Gold Standard Diagnostics Borrelia burgdorferi VlsE-OspC IgG/IgM ELISA Test Kit

K203289 · Gold Standard Diagnostics · LSR · Mar 22, 2021 · Microbiology

Device Facts

• Record ID: K203289
• Device Name: Gold Standard Diagnostics Borrelia burgdorferi VlsE-OspC IgG/IgM ELISA Test Kit
• Applicant: Gold Standard Diagnostics
• Product Code: LSR · Microbiology
• Decision Date: Mar 22, 2021
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.3830
• Device Class: Class 2

Intended Use

The Gold Standard Diagnostics Borrelia burgdorferi VlsE-OspC IgG/IgM ELISA Test Kit is intended as a qualitative test for the detection of IgG and IgM class antibodies to VlsE and OspC antigens from Borrelia burgdorferi sensu stricto in human serum from symptomatic patients or people suspected of having Lyme disease. When used as the first-tier screening test, positive and equivocal results must be confirmed through additional testing by one of the following methods: a) Standard two-tier test methodology (STTT) using an IgG and/or IgM blot testing following current interpretation guidelines, OR b) Modified two-tier test methodology (MTTT) using one or more of the following three ELISA based assays: Gold Standard Diagnostics Borrelia burgdorferi IgG/IgM ELISA Test, Gold Standard Diagnostics Borrelia burgdorferi IgG ELISA Test, Gold Standard Diagnostics Borrelia burgdorferi IgM ELISA Test. The assay can also be used as a second-tier confirmation test using the MTTT methodology when used with one or more of the following three ELISA based assays: Gold Standard Diagnostics Borrelia burgdorferi IgG/IgM ELISA Test, Gold Standard Diagnostics Borrelia burgdorferi IgG ELISA Test, Gold Standard Diagnostics Borrelia burgdorferi IgM ELISA Test. Positive test results by either the STTT or MTTT methodology are supportive evidence for the presence of antibodies and exposure to Borrelia burgdorferi, the cause of Lyme disease. A diagnosis of Lyme disease should be made based on the presence of Borrelia burgdorferi antibodies, history, symptoms, and other laboratory findings.

Device Story

In vitro diagnostic ELISA test kit; detects IgG/IgM antibodies to VlsE and OspC antigens of Borrelia burgdorferi in human serum. Used in clinical laboratories by trained personnel. Input: patient serum sample. Process: enzyme-linked immunosorbent assay (ELISA) targeting specific Borrelia antigens. Output: qualitative result (positive/negative/equivocal). Clinical utility: aids diagnosis of Lyme disease when combined with patient history, symptoms, and other laboratory findings. Supports both Standard Two-Tier Test (STTT) and Modified Two-Tier Test (MTTT) diagnostic algorithms. Results provide evidence of exposure to Borrelia burgdorferi.

Clinical Evidence

Clinical performance evaluated via prospective study (n=481) and characterized samples (n=125). Sensitivity/specificity compared against STTT (Western Blot) and MTTT (ELISA-based) algorithms. CDC reference panel (n=280) used for validation. Results demonstrate high agreement with clinical diagnosis and predicate device. PPA for MTTT [IgG/IgM] vs WB-STTT was 100% (95% CI: 90.3-100%).

Technological Characteristics

ELISA-based immunoassay; utilizes VlsE and OspC antigens for detection of IgG and IgM antibodies. Qualitative detection method. In vitro diagnostic reagent.

Indications for Use

Indicated for qualitative detection of IgG and IgM antibodies to VlsE and OspC antigens of Borrelia burgdorferi in human serum. For use in symptomatic patients or individuals suspected of having Lyme disease. Used as first-tier screening or second-tier confirmation in two-tier testing algorithms.

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)

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left, there is a symbol representing the Department of Health & Human Services - USA. To the right of the symbol, there is the FDA logo in blue, with the words "U.S. FOOD & DRUG" stacked on top of the word "ADMINISTRATION".

March 22, 2021

Gold Standard Diagnostics Jennifer Roth Vice President, Product Development 2851 Spafford St. Davis, California 95618

Re: K203289

Trade/Device Name: Gold Standard Diagnostics Borrelia burgdorferi VlsE-OspC IgG/IgM ELISA Test Kit Regulation Number: 21 CFR 866.3830 Regulation Name: Treponema pallidum treponemal test reagents Regulatory Class: Class II Product Code: LSR Dated: November 4, 2020 Received: November 9, 2020

Dear Jennifer Roth:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.

{1}------------------------------------------------

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) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely.

Maria Ines Garcia, Ph.D. Branch Chief Division of Microbiology Devices OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

{2}------------------------------------------------

# Indications for Use

## 510(k) Number (if known) K203289

#### Device Name

Gold Standard Diagnostics Borrelia burgdorferi VlsE-OspC IgG/IgM ELISA Test Kit

### Indications for Use (Describe)

The Gold Standard Diagnostics Borrelia burgdorferi VISE-OspC IgG/IgM ELISA Test Kit is intended as a qualitative test for the detection of IgG and IgM class antibodies to VIsE and OspC antigens from Borrelia burgdorferi sensu stricto in human serum from symptomatic patients or people suspected of having Lyme disease. When used as the first-tier screening test, positive and equivocal results must be confirmed through additional testing by one of the following methods:

• Standard two-tier test methodology (STTT) using an IgG and/or IgM blot testing following current interpretation guidelines. OR

• Modified two-tier test methodology (MTTT) using one or more of the following three ELISA based assays:

a. Gold Standard Diagnostics Borrelia burgdorferi IgG/IgM ELISA Test

b. Gold Standard Diagnostics Borrelia burgdorferi IgG ELISA Test

c. Gold Standard Diagnostics Borrelia burgdorferi IgM ELISA Test

The assay can also be used as a second-tier confirmation test using the MTTT methodology when used with one or more of the following three ELISA based assays:

a. Gold Standard Diagnostics Borrelia burgdorferi IgG/IgM ELISA Test

b. Gold Standard Diagnostics Borrelia burgdorferi IgG ELISA Test

c. Gold Standard Diagnostics Borrelia burgdorferi IgM ELISA Test

Positive test results by either the STTT or MTTT methodology are supportive evidence for the presence of antibodies and exposure to Borrelia burgdorferi, the cause of Lyme disease. A diagnosis of Lyme disease should be made based on the presence of Borrelia burgdorferi antibodies. history, symptoms, and other laboratory findings.

| Type of Use (Select one or both, as applicable) | | |
|-------------------------------------------------|-----------------------------------------------|--|
| X Prescription Use (Part 21 CER 801 Subnart D) | Over The Counter I Ice (21 CED 801 Subnart C) | |

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

## *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

> Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{3}------------------------------------------------

Image /page/3/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

Gold Standard Diagnostics Jennifer Roth Vice President, Product Development 2851 Spafford St. Davis, California 95618

Re: K203289

Trade/Device Name: Gold Standard Diagnostics Borrelia burgdorferi VlsE-OspC IgG/IgM ELISA Test Kit Regulation Number: 21 CFR 866.3830 Regulation Name: Treponema pallidum treponemal test reagents Regulatory Class: Class II Product Code: LSR Dated: November 4, 2020 Received: November 9, 2020

Dear Jennifer Roth:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.

{4}------------------------------------------------

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) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely.

Maria Ines Garcia, Ph.D. Branch Chief Division of Microbiology Devices OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure