BIRAMED BIOTECH BORRELIA B31 IGM VIRABLOT

K051169 · Viramed Biotech AG · LSR · Aug 11, 2005 · Microbiology

Device Facts

• Record ID: K051169
• Device Name: BIRAMED BIOTECH BORRELIA B31 IGM 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 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 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 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 Story

The Viramed Biotech Borrelia B31 IgM ViraBlot is an immunoblot assay for detecting IgM antibodies to Borrelia burgdorferi in human serum. The device utilizes electrophoretically isolated antigens bound to a nitrocellulose membrane. Patient serum is incubated with the strip; specific antibodies bind to antigens. After washing, an enzyme-labeled anti-human IgM conjugate is added, followed by a substrate that produces a color change at specific band locations upon reaction. The presence of colored precipitation indicates antibody presence. Results are interpreted by comparing band patterns to a lot-specific band locator. The test is performed in a laboratory setting by qualified technicians. It serves as a secondary test for samples previously screened by EIA or IFA. The output provides supportive evidence of B. burgdorferi infection, aiding clinicians in diagnosing Lyme disease during the acute phase.

Clinical Evidence

Performance evaluated using 100 clinically diagnosed Lyme borreliosis samples. Sensitivity: 70% (acute/erythema migrans), 95% (convalescent/erythema migrans), 95% (early disseminated neuroborreliosis), and 35% (late stage Lyme arthritis). Analytical specificity was 96% (194/200) in normal blood donors. Method comparison with predicate showed 62.5% to 85% agreement. Correlation with CDC Lyme Disease Panel was 86.4% (38/44). Reproducibility study across three sites and six readers demonstrated 100% concordance in 18 of 19 bands.

Technological Characteristics

In vitro qualitative Western Blot assay for IgM antibody detection. Utilizes human serum samples. Manual or semi-automated laboratory test format.

Indications for Use

Indicated for qualitative detection of IgM antibodies to Borrelia burgdorferi in human serum. Intended for patients with sensitive or equivocal EIA/IFA test results. Used during acute phase (0-4 weeks post-symptom onset) of B. burgdorferi infection. Not recommended for determining active disease in patients with illness >1 month.

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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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

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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).

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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 [phone]. 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 [phone] or [phone] 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

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## Appendix C. Indication of Use Statement

510(k) Number: K051169

Device Name: Borrelia B31 IgM Virablot®

Indication for Use:

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.

(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

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