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K Number
K030238
Device Name
BINDAZYME ANTI-MITOCHONDRIA M2 IGGAM EIA KIT
Manufacturer
THE BINDING SITE, LTD.
Date Cleared
2003-03-24

(60 days)

Product Code
DBM
Regulation Number
866.5090
Type
Traditional
Panel
IM
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

This assay is intended for the in-vitro measurement of specific IgG, IgA and IgM autoantibodies against mitochondria present in human serum as an aid in the diagnosis of primary biliary cirrhosis (PBC) when used in conjunction with other clinical observations.

Device Description

BINDAZYME® Anti-Mitochondria M2 IgGAM EIA Kit

AI/ML Overview

The provided text describes a 510(k) premarket notification for the "BINDAZYME® Anti-Mitochondria M2 IgGAM EIA Kit." This document is a regulatory letter from the FDA determining substantial equivalence, and it does not contain the detailed study results, acceptance criteria, or performance data typically found in a clinical study report.

Therefore, I cannot extract the specific information requested about acceptance criteria, device performance, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth establishment.

The document primarily states:

  • Device Name: BINDAZYME® Anti-Mitochondria M2 IgGAM EIA Kit
  • Intended Use: "This assay is intended for the in-vitro measurement of specific IgG, IgA and IgM autoantibodies against mitochondria present in human serum as an aid in the diagnosis of primary biliary cirrhosis (PBC) when used in conjunction with other clinical observations."
  • Regulatory Status: Substantially equivalent to a legally marketed predicate device.
  • Product Code: DBM (Anti-mitochondrial antibody immunological test system)
  • Regulatory Class: Class II

To provide the information you requested, access to the actual 510(k) submission document or a clinical study report would be necessary.

§ 866.5090 Antimitochondrial antibody immunological test system.

(a)
Identification. An antimitochondrial antibody immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the antimitochondrial antibodies in human serum. The measurements aid in the diagnosis of diseases that produce a spectrum of autoantibodies (antibodies produced against the body's own tissue), such as primary biliary cirrhosis (degeneration of liver tissue) and chronic active hepatitis (inflammation of the liver).(b)
Classification. Class II (performance standards).