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K Number
K042241
Device Name
K-ASSAY TOTAL IGE, K-ASSAY IGE CALIBRATOR SET, MODELS KAI-092/KAI-093C
Manufacturer
KAMIYA BIOMEDICAL CO.
Date Cleared
2004-12-10

(113 days)

Product Code
DGC,JIT
Regulation Number
866.5510
Type
Traditional
Panel
IM
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The Kamiya K-ASSAY® Total IgE is an in vitro diagnostic reagent for the quantitative determination of circulating total IgE in human serum or plasma by immunoturbidimetric assay for use as an aid in the clinical diagnosis of IgE mediated allergic disorders in conjunction with other clinical findings.

The K-ASSAY® IgE Calibrator Set is an in vitro diagnostic reagent for the calibration of the K-ASSAY® Total IgE Assay.

For in vitro diagnostic use.

Device Description

Not Found

AI/ML Overview

The provided document is a 510(k) premarket notification letter from the FDA for a medical device called "K-Assay® Total IgE Assay" and "K-Assay® IgE Calibrator." This document primarily communicates the FDA's decision that the device is substantially equivalent to legally marketed predicate devices.

It does NOT contain the detailed information necessary to answer your request about acceptance criteria and a study proving the device meets those criteria.

Specifically, the document does not include:

  • A table of acceptance criteria and reported device performance.
  • Sample sizes for test sets, data provenance, or details about training sets.
  • Information on expert ground truth establishment (number, qualifications, adjudication method).
  • Details on Multi-Reader Multi-Case (MRMC) comparative effectiveness studies or standalone algorithm performance.
  • The type of ground truth used.

This type of information would typically be found in the device's original 510(k) submission, specifically in the performance study sections, which are not included in this FDA decision letter. The letter confirms clearance but does not provide the underlying study data.

§ 866.5510 Immunoglobulins A, G, M, D, and E immunological test system.

(a)
Identification. An immunoglobulins A, G, M, D, and E immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the immunoglobulins A, G, M, D, an E (serum antibodies) in serum. Measurement of these immunoglobulins aids in the diagnosis of abnormal protein metabolism and the body's lack of ability to resist infectious agents.(b)
Classification. Class II (performance standards).