EUROIMMUN IFA: Crithidia luciliae (anti-dsDNA) EUROPattern

K172244 · Euroimmun Us, Inc. · KTL · Apr 20, 2018 · Immunology

Device Facts

• Record ID: K172244
• Device Name: EUROIMMUN IFA: Crithidia luciliae (anti-dsDNA) EUROPattern
• Applicant: Euroimmun Us, Inc.
• Product Code: KTL · Immunology
• Decision Date: Apr 20, 2018
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.5100
• Device Class: Class 2

Intended Use

The EUROIMMUN IFA: Crithidia luciliae (anti-dsDNA) EUROPattern test kit is intended for the quantitative determination of human antibodies of immunoglobulin class IgG against anti-double stranded DNA (dsDNA) in human serum with the EUROPattern Microscope and Software automated instrument. It is used as an aid in the diagnosis of systemic lupus erythematosus (SLE), in conjunction with other laboratory and clinical findings. All suggested results obtained with the EUROPattern system must be confirmed by trained personnel.

Device Story

The device is an indirect immunofluorescence (IFA) assay using Crithidia luciliae substrate to detect anti-dsDNA antibodies in human serum. The test utilizes BIOCHIP slides containing Crithidia luciliae smears; patient samples are incubated on these slides, followed by incubation with fluorescein-labelled anti-human IgG conjugate. The EUROPattern Microscope and Software system captures fluorescence images of the kinetoplast. The software provides automated evaluation of fluorescence intensity and titer, which the operator must verify. The device is used in clinical laboratories to assist in SLE diagnosis. By identifying specific kinetoplast fluorescence, the system provides qualitative or semi-quantitative results that support clinical decision-making when combined with other laboratory and clinical findings.

Clinical Evidence

Clinical study evaluated 364 samples from patients with SLE and various differential diagnoses (AAV, PM/DM, SSc, SS, MCTD, RA, APS, DIL, AIH, AITD, HCV, CP, EBV). Sensitivity and specificity were assessed across three modes (A: automated, B: automated imaging/manual reading, C: manual). Overall sensitivity for SLE was 33.0% (Mode C) to 38.8% (Mode A), and specificity for non-SLE samples was 91.6% (Mode A) to 97.0% (Mode C). Analytical studies confirmed reproducibility and precision across sites and operators.

Technological Characteristics

The system comprises an automated fluorescence microscope and image analysis software. It uses the Crithidia luciliae substrate for IFA. The device is designed for the detection of IgG class antibodies. It operates as a networked or standalone automated workstation. The software performs image acquisition and pattern recognition to assist in the identification of anti-dsDNA antibodies.

Indications for Use

Indicated for the quantitative determination of IgG anti-dsDNA antibodies in human serum to aid in the diagnosis of systemic lupus erythematosus (SLE). For prescription use only. Results require confirmation by trained personnel.

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).

Predicate Devices

• Quanta Lite® dsDNA ELISA (K903898)

Submission Summary (Full Text)

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April 20, 2018

Euroimmun US, Inc. Daniel Castellanos Senior Regulatory Affairs and Quality Management 1 Bloomfield Avenue Mountain Lakes. New Jersey 07046

Re: K172244

Trade/Device Name: EUROIMMUN IFA: Crithidia luciliae (anti-dsDNA) EUROPattern Regulation Number: 21 CFR 866.5100 Regulation Name: Antinuclear antibody immunological test system Regulatory Class: Class II Product Code: KTL, PIV Dated: July 24, 2017 Received: July 26, 2017

Dear Daniel Castellanos:

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

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803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely.

# Kelly Oliner - S

For. Lea Carrington Director Division of Immunology and Hematology Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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#### DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

# Indications for Use

### 510(k) Number (if known) K172244

#### Device Name

EUROIMMUN IFA: Crithidia luciliae (anti-dsDNA) EUROPattern

# Indications for Use (Describe)

The EUROIMMUN IFA: Crithidia luciliae (anti-dsDNA) EUROPattern test kit is intended for the quantitative determination of human antibodies of immunoglobulin class IgG against anti-double stranded DNA (dsDNA) in human serum with the EUROPattern Microscope and Software automated instrument. It is used as an aid in the diagnosis of systemic lupus erythematosus (SLE), in conjunction with other laboratory and clinical findings. All suggested results obtained with the EUROPattern system must be confirmed by trained personnel.

Type of Use (Select one or both, as applicable)

X Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

# PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

#### FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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