Kronus IA-2 Autoantibody RIA Assay Kit
by Kronus Market Development Associates, Inc.
510(k) K073590
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK073590 | Date10 Apr 2008 | StatusActive |
Recalls
No FDA recalls found in the data synced 6 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- OIF
- Device Class
- Class II
- Regulation
- 21 CFR Part 866.5660
- Advisory Committee
- Immunology
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 1 Oct 2026
The Kronus IA-2 Autoantibody RIA Assay Kit is a Tyrosine Phosphatase (IA-2) Autoantibody Assay, designed for the semi-quantitative detection of autoantibodies to IA-2 in human serum. This immunoassay falls under the category of radioligand assays and is classified as a Class II medical device under FDA regulations. It aids in identifying markers associated with autoimmune processes, specifically targeting IA-2, a key antigen linked to Type 1 diabetes mellitus.
This assay kit is intended for use in clinical laboratory settings and requires specialized handling, including radioligand techniques. Supplied as a single-use diagnostic tool, it is not intended for reuse and must be stored and handled according to radiolabeling safety protocols. The device holds an FDA 510(k) clearance (K073590) under the Immunology advisory committee, adhering to regulatory standards for diagnostic immunoassays. No MRI safety or sterility claims are specified in the data.
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Questions
AI-generated answers, 1 Oct 2026
What is the Kronus IA-2 Autoantibody RIA Assay Kit used for?
This assay kit is designed for the semi-quantitative detection of autoantibodies to IA-2 (Tyrosine Phosphatase) in human serum. IA-2 is a key antigen associated with autoimmune processes, particularly Type 1 diabetes mellitus. By identifying these markers, clinicians can better assess autoimmune risk in patients.
How is the Kronus IA-2 Autoantibody RIA Assay Kit supplied and intended for use?
The kit is supplied as a single-use diagnostic tool and is intended exclusively for use in clinical laboratory settings. It requires specialized handling, including radioligand techniques, due to its classification as a radioligand assay. It is not intended for reuse or patient-side use outside of controlled lab environments.
Is sterility or MRI safety applicable to this assay kit?
The provided data does not specify any claims related to sterility or MRI safety for this assay kit. It is a radioligand-based diagnostic tool and must be handled according to radiolabeling safety protocols, not as a sterile or MRI-compatible device.
What regulatory clearance does the Kronus IA-2 Autoantibody RIA Assay Kit hold?
The kit holds an FDA 510(k) clearance (K073590) under the Immunology advisory committee, classified as substantially equivalent to a predicate device. This clearance was granted in 2008 and is specific to its use as a diagnostic immunoassay for detecting IA-2 autoantibodies.
How should the Kronus IA-2 Autoantibody RIA Assay Kit be stored?
While specific storage instructions are not detailed in the provided data, the kit must be stored and handled according to radiolabeling safety protocols due to its radioligand components. This includes proper shielding, containment, and disposal procedures to ensure safety and compliance with regulatory standards for radioactive materials.