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K Number
K051061
Device Name
KRONUS GLUTAMIC ACID DECARBOXYLASE ANTIBODY KIT
Manufacturer
KRONUS MARKET DEVELOPMENT ASSOCIATES, INC.
Date Cleared
2005-11-04

(192 days)

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

The KRONUS GADAb RIA Assay Kit is for the semi-quantitative determination of glutamic acid decarboxylase antibody in human serum. The KRONUS GADAb RIA Assay is useful as an aid in the diagnosis of Type I diabetes mellitus (autoimmune mediated diabetes).

Device Description

KRONUS Glutamic Acid Decarboxylase (GADAb) RIA Assay Kit

AI/ML Overview

The provided text is related to a 510(k) premarket notification for a medical device called the "KRONUS Glutamic Acid Decarboxylase (GADAb) RIA Assay Kit." This document is a clearance letter from the FDA, indicating that the device has been deemed substantially equivalent to a legally marketed predicate device.

However, the document does not contain the detailed information required to describe the acceptance criteria and the study that proves the device meets the acceptance criteria as requested in your prompt.

Specifically, the document does not include:

  • A table of acceptance criteria and reported device performance.
  • Sample sizes used for the test set or data provenance.
  • Number of experts or their qualifications, or adjudication methods for ground truth.
  • Information about MRMC comparative effectiveness studies or effect sizes.
  • Details on standalone algorithm performance.
  • The type of ground truth used (e.g., pathology, outcomes data).
  • Sample size for the training set or how ground truth was established for the training set.

The document is a clearance letter and focuses on the regulatory aspects of the FDA's decision, rather than the scientific and statistical details of the performance study. To get the requested information, one would typically need to review the actual 510(k) submission document or the device's Instructions for Use (IFU) or package insert, which would contain the performance study details.

§ 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).