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K Number
K061376
Device Name
EL-ANCA: ANTI-MPO, ANTI-PR3, ANTI-MPO AND ANTI-PR3
Manufacturer
THERATEST LABORATORIES, INC.
Date Cleared
2006-07-20

(64 days)

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

TheraTest EL- ANCATM: anti-MPO- and EL- ANCA™: anti-PR3 are intended for use in clinical laboratories as in vitro diagnostic tests for the detection and measurement of autoantibodies in human serum directed against human neutrophil myeloperoxidase and proteinase 3, respectively. Measurement of anti-MPO aids in the diagnosis of microscopic polyangiitis. Measurement of anti-PR3 aids in the diagnosis of Wegener's granulomatosis.

Device Description

Not Found

AI/ML Overview

I am sorry, but the provided document describes a 510(k) premarket notification for "TheraTest EL-ANCA™" devices, which are in vitro diagnostic tests. The document is a letter from the FDA determining substantial equivalence to predicate devices. It outlines the intended use of the devices for detecting and measuring autoantibodies.

However, the document does not contain information on:

  • Acceptance criteria and reported device performance in a table format.
  • Sample sizes for test sets, data provenance, number of experts, their qualifications, or adjudication methods for establishing ground truth.
  • Information about multi-reader, multi-case (MRMC) comparative effectiveness studies or standalone algorithm performance.
  • The type of ground truth used (e.g., expert consensus, pathology, outcomes data).
  • Sample size for the training set or how ground truth for the training set was established.

This document primarily focuses on the regulatory clearance of the device based on substantial equivalence, rather than detailed performance study design and results that would typically include the requested information.

§ 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).