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K Number
K021610
Device Name
QAB2A IGM ELISA KIT HRP
Manufacturer
CHESHIRE DIAGNOSTICS LTD.
Date Cleared
2002-07-12

(57 days)

Product Code
MSV
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 QAß2A IgM Elisa Kit HRP is an Enzyme Linked Immunoassay for the in vitro semiquantitative detection of IgM antibodies to ß2-Glycoprotein-I in human serum. The presence of ß2-GPI antibodies can be used in conjunction with other serological tests and clinical findings to aid in the assessment of the risk from thrombosis in patients with Systemic Lupus Erythematosus or other lupus like disorders.

Device Description

Not Found

AI/ML Overview

I apologize, but this document does not contain the information requested about acceptance criteria and a study proving device performance. This is a 510(k) clearance letter from the FDA for the QAB2A IgM Elisa Kit HRP, which primarily discusses the regulatory approval process based on substantial equivalence to a predicate device.

The document does not include:

  1. A table of acceptance criteria and reported device performance.
  2. Details about sample sizes for test sets, data provenance.
  3. Information on experts used to establish ground truth or adjudication methods.
  4. Any mention of a multi-reader multi-case (MRMC) comparative effectiveness study or human-in-the-loop performance.
  5. A standalone algorithm performance study.
  6. The type of ground truth used (e.g., pathology, outcomes data).
  7. Sample size for the training set or how its ground truth was established.

This document is a formal notification of FDA clearance, indicating that the device has been deemed substantially equivalent to a legally marketed predicate device, allowing it to be marketed. It refers to an "Indications for Use Statement" (on page 2 of the provided text), but this statement defines the intended use of the device, not its performance specifications or the results of a performance study.

§ 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).