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K Number
K171731
Device Name
KRONUS IA-2 Autoantibody (IA-2Ab) ELISA Kit
Manufacturer
Kronus, Inc.
Date Cleared
2018-01-19

(221 days)

Product Code
OIF
Regulation Number
866.5660
Type
Traditional
Panel
CH
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

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.

Device Description

Not Found

AI/ML Overview

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.

§ 866.5660 Multiple autoantibodies immunological test system.

(a)
Identification. A multiple autoantibodies immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the autoantibodies (antibodies produced against the body's own tissues) in serum and other body fluids. Measurement of multiple autoantibodies aids in the diagnosis of autoimmune disorders (disease produced when the body's own tissues are injured by autoantibodies).(b)
Classification. Class II (performance standards).