IMMULISA DSDNA ANTIBODY ELISA

K101319 · Immco Diagnostics, Inc. · LRM · Dec 9, 2010 · Immunology

Device Facts

• Record ID: K101319
• Device Name: IMMULISA DSDNA ANTIBODY ELISA
• Applicant: Immco Diagnostics, Inc.
• Product Code: LRM · Immunology
• Decision Date: Dec 9, 2010
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.5100
• Device Class: Class 2
• Attributes: 3rd-Party Reviewed

Intended Use

An enzyme-linked immunosorbent assay (ELISA) for the detection and semi-quantitation of IgG antibodies to double stranded DNA (dsDNA) in human serum, as an aid in the diagnosis of systemic lupus erythematosus (SLE) in conjunction with other laboratory and clinical findings.

Device Story

ImmuLisa™ dsDNA Antibody ELISA is an in vitro diagnostic test for human serum samples. It utilizes enzyme-linked immunosorbent assay (ELISA) technology to detect and semi-quantitate IgG antibodies against double-stranded DNA. The assay is performed in a clinical laboratory setting by trained personnel. The device provides a semi-quantitative result that assists clinicians in the diagnosis of systemic lupus erythematosus (SLE). Results are interpreted alongside other clinical findings and laboratory data to support patient management decisions.

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. Components: recombinant dsDNA-coated microplate, HRP-labeled goat anti-human IgG conjugate, TMB substrate, H2SO4 stop solution. Requires ELISA microplate reader (450nm) and automated washer. Standardized to WHO Reference Reagent Wo/80. Storage 2-8°C. Qualitative and semi-quantitative interpretation.

Indications for Use

Indicated for the detection and semi-quantitation of IgG antibodies to dsDNA in human serum to aid in the diagnosis of systemic lupus erythematosus (SLE). For 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).

Predicate Devices

• Not specified

Submission Summary (Full Text)

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Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-0609 Silver Spring, MD 20993-0002

IMMCO Diagnostics c/o Mr. William J. Sammons Sr. Project Manager - Medical Devices Intertek Testing Services 2307 East Aurora Rd. Unit B7 Twinsburg, OH 44087

DEC 0 9 2010

Re: k101319

Trade/Device Name: ImmuLisa™ dsDNA Antibody ELISA Regulation Number: 21 CFR §866.5100 Regulation Name: Antinuclear Antibody Immunological Test System Regulatory Class: Class II Product Codes: LRM Dated: December 2, 2010 Received: December 3, 2010

Dear Mr. Sammons:

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 class II (Special Controls), 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 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

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Page 2 – Mr. William J. Sammons

CFR Part 807); labeling (21 CFR Parts 801 and 809); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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 of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device of your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Parts 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation (21 CF N Parts of I [phone]. 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.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its tolli the [phone] or [phone] or at its Internet address. http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours.

.maria 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

510(k) Number (if known): K\(01319

DEC 0 9 2010

Device Name:

ImmuLisa™ dsDNA Antibody ELISA

Indications For Use:

An enzyme linked immunosorbent assay (ELISA) for the detection and semi-quantitation of IgG antibodies to double stranded DNA (dsDNA) in human serum, as an aid in the diagnosis of systemic lupus erythematosus (SLE) in conjunction with other laboratory and clinical findings.

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

Over-The-Counter Use (Part 21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Reena Philip

**Division Sign-Off**

Office of In Vitro Diagnostic Device Evaluation and Safety

510K k101319