EUROIMMUN ANTI-DSDNA-NCX ELISA (IGG)

K083381 · Euroimmun Us, Inc. · LRM · Apr 15, 2009 · Immunology

Device Facts

• Record ID: K083381
• Device Name: EUROIMMUN ANTI-DSDNA-NCX ELISA (IGG)
• Applicant: Euroimmun Us, Inc.
• Product Code: LRM · Immunology
• Decision Date: Apr 15, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.5100
• Device Class: Class 2

Intended Use

The EUROIMMUN Anti-dsDNA-NcX ELISA (IgG) test kit is designed for the quantitative or semi-quantitative determination of IgG class autoantibodies against double-stranded genomic DNA (dsDNA) in human serum and plasma. It is used as an aid in the diagnosis of systemic lupus erythematosus, in conjunction with other laboratory and clinical findings.

Device Story

The EUROIMMUN Anti-dsDNA-NcX ELISA (IgG) is an in vitro diagnostic test kit used in clinical laboratory settings by trained personnel. It detects IgG autoantibodies against double-stranded genomic DNA (dsDNA) in human serum or plasma samples. The device utilizes an enzyme-linked immunosorbent assay (ELISA) principle; patient samples are incubated in wells coated with dsDNA-NcX antigen. If specific IgG antibodies are present, they bind to the antigen. After washing, an enzyme-labeled secondary antibody is added, followed by a substrate to produce a colorimetric signal proportional to the antibody concentration. Results are interpreted by healthcare providers alongside clinical findings to aid in the diagnosis of systemic lupus erythematosus (SLE).

Clinical Evidence

No clinical data provided in the document; substantial equivalence is based on bench testing and performance characteristics typical of ELISA-based immunological test systems.

Technological Characteristics

ELISA-based immunoassay; utilizes microplate wells coated with dsDNA-NcX antigen; detects IgG class autoantibodies; colorimetric detection via enzyme-labeled secondary antibody; in vitro diagnostic kit format.

Indications for Use

Indicated for the quantitative or qualitative detection of IgG autoantibodies against dsDNA in human serum, EDTA plasma, or citrate plasma to aid in the diagnosis of systemic lupus erythematosus (SLE).

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

## APR 1 5 2009

EUROIMMUN US Inc. c/o Ms. Kathryn Kohl Managing Director 95 Washington St Morristown, NJ 07960

Re: k083381

Trade/Device Name: EUROIMMUN Anti-dsDNA-NcX ELISA (IgG) Regulation Number: 21 CFR 866.5100 Regulation Name: Antinuclear Antibody Immunological Test System Regulatory Class: Class II Product Code: LRM Dated: March 26, 2009 Received: April 3, 2009

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 895. In addition, FDA mav 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 Parts 801 and 809); 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 FDA finding

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Page 2 - Ms. Kathryn Kohl

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 advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at 240-276-0450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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,

Tharai M. Chan

Maria M. Chan, 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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## INDICATIONS FOR USE STATEMENT

510(k) Number (if known): K083381

Device Name: Anti-dsDNA-NcX ELISA (IgG)

Indications For Use:

The EUROIMMUN Anti-dsDNA-NcX ELISA (IgG) test kit is designed for the quantitative or qualitative determination of IgG class autoantibodies against double-stranded genomic DNA (dsDNA) in human serum and EDTA or citrate plasma. It is used as an aid in the diagnosis of systemic lupus erythematosus, 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)

ia m chon

**Division Sign-Off**

Office of In Vitro Diagnostic Device Evaluation and Sa

510(k) K083381