EUROIMMUN ANA IFA: HEP-20-10

K070763 · Euroimmun Us, LLC · DHN · May 22, 2007 · Immunology

Device Facts

• Record ID: K070763
• Device Name: EUROIMMUN ANA IFA: HEP-20-10
• Applicant: Euroimmun Us, LLC
• Product Code: DHN · Immunology
• Decision Date: May 22, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.5100
• Device Class: Class 2

Intended Use

This is an indirect immunofluorescent antibody test for the qualitative or semi-quantitative detection of antinuclear antibodies (ANA) in human serum and EDTA plasma. This test is used as an aid in the diagnosis of systemic rheumatic diseases in conjunction with other laboratory and clinical findings.

Device Story

The EUROIMMUN ANA IFA:HEp-20-10 is an indirect fluorescent antibody (IFA) test kit. It utilizes HEp-20-10 cells as a substrate to detect antinuclear antibodies (ANA) in patient serum or EDTA-plasma samples. The device is intended for use in clinical laboratory settings by trained laboratory personnel. The process involves incubating patient samples with the substrate, followed by the addition of a fluorescently labeled conjugate. Results are visualized via fluorescence microscopy. The presence and pattern of fluorescence are interpreted by the clinician to aid in the diagnosis of systemic rheumatic diseases, alongside other clinical and laboratory findings.

Clinical Evidence

No clinical data provided in the document; substantial equivalence is based on the device's technological characteristics and intended use as an in vitro diagnostic test.

Technological Characteristics

Indirect fluorescent antibody (IFA) test system using HEp-20-10 cell substrate. Qualitative or semiquantitative detection of ANA in human serum or EDTA-plasma. Class II device, product code DHN.

Indications for Use

Indicated for qualitative or semiquantitative detection of antinuclear antibodies (ANA) in human serum and EDTA-plasma to aid in the diagnosis of systemic rheumatic diseases.

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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Food and Drug Administration 2098 Gaither Road Rockville MD 20850

EUROIMMUN US, LLC c/o Ms. Kathryn Kohl Managing Director 429 Rockaway Valley Road, Unit 1200 Boonton Township, New Jersey 07005

MAY 2 2 2007

Re: k070763

Trade/Device Name: EUROIMMUN ANA IFA : Hep-20-10 Regulation Number: 21 CFR 866.5100 Regulation Name: Antinuclear Antibody, Immunological Test System Regulatory Class: Class II Product Code: DHN Dated: March 19, 2007 Received: March 20, 2007

Dear Ms. Kohl:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), 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 good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The

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FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Robert Z. Beckock

Robert L. Becker, Jr., M.D., Ph.D. Director Division of Immunology and Hematology Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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## | EUROIMMUN US, LLC

Σ Σ Σ Σ Σ

## ATTACHMENT 1

## INDICATIONS FOR USE STATEMENT

510(k) Number (if known): k070763

Device Name: ANA IFA: HEp-20-10 Kit

Indications For Use:

The EUROIMMUN ANA IFA:HEp-20-10 is an indirect fluorescent antibody test for the qualitative or semiquantitative detection of antibodies against cell nuclei (ANA) in human serum and EDTA-plasma. This test system is used as an aid in the diagnosis of systemic rheumatic diseases in conjunction with other laboratory and clinical findings.

Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR

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

(PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (OIVD)

Robert Z. Bednar
Division Sign-Off

K670763