VIRAMED BIOTECH BORRELIA B31 IGG VIRABLOT

K051071 · Viramed Biotech AG · LSR · Aug 11, 2005 · Microbiology

Device Facts

• Record ID: K051071
• Device Name: VIRAMED BIOTECH BORRELIA B31 IGG VIRABLOT
• Applicant: Viramed Biotech AG
• Product Code: LSR · Microbiology
• Decision Date: Aug 11, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.3830
• Device Class: Class 2

Intended Use

The Viramed Biotech Borrelia B31 IgG ViraBlot® is an in vitro qualitative assay for the detection of IgG antibodies to Borrelia burgdorferi in human serum. It is intended for use in the testing of human serum samples which have been found positive 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 for Lyme disease. The Viramed Biotech Borrelia B31 IgG Virablot® can be used anytime after onset provided the EIA or IFA are positive or equivocal. It should also be used for follow-up when: 1) Only IgM antibodies were found positive in a Western blot, 2) IgG antibodies were found by Western blot but were not considered significant by the CDC criteria for a positive IgG Western blot, 3) previously tested seronegative individuals are shown to develop antibodies by an EIA or IFA test.

Device Story

The Borrelia B31 IgG ViraBlot® is an in vitro diagnostic Western blot assay used to detect IgG antibodies to Borrelia burgdorferi in human serum. It serves as a confirmatory test for samples previously screened as positive or equivocal by EIA or IFA methods. The device is intended for use in clinical laboratory settings by trained laboratory personnel. The assay provides qualitative results that serve as supportive evidence of Lyme disease infection. By identifying specific IgG antibodies, the test assists clinicians in confirming diagnoses for patients who have shown initial reactivity in screening tests or require follow-up due to inconclusive prior results. The output is interpreted by healthcare providers to aid in the clinical diagnosis of Lyme disease.

Clinical Evidence

Clinical sensitivity evaluated in 100 patients: 25% (5/20) for acute erythema migrans, 25% (5/20) for convalescent erythema migrans, 60% (12/20) for early-disseminated neuroborreliosis, and 95% (38/40) for late-stage Lyme arthritis. Specificity 100% (200/200) in normal blood donors. Correlation with CDC Lyme Disease Panel 95% (42/44). CAP 2003 proficiency panel correlation 100% (15/15).

Technological Characteristics

Western blot assay; nitrocellulose support membrane; electrophoretically isolated B. burgdorferi antigens. Manual visual interpretation of precipitated substrate bands. No electronic sensing or energy source required. Standalone diagnostic kit.

Indications for Use

Indicated for qualitative detection of IgG antibodies to Borrelia burgdorferi in human serum. Used as follow-up for patients with positive/equivocal EIA or IFA results, or for follow-up of IgM-positive Western blots, non-significant IgG Western blots, or seroconversion in previously seronegative individuals.

Regulatory Classification

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), the Treponema pallidum immobilization test (T.P.I.), and other treponemal tests used to identify antibodies to Treponema pallidum directly from infecting treponemal organisms in serum. The identification aids in the diagnosis of syphilis caused by bacteria belonging to the genus Treponema and provides epidemiological information on syphilis.

Submission Summary (Full Text)

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Food and Drug Administration 2098 Gaither Road Rockville MD 20850

AUG 1 1 2005

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

Re: k051071

Trade/Device Name: Borrelia B31 IgG 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 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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This letter will allow you to begin marketing your device as described in your Section 510(k) I his letter whil anow you to oegin manitoting of substantial equivalence of your device to a legally premarked predicate device results in a classification 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, If you destic specific information access in of your device, please contact the Office of In or questions on the promotion and Safety at [phone]. 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 Tou may obtain of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html

Sincerely yours,

Sales, a Hong

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

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Viramed Biotech: Est. #3004181478 / Borrelia B31 IgG Virablot® 510 (k) Submission/Page 10

## Appendix C. Indication of Use Statement

510(k) Number: K051071

Device Name: Borrelia B31 IgG Virablot®

Indication for Use:

The Viramed Biotech Borrelia B31 IgG ViraBlot® is an in vitro qualitative assay for the detection of IgG antibodies to Borrelia burgdorferi in human serum. It is intended for use in the testing of human serum samples which have been found positive 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 for Lyme disease. The Viramed Biotech Borrelia B31 IgG Virablot® can be used anytime after onset provided the EIA or IFA are positive or equivocal. It should also be used for follow-up when: 1) Only IgM antibodies were found positive in a Western blot, 2) IgG antibodies were found by Western blot but were not considered significant by the CDC criteria for a positive IgG Western blot, 3) previously tested seronegative individuals are shown to develop antibodies by an EIA or IFA test.

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

Prescription Use _____________________________________________________________________________________________________________________________________________________________

AND/OR

Over-The-Counter Use

(Part 21 CFR 801 Subpart D)

(21 CFR 801 Subpart C)

510k)_

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

| Division Sign-Off | |
|-----------------------------------------------------------------------------------------------|----------------------------------|
| Concurrence of CDRH, Office of Device Evaluation (ODE) | <p>fole a</p> |
| | Office of In Vitro Diagnosi Devi |
| | Evaluation and Safety |
| Manufactured by Viramed Biotech AG, Behringstrasse, 11, Planegg/Steinkerchen, Germany D-82152 | |
| 760 594-7285 | |