← Product Code [LSR](/submissions/MI/subpart-d%E2%80%94serological-reagents/LSR) · K163695

# Borrelia B31 ViraChip IgM Test Kit (K163695)

_Viramed Biotech AG · LSR · Aug 22, 2017 · Microbiology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/LSR/K163695

## Device Facts

- **Applicant:** Viramed Biotech AG
- **Product Code:** [LSR](/submissions/MI/subpart-d%E2%80%94serological-reagents/LSR.md)
- **Decision Date:** Aug 22, 2017
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 866.3830
- **Device Class:** Class 2
- **Review Panel:** Microbiology

## Intended Use

The Viramed Biotech AG Borrelia B31 ViraChip IgM qualitative protein microarray assay for the detection of IgM 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 are supportive evidence of infection with B. burgdorferi, the causative agent for Lyme disease. The Viramed Biotech AG Borrelia B31 ViraChip IgM Test must be used with a ViraChip Reader and the ViraChip Software.

## Device Story

Qualitative protein microarray assay; detects IgM antibodies to Borrelia burgdorferi in human serum. Input: human serum samples (pre-screened via EIA/IFA). Process: microarray-based immunoassay; requires ViraChip Reader and ViraChip Software for analysis. Output: qualitative detection of antibodies. Used in clinical laboratory settings by trained personnel. Results provide supportive evidence for Lyme disease diagnosis; aids clinicians in confirming infection status following initial screening.

## Clinical Evidence

Clinical performance evaluated using 185 clinically defined/culture-confirmed Lyme disease samples (acute EM, early-disseminated, late arthritis) and a 44-sample CDC panel. Sensitivity was 61.1% (113/185) vs 53.5% (99/185) for the predicate. Analytical specificity tested on 199 normal donors (97-99% negative). Cross-reactivity evaluated against 215 specimens; some cross-reactivity observed with Borrelia hermsii, CMV, and Toxoplasma gondii. Precision/reproducibility studies showed 100% agreement for positive/negative calls.

## Technological Characteristics

Protein microarray on nitrocellulose membrane; 96-well microtiter plate format. Antigens: 41kD, 39kD, 23kD. Detection: Alkaline-phosphatase conjugate with colorimetric substrate. Energy source: ViraChip Reader (optical). Connectivity: Integrated with ViraChip Software. Sterilization: N/A.

## Regulatory 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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Public Health Service

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August 22, 2017

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

Viramed Biotech AG Barry Menefee Operations Manager 105 Copperwood Way Suite H Oceanside, California 92058

Re: K163695

Trade/Device Name: Borrelia B31 ViraChip IgM Test Kit Regulation Number: 21 CFR 866.3830 Regulation Name: Treponema pallidum treponemal test reagents Regulatory Class: Class II Product Code: LSR Dated: July 21, 2017 Received: July 25, 2017

Dear Barry 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. 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 Part 801 and Part 809); medical device reporting of

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medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and Part 809), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely.

Steven R. Gitterman -S for

Uwe Scherf, M.Sc., Ph.D. Director Division of Microbiology Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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## Indications for Use

510(k) Number (if known) K163695

Device Name Borrelia B31 ViraChip IgM Test Kit

## Indications for Use (Describe)

The Viramed Biotech AG Borrelia B31 Viro qualitative protein nicroaray assay for the detection of IgM antibodies to Borreia burgdorfer in human serum. It is intended for use in the testing of human serum samples which have been found positive or equivocal using an EA or FFA test procedure for B. burgdorferi antibodies. Positive essay are supportive evidence of infection with B. burgdorfer, the causative agent for Lyme disease.

The Viramed Biotech AG Borrelia B31 ViraChip® IgM Test must be used with a ViraChip® Reader and the ViraChip® Software.

| Type of Use (Select one or both, as applicable) |  |
|-------------------------------------------------|--|
|-------------------------------------------------|--|

X Prescription Use (Part 21 CFR 801 Subpart D)

| | Over-The-Counter Use (21 CFR 801 Subpart C)

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