ZEUS Solinas Borrelia VlsE1/pepC10 IgG/IgM Test System; ZEUS Solinas Borrelia VlsE1/pepC10 IgG/IgM Control Kit

K230863 · Zeus Scientific · LSR · Jul 13, 2023 · Microbiology

Device Facts

• Record ID: K230863
• Device Name: ZEUS Solinas Borrelia VlsE1/pepC10 IgG/IgM Test System; ZEUS Solinas Borrelia VlsE1/pepC10 IgG/IgM Control Kit
• Applicant: Zeus Scientific
• Product Code: LSR · Microbiology
• Decision Date: Jul 13, 2023
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.3830
• Device Class: Class 2

Intended Use

ZEUS Solinas Borrelia VlsE1/pepC10 IgG/IgM Test System The ZEUS Solinas Borrelia VlsE1/pepC10 IgG/IgM Test System uses chemiluminescent immunoassay (CLIA) technology for the qualitative detection of IgG/IgM antibodies to Borrelia burgdorferi in human serum. This assay is intended for use on samples from patients with signs and symptoms consistent with or patients suspected of having Lyme disease to assess the presence of IgG/IgM antibodies. Positive results with the ZEUS Solinas Borrelia VlsE1/pepC10 IgG/IgM Test System should be supplemented with additional testing with a Standard two-tier test (STTT) methodology using an IgG and/or IgM Borrelia burgdorferi immunoblot assay following current guidelines. Positive supplemental results are supportive evidence of the presence of antibodies and exposure to Borrelia burgdorferi and may be used along with patient history, symptoms and other laboratory data to support a clinical diagnosis of Lyme disease. Negative results by the ZEUS Solinas Borrelia VlsE1/pepC10 IgG/IgM Test System should not be used to exclude Lyme disease. The test must be performed on the ZEUS Solinas α instrument. ZEUS Solinas Borrelia VlsE1/pepC10 IgG/IgM Control Kit The ZEUS Solinas Borrelia VlsE1/pepC10 IgG/IgM Control Kit is intended for use as assayed quality control samples to monitor the performance of the ZEUS Solinas Borrelia VlsE1/pepC10 IgG/IgM Test System. The performance characteristics of the ZEUS Solinas Borrelia VlsE1/pepC10 IgG/IgM Control Kit have not been established for any other assays or instrument platforms different from the ZEUS Solinas α instrument.

Device Story

Chemiluminescent immunoassay (CLIA) for qualitative detection of IgG/IgM antibodies to Borrelia burgdorferi in human serum; utilizes ZEUS Solinas instrument. Input: human serum samples. Process: automated immunoassay; detects antibodies via VlsE1/pepC10 antigens. Output: qualitative result indicating presence of antibodies. Used in clinical laboratory settings by trained personnel. Results support clinical diagnosis of Lyme disease when combined with patient history, symptoms, and supplemental STTT immunoblot testing. Negative results do not exclude infection.

Clinical Evidence

Clinical performance evaluated via CDC pre-market panel (N=280) and multi-site prospective study (N=1799). Prospective study compared subject device to predicate using STTT (immunoblot). PPA 95.81% (95% CI: 91.6–97.95%) and NPA 98.47% (95% CI: 97.75–98.96%) observed for STTT. CDC panel testing showed high sensitivity for late/neurologic Lyme and specificity for healthy/disease controls.

Technological Characteristics

Chemiluminescent immunoassay (CLIA) technology; utilizes VlsE1/pepC10 antigens for antibody detection; requires ZEUS Solinas instrument platform.

Indications for Use

Indicated for qualitative detection of IgG/IgM antibodies to Borrelia burgdorferi in human serum from patients with signs/symptoms of or suspected Lyme disease. Not for exclusion of Lyme disease. Requires supplemental testing with STTT immunoblot assay.

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). The logo consists of two parts: a symbol on the left and the text "FDA U.S. FOOD & DRUG ADMINISTRATION" on the right. The symbol on the left is the Department of Health & Human Services logo. The text is in blue, with "FDA" in a larger font size than the rest of the text.

July 13, 2023

ZEUS Scientific Mark Kopnitsky Chief Scientific Officer 200 Evans Way Branchburg, New Jersey 08876

Re: K230863

Trade/Device Name: ZEUS Solinas Borrelia VlsE1/pepC10 IgG/IgM Test System: ZEUS Solinas Borrelia VlsE1/pepC10 IgG/IgM Control Kit Regulation Number: 21 CFR 866.3830 Regulation Name: Treponema Pallidum Treponemal Test Reagents Regulatory Class: Class II Product Code: LSR, QCH Dated: March 27, 2023 Received: March 29, 2023

Dear Mark Kopnitsky:

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.

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

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

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 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,

# Noel J. Gerald -S

Noel J. Gerald, Ph.D. Branch Chief Bacterial Respiratory and Medical Countermeasures Branch Division of Microbiology Devices OHT7: Office of In Vitro Diagnostics Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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

## Indications for Use

510(k) Number (if known) K230863

Device Name

ZEUS Solinas Borrelia VlsE1/pepC10 IgG/IgM Test System ZEUS Solinas Borrelia VlsE1/pepC10 IgG/IgM Control Kit

#### Indications for Use (Describe)

The ZEUS Solinas Borrelia VIsE1/pepC10 IgG/IgM Test System uses chemiluminescent immunoassay (CLIA) technology for the qualitative detection of IgGlgM antibodies to Borrelia burgdorferi in human serum. This assay is intended for use on samples from patients with signs and symptoms consistent with or patients suspected of having Lyme disease to assess the presence of IgG/IgM antibodies.

Positive results with the ZEUS Solinas Borrelia VIsE1/pepC10 IgG/IgM Test System should be supplemented with additional testing with a Standard two-tier test (STTT) methodology using an IgG and/or IgM Borrelia burgdorferi immunoblot assay following current guidelines.

Positive supplemental results are supportive evidence of antibodies and exposure to Borrelia burgdorferi and may be used along with patient history, symptoms and other laboratory data to support a clinical diagnosis of Lyme disease.

Negative results by the ZEUS Solinas Borrelia VlsE1/pepC10 IgG/IgM Test System should not be used to exclude Lyme disease. The test must be performed on the ZEUS Solinas instrument.

The ZEUS Solinas Borrelia VIsE1/pepC10 IgG/IgM Control Kit is intended for use as assayed quality control samples to monitor the performance of the ZEUS Solinas Borrelia VlsE1/pepC10 IgG/IgM Test System. The performance characteristics of the ZEUS Solinas Borrelia VIsE1/pepC10 IgG/IgM Control Kit have not been established for any other assays or instrument platforms.

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) |

### 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."