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K Number
K022990
Device Name
REAADS IGA ANTI-CARDIOLIPIN SEMI-QUANTITATIVE TEST KIT, MODEL 026-001
Manufacturer
CORGENIX, INC.
Date Cleared
2002-09-25

(16 days)

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

An enzyme-linked immunosorbent assay (ELISA) for the determination of IgA anti-cardiolipin antibodies in human serum or plasma. For the detection and semi-quantitation of anti-cardiolipin antibodies in individuals with systemic lupus erythematosus (SLE) and lupus-like disorders (anti-phospholipid syndrome).

Device Description

An enzyme-linked immunosorbent assay (ELISA) for the determination of IgA anti-cardiolipin antibodies in human serum or plasma.

AI/ML Overview

While the document confirms that the REAADS IgA Anti-Cardiolipin Semi-Quantitative Test Kit is approved for marketing, it does not contain the detailed study information required to answer your request fully.

Specifically, the document is a 510(k) clearance letter, which indicates substantial equivalence to a predicate device but does not typically include the full clinical study report, acceptance criteria, or performance data in the level of detail you've requested.

Therefore, many of your questions cannot be answered from the provided text.

Here's what can and cannot be answered based on the input:

What can be answered:

  • Device Name: REAADS IgA Anti-Cardiolipin Semi-Quantitative Test Kit
  • Indications for Use: An enzyme-linked immunosorbent assay (ELISA) for the determination of IgA anti-cardiolipin antibodies in human serum or plasma. For the detection and semi-quantitation of anti-cardiolipin antibodies in individuals with systemic lupus erythematosus (SLE) and lupus-like disorders (anti-phospholipid syndrome).
  • Study type implied: The 510(k) clearance implies that a study was conducted to demonstrate substantial equivalence to a predicate device, but the details of that study are not present.

What cannot be answered from the provided text:

  1. A table of acceptance criteria and the reported device performance: This information is not in the document.
  2. Sample size used for the test set and the data provenance: This information is not in the document.
  3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: This information is not in the document.
  4. Adjudication method for the test set: This information is not in the document.
  5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and if so, what was the effect size of how much human readers improve with AI vs without AI assistance: This device is an ELISA test kit, not an AI-assisted diagnostic imaging device for human readers. Therefore, an MRMC study related to AI assistance is not applicable.
  6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: This is an in-vitro diagnostic (IVD) test kit, not an algorithm. Standalone performance is inherent in its design as an automated assay, but specific "standalone study" details are not provided.
  7. The type of ground truth used: This information is not in the document. For an ELISA, ground truth would typically be established by a combination of clinical diagnoses and potentially other established laboratory methods, but specifics are missing.
  8. The sample size for the training set: This information is not in the document. (For an IVD kit, "training set" might refer to assay development and optimization, not machine learning training).
  9. How the ground truth for the training set was established: This information is not in the document.

To obtain the detailed study information you're looking for, you would typically need to consult the full 510(k) submission summary or associated clinical studies, which are not included in this FDA clearance letter.

§ 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).