LogoFDA 510(k) Search
K Number
K021192
Device Name
QACA IGG/IGM ELISA KIT HRP
Manufacturer
CHESHIRE DIAGNOSTICS LTD.
Date Cleared
2002-05-16

(31 days)

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

The Cheshire Diagnostics Limited QACA IgG/IgM Elisa Kit HRP is an Enzyme Linked Immunoassay for the in vitro semiquantitative detection of IgG and/or IgM antibodies to cardiolipin in human serum. The presence of cardiolipin antibodies can be used in conjunction with other serological tests and clinical findings to aid in the assessment of the risk from thrombosis for individuals diagnosed with Systemic Lupus Erythematosus (SLE) or other lupus-like disorders.

Device Description

Enzyme Linked Immunoassay for the in vitro semiquantitative detection of IgG and/or IgM antibodies to cardiolipin in human serum.

AI/ML Overview

The provided document is a 510(k) premarket notification letter from the FDA for a diagnostic kit, not a study report detailing acceptance criteria or device performance data. Therefore, the requested information (acceptance criteria, study details, sample sizes, ground truth establishment, expert qualifications, adjudication methods, MRMC studies, or standalone performance) is not present in the provided text.

The document does contain:

  • Device Name: QACA IgG/IgM Elisa Kit HRP
  • Intended Use: An Enzyme Linked Immunoassay for the in vitro semiquantitative detection of IgG and/or IgM antibodies to cardiolipin in human serum.
  • Clinical Application: To be used in conjunction with other serological tests and clinical findings to aid in the assessment of the risk from thrombosis for individuals diagnosed with Systemic Lupus Erythematosus (SLE) or other lupus-like disorders.
  • Regulatory Information: Class II device, Product Code MID, Regulation Number 21 CFR 866.5660.

To answer your specific questions, a detailed study report or clinical trial summary for the "QACA IgG/IgM Elisa Kit HRP" would be required. This document only confirms the FDA's clearance of the device for marketing based on substantial equivalence to a predicate device.

§ 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).