Anti-Borrelia burgdorferi US EUROLINE-WB (IgM)

K172722 · Euroimmun Us, Inc. · LSR · Dec 10, 2017 · Microbiology

Device Facts

• Record ID: K172722
• Device Name: Anti-Borrelia burgdorferi US EUROLINE-WB (IgM)
• Applicant: Euroimmun Us, Inc.
• Product Code: LSR · Microbiology
• Decision Date: Dec 10, 2017
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.3830
• Device Class: Class 2
• Attributes: Software as a Medical Device

Intended Use

The Anti-Borrelia burgdorferi US EUROLINE-WB (IgM) kit is a Western blot assay intended for the qualitative determination of IgM class antibodies against Borrelia burgdorferi in human serum and plasma (K⁺-EDTA, Li⁺-heparin, Na⁺-citrate) samples that have been found positive or equivocal/borderline using an enzyme immunoassay (EIA) or immunofluorescence assay (IFA) test procedure for Borrelia burgdorferi antibodies. Results can be read manually or automated utilizing EUROLineScan. This test is used as an aid in the diagnosis of infections with Borrelia burgdorferi and the associated diseases, in conjunction with other laboratory and clinical findings.

Device Story

Western blot assay for qualitative detection of IgM antibodies against Borrelia burgdorferi. Input: human serum or plasma samples (K-EDTA, Li-heparin, Na-citrate). Process: electrophoretically separated B. burgdorferi antigen extracts on nitrocellulose strips; patient sample incubation; binding of specific IgM to antigens; enzyme-labeled anti-human IgM conjugate incubation; color reaction with NBT/BCIP substrate. Output: visual presence of specific protein bands (p25, p39, p41). Used in clinical laboratories; operated by trained technicians. Results read manually or via EUROLineScan software. Aids clinicians in Lyme disease diagnosis by confirming EIA/IFA results; supports clinical decision-making regarding infection status.

Clinical Evidence

Clinical sensitivity evaluated using 101 characterized Lyme disease specimens across various disease stages; overall sensitivity 44.6%. Prospective method comparison study (n=304) against predicate showed 96.9% positive agreement and 99.5% negative agreement. Analytical specificity tested in endemic (n=98) and non-endemic (n=100) populations; cross-reactivity panel (n=155) showed no interference from common pathogens or rheumatoid arthritis. CDC panel testing (n=34) provided additional performance characterization.

Technological Characteristics

Western blot assay; qualitative detection of IgM antibodies; utilizes antigen-coated strips; manual or automated readout via EUROLineScan software.

Indications for Use

Indicated for qualitative detection of IgM antibodies against Borrelia burgdorferi in human serum/plasma samples previously tested positive or equivocal/borderline by EIA or IFA. Used as an aid in diagnosing Borrelia burgdorferi infections and associated diseases in conjunction with clinical/laboratory findings.

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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December 10, 2017

EUROIMMUN US, Inc. Michael Locke Director of Regulatory Affairs & Quality Management 1 Bloomfield Ave. Mountain Lakes, New Jersey 07046

Re: K172722

Trade/Device Name: Anti-Borrelia burgdorferi US EUROLINE-WB (IgM) Regulation Number: 21 CFR 866.3830 Regulation Name: Treponema pallidum treponemal test reagents Regulatory Class: Class II Product Code: LSR Dated: September 7, 2017 Received: September 11, 2017

Dear Michael Locke:

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 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.

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If you desire specific advice for your device on our labeling regulation (21 CFR Part 809). please contact the Division of Industry and Consumer Education (DICE) at its toll-free number [phone] or [phone] 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 (DICE) at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely,

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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) K172722

Device Name

Anti-Borrelia burgdorferi US EUROLINE-WB (IgM)

Indications for Use (Describe)

The Anti-Borrelia burgdorferi US EUROLINE-WB (IgM) kit is a Western blot assay intended for the qualitative determination of IgM class antibodies against Borrelia burgdorferi in human serum and plasma (K+-EDTA, Li+-heparin, Na+-citrate) samples that have been found positive or equivocal/borderline using an enzyme immunoassay (EIA) or immunofluorescence assay (IFA) test procedure for Borrelia burgdorferi antibodies. Results can be read manually or automated utilizing EUROLineScan. This test is used as an aid in the diagnosis of infections with Borrelia burgdorferi and the associated diseases, in conjunction with other laboratory and clinical findings.

| Type of Use (Select one or both, as applicable) | |
|-----------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------|
| <span style="font-family: Arial;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) | <span style="font-family: Arial;">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) |

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