi-quantitative determination of insulin autoantibodies in human serum as an aid in the diagnosis of Type 1 diabetes mellitus (autoimmune-mediated diabetes) in patients who have not yet received insulin therapy. Detecting insulin autoantibodies is a marker for autoimmune beta-cell destruction. This device is FDA Class 2 under regulation 866.5660 in the Immunology specialty, requires 510(k) clearance, and is eligible for third-party review. It carries no implant or life-sustaining flags.
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Basic Information
- Product Code
- OCN
- Device Class
- FDA class 2
- Regulation Number
- 866.5660
- Medical Specialty
- Immunology
- Review Panel
- IM
- Submission Type
- 1
Device Characteristics
Definition
The device is used for the semi-quantitative determination of insulin autoantibodies in human serum as an aid in the diagnosis of Type 1 diabetes mellitus (autoimmune mediated diabetes) in patients who have not received insulin therapy.
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 1 510(k) clearance via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K070183 | KRONUS INSULIN AUTOANTIBODY (IAA) ASSAY KIT | Jul 13, 2007 | Substantially Equivalent | Kronus Market Development Associates, Inc. |
FEI Numbers
This FDA classification entry is associated with 5 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 5 registration numbers. Click on an entry to view related FDA registrations.