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The KRONUS IA-2 Autoantibody (IA-2Ab) ELISA Kit is for the qualitative determination of antibodies to Islet Antigen-2 (IA-2) in human serum. The KRONUS IA-2 Autoantibody (IA-2Ab) ELISA Kit may be useful as an aid in the diagnosis of Type 1 diabetes mellitus (autoimmune mediated diabetes). The KRONUS IA-2 Autoantibody (IA-2Ab) ELISA Kit is not to be used alone and is to be used in conjunction with other clinical and laboratory findings.

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This document is an FDA clearance letter for an in vitro diagnostic (IVD) device, specifically an ELISA kit. It does not contain information about an AI/ML-driven medical device study or its performance characteristics. Thus, most of the requested information regarding acceptance criteria, study design, ground truth establishment, and expert involvement for an AI medical device cannot be extracted from this document.

The document discusses the clearance of the KRONUS IA-2 Autoantibody (IA-2Ab) ELISA Kit (K220085) for the qualitative determination of antibodies to Islet Antigen-2 (IA-2) in human serum, to be used as an aid in the diagnosis of Type 1 diabetes mellitus.

Therefore, I cannot provide the requested information based on the provided text. The questions are specifically tailored for an AI/ML device study, not for an ELISA kit's regulatory clearance.

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The KRONUS IA-2 Autoantibody (IA-2Ab) ELISA Kit is for the quantitative determination of antibodies to Islet Antigen-2 (IA-2) in human serum. The KRONUS IA-2 Autoantibody (IA-2Ab) ELISA Kit may be useful as an aid in the diagnosis of Type 1 diabetes mellitus (autoimmune mediated diabetes). The KRONUS IA-2 Autoantibody (IA-2Ab) ELISA Kit is not to be used alone and is to be used in conjunction with other clinical and laboratory findings.

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The provided text is an FDA 510(k) clearance letter for the KRONUS IA-2 Autoantibody (IA-2Ab) ELISA Kit. This letter confirms that the device has been reviewed and determined to be substantially equivalent to legally marketed predicate devices.

However, the letter does not contain any information about the acceptance criteria, study design, or performance data for the KRONUS IA-2 Autoantibody (IA-2Ab) ELISA Kit. It merely states the device's indications for use and general regulatory information.

Therefore, I cannot provide the requested information, including:

1. A table of acceptance criteria and reported device performance.
2. Sample sizes used for test sets or data provenance.
3. Number of experts or their qualifications for ground truth establishment.
4. Adjudication method.
5. Information on multi-reader multi-case (MRMC) comparative effectiveness studies.
6. Information on standalone (algorithm only) performance studies.
7. The type of ground truth used.
8. The sample size for the training set.
9. How ground truth for the training set was established.

This type of detailed study information is typically found in the 510(k) submission itself (which is not provided here) or in accompanying technical documentation or scientific publications, not in the clearance letter. The letter is the outcome of the review process, not the detailed report of the review findings.

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