REAADS IGA ANTI-B2GP 1 TEST KIT by CORGENIX, INC.

The REAADS IgA anti-B2GPI Test Kit is an in vitro diagnostic assay for the detection and semi-quantitation of I he real and in the man serum as an aid for assessing the risk of thrombosis in individuals with systemic lupus erythematosus (SLE) and lupus-like disorders (antiphospholipid syndrome).

Device Description

The REAADS IgA anti-B2GPI Test Kit is an enzyme-linked immunosorbent assay (ELISA), utilizing the 96-microwell plate format, similar to the predicate device. Diluted serum samples, calibrator sera, and controls are incubated in microwells coated with purified human Beta-2 Glycoprotein I. Incubation allows the anti-B2GPI antibodies present in the samples to react with the immobilized antigen. After the removal of unbound serum proteins by washing, antibodies specific for human IgA, labeled with horseradish peroxidase (HRP), are added forming complexes with the B2GPI bound antibodies. Following another washing step, the bound enzyme-antibody conjugate is assayed by the addition of a single solution containing tetramethlybenzidine (TMB) and hydrogen peroxide (H2Q2) as the chromogenic substrate. The intensity of the color generated is proportional to the serum concentration of anti-B2GPI antibodies. Optical density is read spectrophotometrically at 450nm. The total incubation time (at room temperature) of the assay is 40 minutes. The assay makes use of a single point calibrator to measure the amount of IgA anti-B2GPI antibodies in patient samples.

AI/ML Overview

Here's an analysis of the acceptance criteria and study detailed in the provided document:

The document describes the REAADS IgA anti-B2GPI Test Kit and its comparison to a predicate device, the QUANTA Lite IgA anti B2GPI ELISA. The core of the acceptance criteria and study revolves around demonstrating substantial equivalence to this legally marketed predicate device.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Implicit from Predicate Comparison)	Reported Device Performance (REAADS IgA anti-B2GPI Test Kit)
Sensitivity (for unselected SLE patients, compared to predicate)	25%
Sensitivity (for primary APS patient samples, compared to predicate)	78%
Correlation (between device and predicate for individual values in unselected SLE patients)	Coefficient of correlation: 0.721
Statistical Similarity (between device and predicate)	P-value of 0.015 (by single factor ANOVA), indicating statistically similar results
General Performance Characteristics (compared to predicate)	Comparable
Compliance with published literature (for antiphospholipid syndrome detection)	In compliance

Note: The document focuses on demonstrating substantial equivalence to an existing predicate device rather than defining new, specific, standalone acceptance thresholds. The "acceptance criteria" are derived from the expectation that the new device's performance will be comparable to, and not significantly worse than, the predicate device across various relevant clinical metrics.

2. Sample Size Used for the Test Set and Data Provenance

Test Set Sample Size:
- "unselected SLE patients": Referenced for sensitivity (25%) and correlation (0.721). The exact number is not specified.
- "primary APS patient samples": Referenced for sensitivity (78%). The exact number is not specified.
Data Provenance: The studies were described as "In-house studies," meaning they were conducted by CORGENIX, INC. The country of origin and whether the studies were retrospective or prospective are not explicitly stated. Given the context of seeking 510(k) clearance, these are typically retrospective studies on collected patient samples.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Experts

This information is not provided in the summary. For an in vitro diagnostic test like an ELISA kit, "ground truth" for patient samples (e.g., whether a patient truly has SLE or APS) would typically be established based on accepted clinical diagnostic criteria, possibly involving expert physician diagnosis or other established laboratory tests. The document does not detail how this ground truth was established for the "unselected SLE patients" or "primary APS patient samples."

4. Adjudication Method for the Test Set

The document does not mention any adjudication method used for the test set. Given that this is an ELISA assay, the results are quantitative and objective (optical density readings), so expert adjudication of test results themselves would not typically be applicable. Adjudication might be relevant for establishing the clinical "ground truth" of patient samples, but that detail is missing.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is primarily relevant for imaging diagnostics where human readers interpret images. The REAADS IgA anti-B2GPI Test Kit is an in vitro diagnostic (IVD) ELISA assay, which produces quantitative results read by a spectrophotometer, not human interpretation. Therefore, the concept of "human readers improve with AI vs without AI assistance" is not applicable here.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done

Yes, the primary study presented is a standalone performance assessment of the REAADS IgA anti-B2GPI Test Kit. The device (an ELISA kit) generates results independently. The comparison is between the REAADS kit and another standalone test (the predicate QUANTA Lite IgA anti B2GPI ELISA). There is no "human-in-the-loop" component in the direct performance of the test itself.

