REAADS VON WILLEBRAND FACTOR ACTIVITY TEST KIT, MODEL 10826 by CORGENIX, INC.

The REAADS von Willebrand Factor Activity Test Kit is an enzyme-linked immunosorbent assay (ELISA) for the quantitative determination of von Willebrand Factor Activity (vWF:Act) in citrated human plasma.

Device Description

The REAADS von Willebrand Factor Activity Test Kit is an enzyme-linked immunosorbent assay (ELISA), utilizing the 96-microwell plate formal, similar to the predicate device. Diluted patient plasma is incubated in the wells, allowing any available antigen to bind to the monoclonal antibody on the microwell surface. The plates are washed to remove unbound proteins or other plasma molecules. Bound antigen is quantitated using horseradish peroxidase (HRP) conjugated anti-human von Willebrand Factor antibody. Following incubation, unbound conjugate is removed by washing. A chromogenic substrate of tetramethylbenzidine (TMB) and hydrogen peroxide (H2O2) is added to develop a colored reaction. The intensity of the color is measured in optical density (O.D.) units with a spectrophotometer at 450mm. Patient von Willebrand Factor Activity in relative percent concentration is determined against a curve made from the reference plasma provided with the kit. The total incubation time (at room temperature) of the assay is 40 minutes.

AI/ML Overview

The provided text describes a 510(k) submission for the REAADS von Willebrand Factor Activity Test Kit. This is an in vitro diagnostic (IVD) device, not an AI/ML medical device. Therefore, many of the requested categories (e.g., sample size for the test set, number of experts for ground truth, adjudication method, MRMC study, standalone performance, training set details) are not directly applicable or reported in the context of an IVD submission.

However, I can extract the information that is available and relevant to an IVD device's acceptance criteria and study.

Here's the information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

For IVDs, "acceptance criteria" are typically related to the analytical performance (e.g., correlation, precision, linearity) compared to a predicate device. The primary "performance" reported here is the correlation with the predicate device.

Acceptance Criteria Category	Specific Metric (Implicit)	Value Achieved / Reported Performance
Equivalence to Predicate	Pearson Product Moment Correlation Coefficient (r)	0.943
Statistical Significance	P-value	P < 0.001

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

Sample Size: 262 clinical samples.
Data Provenance: Not explicitly stated, but derived from "clinical samples," implying human blood plasma samples. The predicate device's manufacturer is based in Dundee, Scotland, but it's not stated if samples were from there or elsewhere. The study is retrospective in the sense that the samples were analyzed and compared, but not a prospective interventional trial.

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

This concept is not directly applicable to an IVD like this. The "ground truth" for an IVD determining a quantitative activity level is typically the result from a reference method or, in this case, the predicate device, which is considered a legally marketed standard. There are no "experts" in the sense of medical professionals interpreting images or clinical data to establish a ground truth diagnosis for this type of quantitative assay.

4. Adjudication Method for the Test Set

Not applicable. This is a quantitative assay comparison, not an interpretation task requiring adjudication.

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

No, an MRMC study is not relevant for this type of quantitative IVD comparison.

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

This concept is not applicable. The device itself is an assay kit. Its "performance" is its analytical output, which is quantitative. It operates in a laboratory setting.

7. The Type of Ground Truth Used

The "ground truth" or reference standard for comparison in this study was the predicate device's measurements (Shield von Willebrand Factor Activity Kit, K000398). The study aimed to demonstrate substantial equivalence by correlating results from the new device with the predicate.

8. The Sample Size for the Training Set

Not applicable as this is an assay kit, not an AI/ML model that requires a training set. The "development" would involve optimizing assay reagents and conditions, not training a statistical model on data.

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

Not applicable; see point 8.

Summary

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KO32139

APR = 5 2004

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SUMMARY OF 510(K) SAPETY AND EFFECTIVENESS REAADS von Willebrand Factor Activity Test Kit March 31, 2004

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 von Willebrand Factor Activity Test Kit is compured to a legally warketed prodicate device and a substantial equivalence claim made. The predicate device is Shield von Willebrand Factor Activity Kit (K000398) currently manufactured and marketed by Shield Diagnostics., Dundee, Scotland.

The intended use of the device is for the quantitative determination of von Willebrand Factor Activity (vWF: Act) in citrated human plasma. The laboratory diagnosis of von Willebrand disease may require both ( 11 the ) and qualitative (functional) determinations to differentiate the two predominant subtypes of the disease, type I and type II. The classification of von Willebrand disease into subtypes is important in determining the course of clinical treatment.

Clinical studies demonstrate that REAADS von Willebrand Factor Activity Test Kit is safe and effective. These clinical studies also indicate that REAADS von Willebrand Factor Activity Test Kit and the Shield I von Willebrand Factor Activity Kit are equivalent. A statistical evaluation of the entire group of clinical samples (n=262) was done to compare the two tests. Using the Pearson Product Moment Correlation statistical analysis, the correlation coefficient (r) demonstrates a positive correlation (r=0.943) and the P value (P<0.001) demonstrates a significant correlation of individual values between both populations.

Name Dept

2004-03-31

Nanci Dexter Director, Quality Assurance and Regulatory Affairs

Date

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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Public Health Service

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

APR - 5 2004

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

Re: . K032139

Trade/Device Name: REAADS von Willebrand Factor Activity Test Kit Regulation Number: 21 CFR 864.7290 Regulation Name: Factor deficiency Test Regulatory Class: Class II Product Code: GGP Dated: March 4, 2004 Received: March 5, 2004

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 Title 21, Code of Federal Regulations (CFR). Parts 800 to 895. 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 Parts 801 and 809); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).

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If you desire specific information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 594-3084. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act 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.

Joseph L. Archellett

Joseph L. Hackett, Ph.D. Acting Director Division of Immunology and Hematology Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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Indications for Use Statement

510(k) Number: K032139

Device Name: REAADS von Willebrand Factor Activity Test Kit

Indications for Use:

The REAADS von Willebrand Factor Activity Test Kit is an enzyme-linked immunosorbent assay (ELSA) for the quantitative determination of von Willebrand Factor Activity (vWF:Act) in citrated human plasma.

The REAADS von Willebrand Factor Activity 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)

Prescription use ✓

Josephine Buttedi
Division Sign-Off

Division Sign-Off

Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) K032139

Regulation Number and Section

§ 864.7290 Factor deficiency test.

(a)
Identification. A factor deficiency test is a device used to diagnose specific coagulation defects, to monitor certain types of therapy, to detect coagulation inhibitors, and to detect a carrier state (a person carrying both a recessive gene for a coagulation factor deficiency such as hemophilia and the corresponding normal gene).(b)
Classification. Class II (performance standards).