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K Number
K013080
Device Name
REAADS ANTI-BETA 2 GLYCOPROTEIN I IGG TEST KIT
Manufacturer
CORGENIX, INC.
Date Cleared
2001-09-28

(14 days)

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

The REAADS Anti-B2GPI Test Kit is an in vitro diagnostic assay for the detection and semi-quantitation of IgG anti-B2GPI antibodies in human serum or plasma as an aid for assessing the risk of thrombosis in patients with Systemic Lupus Erythematosus (SLE) and lupus-like disorders (antiphospholipid syndrome).

Device Description

Not Found

AI/ML Overview

This document is a 510(k) premarket notification approval letter for an in vitro diagnostic device, not a study report. Therefore, it does not contain the detailed information requested regarding acceptance criteria, device performance, sample sizes, ground truth establishment, or expert involvement in a study.

The document approves the marketing of the device based on its substantial equivalence to a legally marketed predicate device, but it does not present the study data or acceptance criteria that led to this determination.

Here's a breakdown of why the requested information cannot be extracted from this document:

  1. A table of acceptance criteria and the reported device performance: This document only states the device name, intended use, and regulatory classification. It does not provide any performance metrics (e.g., sensitivity, specificity, accuracy) or the acceptance criteria used to evaluate these metrics.

  2. Sample sizes used for the test set and the data provenance: Not present.

  3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not present.

  4. Adjudication method: Not present.

  5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable, as this is not an AI-assisted diagnostic device. It's an in vitro diagnostic assay. Even if it were relevant, the document does not contain this information.

  6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable, as this is an in vitro diagnostic assay, not an algorithm-only device. Even if it were relevant, the document does not contain this information.

  7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not present.

  8. The sample size for the training set: Not present.

  9. How the ground truth for the training set was established: Not present.

§ 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).