7. The Type of Ground Truth Used

The ground truth for sensitivity calculations appears to be based on patient classification into specific clinical conditions: "unselected SLE patients" and "primary APS patient samples." This implies that patients were diagnosed with these conditions using established clinical criteria, which would involve a combination of clinical symptoms, other laboratory tests, and potentially expert physician diagnosis. It is not explicitly stated whether pathology, outcomes data, or a specific expert consensus was used to define these patient cohorts.

8. The Sample Size for the Training Set

The document does not mention any training set size. As an IVD kit, the device itself is a pre-calibrated assay. While there would have been development and optimization, the data presented pertains to the validation of the finalized kit's performance against a predicate, not a machine learning model requiring a distinct training and test set.

9. How the Ground Truth for the Training Set was Established

Since no training set is discussed or implied for the performance study, this question is not applicable.

Summary

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DEC 22 1998

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SUMMARY OF 510(K) SAFETY AND EFFECTIVENESS REAADS IgA anti-B2GPI Test Kit December 01, 1998

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.

The REAADS IgA anti-B2GPI Test Kit is compared to a legally marketed predicate device and a substantial equivalence claim made. The predicate device is QUANTA Lite IgA anti B2GPI ELISA (K973006) currently manufactured and marketed by INOVA Diagnostics, Inc., San Diego, California.

The intended use of the device is for the detection and semi-quantitation of IgA anti-B2GPI antibodies in human serum as an aid for assessing the risk of thrombosis in individuals with systemic lupus ervthematosus (SLE) and lupus-like disorders (antiphospholipid syndrome). Most autoimmune antiphospholipid antibodies require a serum cofactor (B2GPI) for optimal binding. It has been shown that many anti-phospholipid antibodies may react to a neoepitope formed on the B2GPI molecule by the interaction between the phospholipid and B2GPI. In addition, it has been reported that anti-B2GPI antibodies are more specific for thrombosis than antibodies detected by classic antiphospholipid ELISAs. Testing for anti-B2GPI antibodies in the clinical laboratory by ELISA is becoming increasingly valuable and provides additional clinically relevant results to assess patients for the antiphospholipid syndrome and/or the risk of thrombosis.

Performance indicates that REAADS anti-Beta-2 Glycoprotein I and the QUANTA Lite IgA anti B2GPI ELISA are equivalent. In-house studies indicate a sensitivity of 25% for unselected SLE patients and 78% for primary APS patient samples. The coefficient of correlation for individual values in unselected SLE patients showed a good correlation of 0.721 with a P-value of 0.015 (by single factor ANOVA), indicating the results by the two methods are statistically similar. Although differences between the assays are observed, in general, the performance characteristics are comparable. These results are also in compliance with those in published literature for antiphospholipid syndrome detection. The clinical studies performed demonstrate that the REAADS IgA anti-B2GPI Test Kit is safe and effective.

Maurice Austin

/2-i/-4/y

Nanci Dexter Director, Ouality Assurance and Regulatory Affairs

Date

12061 TEJON STREET · WESTMINSTER, CO · 80234 U.S.A. PHONE: 303.457.4345 FAX: 303.457.4519 www.corgenix.com

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Food and Drug Administration 2098 Gaither Road Rockville MD 20850

DEC 22 1998

Ms. Nanci Dexter Director of Quality and Regulatory Affairs CORGENIX, INC. 12061 Tejon St. Westminister, CO 80234

Re: K982434 Trade Name: REAADS IgA anti-B2GPI Test Kit Requlatory Class: II Product Code: MSV Dated: December 1, 1998 Received: December 2, 1998

Dear Ms. Dexter:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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 aqainst misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Requlation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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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 requlation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers 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 Sutman

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

Enclosure

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Indications for Use Statement

510(k) Number: K982434

Device Name: REAADS IgA anti-B2GPI Test Kit

Indications for Use:

The REAADS IgA 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)

Peter E. Malm

Prescription Use

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).