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K Number
K991801
Device Name
BINDAZYME ANTI-B2 GP1 IGG EIA TEST KIT
Manufacturer
THE BINDING SITE, LTD.
Date Cleared
2000-05-05

(345 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

For the in-vitro measurement for of IgG autoantibodies against B2-glycoprotein 1 (B2GP1) present in human serum. This kit may be used in conjunction with anticardiolipin assays and clinical information to aid the diagnosis of thrombosis in at risk patients having, for example, antiphospholipid syndrome (APS) or systemic lupus erythematosus (SLE).

Device Description

Not Found

AI/ML Overview

I am sorry, but based on the provided document, I cannot extract the detailed information required to describe the acceptance criteria and the study that proves the device meets those criteria. The document is a 510(k) clearance letter from the FDA, which confirms the substantial equivalence of the Bindazyme® Anti-B2 GP1 IgG EIA Test Kit to a predicate device for its stated indications for use.

While the document identifies the device and its intended use, it does not contain any information about:

  • Specific acceptance criteria (thresholds or metrics) for the device's performance.
  • Results of a study detailing performance metrics like sensitivity, specificity, accuracy, etc.
  • Sample sizes for test or training sets.
  • Data provenance.
  • Details about experts establishing ground truth or adjudication methods.
  • Whether MRMC or standalone studies were performed.
  • Types of ground truth used.

Essentially, this document is a regulatory approval notice, not a detailed technical report of a performance study. To answer your request, I would need a different type of document, such as a summary of safety and effectiveness, a clinical study report, or a comprehensive device manual that includes performance data.

§ 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).