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K Number
K983418
Device Name
THE APTUS(AUTOMATED)APPLICATION OF THE RHEUMATOID FACTOR IGM ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY(EL
Manufacturer
ZEUS SCIENTIFIC, INC.
Date Cleared
1998-11-18

(50 days)

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

The Zeus Scientific, Inc. Rheumatoid Factor IgM ELISA test system is intended for the qualitative and semi-quantitative detection of RF IgM class antibody in human serum. The test system is intended for the manual or automated analysis of human serum for the presence of IgM RF. The test system is intended to be used as aid in the diagnosis of rheumatoid arthritis. The test is for in vitro diagnostic use.

Device Description

Not Found

AI/ML Overview

I am sorry, but the provided text does not contain information about the acceptance criteria, device performance, or any studies conducted to prove the device meets acceptance criteria. The document is an FDA 510(k) clearance letter for the "Aptus (Automated) Application for the RF Test System" (Rheumatoid Factor IgM ELISA Test System), indicating that it has been found substantially equivalent to a legally marketed predicate device.

The text does include the following:

  • Device Name: Aptus (Automated) Application for the Rheumatoid Factor IgM ELISA Test System
  • Indications for Use: The Zeus Scientific, Inc. Rheumatoid Factor IgM ELISA test system is intended for the qualitative and semi-quantitative detection of RF IgM class antibody in human serum. The test system is intended for the manual or automated analysis of human serum for the presence of IgM RF. The test system is intended to be used as aid in the diagnosis of rheumatoid arthritis. The test is for in vitro diagnostic use.
  • Regulatory Class: II
  • Product Code: DHR
  • Application Date: September 28, 1998
  • Received Date: September 29, 1998
  • Clearance Date: November 18, 1998

To answer your specific questions, information regarding acceptance criteria, device performance, study details (sample sizes, provenance, ground truth, expert qualifications, adjudication methods, MRMC studies, standalone performance, training set details) would typically be found in the 510(k) summary or the full 510(k) submission, neither of which is present in the provided text.

§ 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).