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K Number
K972790
Device Name
THE THERATEST EL-B2GP1 (IGM, IGG, IGA) AND EL-B2GP1SCR
Manufacturer
THERATEST LABORATORIES, INC.
Date Cleared
1997-12-05

(130 days)

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

The TheraTest EL-B2GP1 (IgM, IgG, IgA) is an in vitro diagnostic tests for the measurement of IgM, IgG and IgA vito and homan serum directed against the serum glycoprotein Beta 2 Glycoprotein 1 (82GP1) . This measurement aids in the diagnosis of antiphospholipid antibody syndrome (APS) or certain autoimmune thrombotic disorders such as those secondary to systemic lupus erythematosus.

Device Description

Not Found

AI/ML Overview

I am sorry, but the provided text does not contain the acceptance criteria or a study that proves the device meets any specific criteria. The document is a 510(k) clearance letter from the FDA for the TheraTest EL-B2GP1 (IgM, IgG, IgA) device, indicating that it has been deemed "substantially equivalent" to a legally marketed predicate device.

The letter explicitly states:

  • "We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976..."

This means the FDA reviewed the premarket notification based on substantial equivalence, not on the basis of new clinical study acceptance criteria or performance metrics directly demonstrating independent efficacy or accuracy as would be presented in a clinical trial report.

Therefore, I cannot provide a table of acceptance criteria, reported device performance, information on sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set details from the provided text.

§ 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).