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K Number
K994338
Device Name
AUTOSTAT II RHEUMATOID FACTOR IGM ELISA
Manufacturer
COGENT DIAGNOTICS LTD.
Date Cleared
2000-02-03

(42 days)

Product Code
DHR
Regulation Number
866.5775
Type
Traditional
Panel
IM
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

ENZAME LINKED IMMUNDSOKERAT ASSIM METHOD FOR THE SOMI - QUATITATUE DEFERENTIAN ATTON OF SFECIFIC IGM RHEUMATOLD FACTOR (RF) ANTIES DIES IN HUMAN SEBENA. USES: THE RESULTS OF THE REIGM ASSAY CAN BE USED AS AN AID IN THE DIRENCES & RHERMATORD ARTHRITIS CRA) WHEN SUPPORTED BY OTHER CABORATORY AND CUMCAL INVESTIGATIONS . LEVELS OF THESE AUTOANTIES ARE ONE ONE MINICATION IN A MUTIFACTORIAL DIAGNOSTIC GIME. THE ASSAY MAT BE USED ON THE HAUSE HYOTEC AUTOMATED EIA INSTRUMENT. FOR IN UTRO DIAGNOSIAC USE CAULY

Device Description

Not Found

AI/ML Overview

I am sorry, but the provided text does not contain the detailed information necessary to describe the acceptance criteria and the study that proves the device meets them, as requested. The document is an FDA 510(k) clearance letter for the "Autostat™ II Rheumatoid Factor IgM ELISA" device, indicating that it has been deemed substantially equivalent to a legally marketed predicate device.

The letter does not include:

  • A table of acceptance criteria or reported device performance.
  • Details about the sample size, data provenance, number of experts, adjudication methods for ground truth, or qualifications of experts.
  • Information on multi-reader multi-case (MRMC) comparative effectiveness studies.
  • Details about standalone algorithm performance studies.
  • The type of ground truth used for any studies.
  • Information about the training set size or how its ground truth was established.

The document only states the device's trade name, regulatory class, product code, and its intended use: "ENZYME LINKED IMMUNOSORBENT ASSAY METHOD FOR THE SEMI-QUANTITATIVE DETERMINATION OF SPECIFIC IGM RHEUMATOID FACTOR (RF) ANTIBODIES IN HUMAN SERA. USES: THE RESULTS OF THE RF IGM ASSAY CAN BE USED AS AN AID IN THE DIAGNOSIS OF RHEUMATOID ARTHRITIS (RA) WHEN SUPPORTED BY OTHER LABORATORY AND CLINICAL INVESTIGATIONS. LEVELS OF THESE AUTOANTIBODIES ARE ONE INDICATION IN A MULTIFACTORIAL DIAGNOSTIC SCHEME. THE ASSAY MAY BE USED ON THE HAAKE HYPOTEC AUTOMATED EIA INSTRUMENT. FOR IN VITRO DIAGNOSTIC USE ONLY."

§ 866.5775 Rheumatoid factor immunological test system.

(a)
Identification. A rheumatoid factor immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the rheumatoid factor (antibodies to immunoglobulins) in serum, other body fluids, and tissues. Measurement of rheumatoid factor may aid in the diagnosis of rheumatoid arthritis.(b)
Classification. Class II (performance standards).