ZEUS IFA(TM) nDNA Test System, ZEUS dIFine

K231616 · Zeus Scientific · KTL · Aug 31, 2023 · Immunology

Device Facts

• Record ID: K231616
• Device Name: ZEUS IFA(TM) nDNA Test System, ZEUS dIFine
• Applicant: Zeus Scientific
• Product Code: KTL · Immunology
• Decision Date: Aug 31, 2023
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.5100
• Device Class: Class 2

Intended Use

The ZEUS IFA™ nDNA Test System is an indirect immunofluorescence assay utilizing Crithidia luciliae for the qualitative and semi-quantitative determination of anti-native DNA (nDNA) IgG antibodies to DNA in human serum by manual fluorescence microscopy or with ZEUS dIFine®. The presence of nDNA antibodies in conjunction with other serological and clinical findings can be used to aid in the diagnosis of systemic lupus erythematosus (SLE).

Device Story

The ZEUS IFA nDNA Test System is an indirect immunofluorescence assay (IFA) using Crithidia luciliae substrate to detect anti-native DNA (nDNA) IgG antibodies in human serum. The device is used in clinical laboratories by trained personnel. Samples are incubated with the substrate; if nDNA antibodies are present, they bind to the kinetoplast of the Crithidia luciliae. Bound antibodies are detected using a fluorescently labeled anti-human IgG conjugate. Results are visualized via manual fluorescence microscopy or processed using the ZEUS dIFine® automated system. The output provides qualitative or semi-quantitative antibody levels, which clinicians use alongside other serological and clinical data to support a diagnosis of systemic lupus erythematosus (SLE).

Clinical Evidence

Clinical performance was evaluated using 660 clinically characterized samples (300 SLE, 360 non-SLE controls). Sensitivity and specificity were compared across three methods. Sensitivity for SLE ranged from 22.33% to 27.00% across methods and sites. Specificity ranged from 97.50% to 99.72%. Method comparison studies (N=3,960 comparisons) showed high agreement between manual and automated methods, with overall agreement between Method A and Method C (UNC as positive) at 98.31% (95% CI: 97.86%–98.66%).

Technological Characteristics

Indirect immunofluorescence assay using C. luciliae substrate slides. Reagents include FITC-labeled goat anti-human IgG conjugate, positive/negative human serum controls, and PBS. ZEUS dIFine system uses a 20X objective to capture 12 fields of view (approx. 610 µm x 510 µm) per well. Software performs automated image analysis and fluorescence intensity measurement. System is intended for clinical laboratory use.

Indications for Use

Indicated for qualitative and semi-quantitative detection of anti-native DNA (nDNA) IgG antibodies in human serum to aid in the diagnosis of systemic lupus erythematosus (SLE). For use by trained operators in clinical laboratory settings. Prescription use only.

Regulatory Classification

Identification

An antinuclear antibody immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the autoimmune antibodies in serum, other body fluids, and tissues that react with cellular nuclear constituents (molecules present in the nucleus of a cell, such as ribonucleic acid, deoxyribonucleic acid, or nuclear proteins). The measurements aid in the diagnosis of systemic lupus erythematosus (a multisystem autoimmune disease in which antibodies attack the victim's own tissues), hepatitis (a liver disease), rheumatoid arthritis, Sjögren's syndrome (arthritis with inflammation of the eye, eyelid, and salivary glands), and systemic sclerosis (chronic hardening and shrinking of many body tissues).

Submission Summary (Full Text)

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Image /page/0/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, with the letters "FDA" in a blue square. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

August 31, 2023

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

Re: K231616

Trade/Device Name: ZEUS IFA nDNA Test System Regulation Number: 21 CFR 866.5100 Regulation Name: Antinuclear Antibody Immunological Test System Regulatory Class: Class II Product Code: KTL, PIV Dated: Mav 31, 2023 Received: June 2, 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

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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,

Ying Mao -S

Ying Mao, Ph.D. Branch Chief Division of Immunology and Hematology Devices OHT7: Office of In Vitro Diagnostics Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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## Indications for Use

510(k) Number (if known) K231616

Device Name ZEUS IFA nDNA Test System

## Indications for Use (Describe)

The ZEUS IFA™ nDNA Test System is an indirect immunofluorescence assay utilizing Crithidia luciliae for the qualitative and semi-quantitative determination of anti-native DNA (nDNA) IgG antibodies to DNA in human serum by manual fluorescence microscopy or with ZEUS dIFine®. The presence of nDNA antibodies in conjunction with other serological and clinical findings can be used to aid in the diagnosis of systemic lupus erythematosus (SLE).

| Type of Use (Select one or both, as applicable) |
|-----------------------------------------------------------------------------------------------------------|
| <span> <span style="font-size: 16px;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) </span> |
| <span> <span style="font-size: 16px;">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) </span> |

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