The EUROIMMUN Anti-Borrelia burgdorferi US Westernblot (IgG) kit is a Western blot assay intended for the qualitative determination of IgG 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 B. burgdorferi and the associated diseases, in conjunction with other laboratory and clinical findings.

Device Description

The EUROIMMUN Anti-Borrelia burgdorferi US Westernblot (IgG) kit is a Western blot assay. Results can be read manually or automated utilizing EUROLineScan.

AI/ML Overview

This FDA 510(k) clearance letter and Indications for Use document do not contain the detailed information necessary to fully describe the acceptance criteria and the study that proves the device meets those criteria, as typically found in a clinical study report or a detailed 510(k) summary. The document focuses on the regulatory clearance and general intended use of the device.

However, based on the information provided, here's what can be extracted and what information is missing:

1. A table of acceptance criteria and the reported device performance:

This information is not available in the provided document. A 510(k) summary would typically include a detailed comparison to a predicate device, showing performance metrics like sensitivity and specificity. The document only states that the device is "substantially equivalent" to legally marketed predicate devices.

2. Sample size used for the test set and the data provenance:

Sample Size for Test Set: This information is not available in the provided document.
Data Provenance: This information is not available in the provided document.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

This information is not available in the provided document.

4. Adjudication method for the test set:

This information is not available in the provided document.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

The device description states: "Results can be read manually or automated utilizing EUROLineScan." This indicates that there's an automated interpretation component. However, the document does not provide any information about an MRMC study or the effect size of human readers improving with AI assistance. This type of study is more common for diagnostic imaging AI devices, whereas this device is a Western blot assay.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:

The statement "Results can be read manually or automated utilizing EUROLineScan" suggests that the automated utilization of EUROLineScan implies an algorithmic interpretation. However, the document does not provide specific performance data for the algorithm in a standalone manner or comparisons to human-in-the-loop performance.

7. The type of ground truth used:

This information is not explicitly stated in the provided document. For a diagnostic test like this, the ground truth would typically be established by a combination of clinical diagnosis, other laboratory tests (e.g., culture, PCR, or a consensus of multiple reference tests), follow-up on disease progression, or expert clinical judgment.

8. The sample size for the training set:

This information is not available in the provided document.

9. How the ground truth for the training set was established:

This information is not available in the provided document.

Summary of missing information:

The provided documents (FDA 510(k) clearance letter and Indications for Use) serve as regulatory approval but do not contain the detailed study results, acceptance criteria, or specifics of how the device's performance was evaluated against a ground truth dataset, which would typically be found in a more comprehensive technical report or the 510(k) summary document that would have been submitted to the FDA.

Summary

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Public Health Service

August 25, 2016

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

EUROIMMUN US Michael Locke Director of Regulatory Affairs 1 Bloomfield Avenue Mountain Lakes, NJ 07046

Re: K161513

Trade/Device Name: EUROIMMUN Anti-Borrelia burgdorferi US Westernblot (IgG) Regulation Number: 21 CFR 866.3830 Regulation Name: Treponema pallidum treponemal test reagents Regulatory Class: II Product Code: LSR Dated: May 26, 2016 Received: June 2, 2016

Dear Mr. 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 Parts 801 and 809); medical device reporting (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 regulations (21 CFR Parts 801 and 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/Resourcesfor You/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 yours.

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) K161513

Device Name

EUROIMMUN Anti-Borrelia burgdorferi US Westernblot (IgG)

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
☑ Prescription Use (Part 21 CFR 801 Subpart D)	☐ Over-The-Counter Use (21 CFR 801 Subpart C)

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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).