BIRAMED BIOTECH BORRELIA B31 IGM VIRABLOT by VIRAMED BIOTECH AG

The Viramed Biotech Borrelia B31 IgM ViraBlot® is an in vitro qualitative assay for the detection of IgM antibodies to Borrelia burgdorferi in human serum. It is intended for use in testing human serum samples which have been found insitive or equivocal using an EIA or IFA test procedure for B. burgdorferi antibodies. Positive results from this Western Blot assay are supportive evidence of infection with B. burgdorferi, the causative agent of Lyme disease. The Viramed Biotech Borrelia B31 ViraBlot can be used during the acute phase (0-4 weeks of symptoms onset) of B. burgdorferi infection. After this early period, infected patients are usually found to be Western blot positive for IgG. A positive IgM test alone is not recommended for use in determining active disease in persons with illness of longer than one month.

Device Description

Not Found

AI/ML Overview

Acceptance Criteria and Device Performance for Borrelia B31 IgM Virablot®

The provided document describes the FDA's substantial equivalence determination for the Borrelia B31 IgM Virablot®, stating it is substantially equivalent to legally marketed predicate devices. However, the document does not include specific acceptance criteria or details of a study that proves the device meets those criteria. It is a regulatory clearance letter rather than a detailed performance study report.

Therefore, I cannot fulfill the request for a table of acceptance criteria and reported device performance from the provided text. The document outlines the "Indication for Use" (refer to page 2 and 3) which broadly defines the intended application of the device, but this is distinct from specific performance metrics and their associated acceptance thresholds.

Without that specific information, I cannot answer the remaining points of your request regarding:

Sample size and data provenance for the test set
Number and qualifications of experts for ground truth
Adjudication method
MRMC comparative effectiveness study details
Standalone performance details
Type of ground truth used
Sample size for the training set
How ground truth for the training set was established

In summary, the provided FDA 510(k) clearance letter acknowledges the device's substantial equivalence but does not contain the detailed performance data, acceptance criteria, or study design information requested.

Summary

{0}------------------------------------------------

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 seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle or bird-like figure, with three stylized lines forming the body and wings.

AUG 1 1 2005

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Viramed Biotech AG c/o Barry E. Menefee, Ph.D. Chief of Operations Viralab, Inc. 1730 South Ditmar Street Oceanside, CA 92054

$\vec{r}$

K051169 Re:

Trade/Device Name: Borrelia B31 IgM Virablot® Regulation Number: 21 CFR 866.3830 Regulation Name: Treponema Pallidum Treponemal Test Reagents Regulatory Class: Class II Product Code: LSR Dated: June 28, 2005 Received: June 29, 2005

Dear Dr. Menefee:

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 eoninered prox 8 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 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 r read be a 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 or car) I 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).

{1}------------------------------------------------

Page 2 -

This letter will allow you to begin marketing your device as described in your Section 510(k) I his letter with anow you to oogin manag of substantial equivalence of your device to a legally premarket notification: "The PDF interlig on for your device and thus, permits your device to proceed to the market. > - - -------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

If you desire specific information about the application of labeling requirements to your device, i If you destions on the promotion and advertising of your device, please contact the Office of In or questions on the prome Evaluation and Safety at (240)276-0484. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the I va may ovaill other generational 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/industry/support/index.html

Sincerely yours,

Sally a Forry

Sally A. Hojvat, M.Sc., Ph.D. Director Division of Microbiology Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

{2}------------------------------------------------

Appendix C. Indication of Use Statement

510(k) Number: K051169

Device Name: Borrelia B31 IgM Virablot®

Indication for Use:

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use X

AND/OR

Over-The-Counter Use

(21 CFR 801 Subpart C)

Office of In

(Part 21 CFR 801 Subpart D)

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

Concurrence of CDRH, Office of Device Evaluation

Manufactured by Viramed Biotech AG, Behringstrasse, 11, Planegg/Steinkerchen എന്നിബന്ദി സ്ഥിപ്പിച്ച 760 594-7285

KOS 116 9

Diagnostic I

Regulation Number and Section

§ 866.3830

Treponema pallidum treponemal test reagents.(a)
Identification. Treponema pallidum treponemal test reagents are devices that consist of the antigens, antisera and all control reagents (standardized reagents with which test results are compared) which are derived from treponemal sources and that are used in the fluorescent treponemal antibody absorption test (FTA-ABS), theTreponema pallidum immobilization test (T.P.I.), and other treponemal tests used to identify antibodies toTreponema pallidum directly from infecting treponemal organisms in serum. The identification aids in the diagnosis of syphilis caused by bacteria belonging to the genusTreponema and provides epidemiological information on syphilis.(b)
Classification. Class II (performance standards).