REAADS ANTI-BETA 2 GLYCOPROTEIN I IGM TEST KIT by CORGENIX, INC.

The REAADS Anti-B2GPI Test Kit is an in vitro diagnostic assay for the detection and semi-quantitation THE KEADS AM-D2GFI antibodies in human serum or plasma as an aid for assessing the risk of the risk of the make in 01 TEM and DEOTT annovetes in hemantosus (SLE) and lupus-like disorders (antiphospholipid syndrome).

Device Description

Not Found

AI/ML Overview

This is an in vitro diagnostic (IVD) device, and the provided text is a 510(k) clearance letter from the FDA. It does not contain the detailed technical study information typically found in a Section 510(k) Premarket Notification submission or a clinical study report. Therefore, most of the requested information regarding acceptance criteria and study details cannot be extracted from this document alone.

Here's what can be inferred or stated based on the provided text, and where gaps exist:

A table of acceptance criteria and the reported device performance
- Not available in this document. The clearance letter confirms the device is substantially equivalent to a predicate device. The actual performance data (e.g., sensitivity, specificity, accuracy) and the acceptance criteria used to demonstrate this equivalence are typically found in the 510(k) submission itself, not the clearance letter.
Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
- Not available in this document. The number of samples for the test set, their origin, and whether the study was retrospective or prospective would be detailed in the study report within the 510(k) submission.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)
- Not applicable / Not available. For an IVD like an antibody test, "ground truth" is typically established by well-characterized patient samples (e.g., from diagnosed patients and healthy controls) or by comparison to a gold standard laboratory method, rather than by expert consensus. This document does not describe the method for establishing ground truth for the test set.
Adjudication method (e.g., 2+1, 3+1, none) for the test set
- Not applicable / Not available. Adjudication methods like 2+1 or 3+1 are typically used in imaging studies where human readers provide interpretations that need to be resolved. For an IVD, the assay result is generally definitive, and ground truth is established externally.
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. This is an in vitro diagnostic test kit (REAADS IgM anti-B2GPI Test Kit) used to detect antibodies in human serum or plasma. It is not an AI-powered diagnostic imaging device that assists human readers. Therefore, an MRMC study comparing human readers with and without AI assistance is not relevant to this device.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Yes, by nature of the device. This is an in vitro diagnostic test kit. It is designed to produce results directly from a biological sample. Its performance is evaluated intrinsically through laboratory studies (e.g., analytical and clinical performance studies) rather than as an algorithm requiring human interaction for interpretation in a clinical context. The "standalone" performance is its core function.
The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not explicitly stated in this document. For this type of IVD, ground truth would typically be established by:
  - Clinical diagnosis of Systemic Lupus Erythematosus (SLE) or antiphospholipid syndrome (based on clinical criteria, other laboratory tests, and patient history).
  - Comparison to a validated reference method for IgM anti-B2GPI antibodies, if one exists and is considered a gold standard.
  - Patient outcomes or follow-up data, although this is less common for establishing initial diagnostic performance.
The sample size for the training set
- Not applicable / Not available. This device is a manual or semi-automated assay kit for laboratory use, not a machine learning or AI algorithm that requires a "training set" in the computational sense. The "training" for such a device involves optimizing reagent concentrations, incubation times, and other assay parameters during its development, but this isn't typically referred to as a "training set" in the context of AI/ML.
How the ground truth for the training set was established
- Not applicable / Not available. As noted above, this concept of a "training set" with established ground truth is not relevant to this type of IVD device.

Summary of available information:

Device Name: REAADS IgM anti-B2GPI Test Kit
Indications for Use: In vitro diagnostic assay for the detection and semi-quantitation of IgM anti-B2GPI antibodies in human serum or plasma as an aid for assessing the risk of thrombotic events in Systemic Lupus Erythematosus (SLE) and lupus-like disorders (antiphospholipid syndrome). Intended for use by clinical (hospital and reference) laboratories.
Regulatory Status: 510(k) cleared, substantially equivalent to predicate devices.
Performance Study Information: Not available in this document.

Summary

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. Inside the circle is a stylized symbol featuring three abstract human profiles facing to the right, with flowing lines extending from the bottom of the profiles.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Ms. Nanci Dexter Director, Quality Assurance and Regulatory Affairs Corgenix, Inc. 12061 Tejon Street Westminster, Colorado 80234

SEP 2 8 2001

Re: K013077

Trade/Device Name: REAADS IgM anti-B2GPI Test Kit Regulation Number: 21 CFR § 866.5660 Regulation Name: Multiple Autoantibodies Immunological Test System Regulatory Class: II Product Code: MSV Dated: September 11, 2001 Received: September 14, 2001

Dear Ms. Dexter:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4588. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

Steven Putman

Steven I. Gutman, M.D., M.B.A. Director Division of Clinical Laboratory Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use Statement

510(k) Number: K013077

Device Name: REAADS IgM anti-B2GPI Test Kit Indications for Use:

The REAADS IgM anti-B2GPI Test Kit is intended to be used by clinical (hospital and reference) laboratories.

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NECESSARY)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Donald S. Bell

(Division Sign-Off

510(k) Number_Ko13077

Prescription Use $\underline{\hspace{1cm}}$ $\checkmark$

Regulation Number and Section

§ 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).