THE APTUS (AUTOMATED) APPLICATIONS OF THE DS DNA ELISA TEST SYSTEM LINKED IMMUNOSORBENT ASSAY(ELISA)FOR THE DET

K983422 · Zeus Scientific, Inc. · LRM · Nov 18, 1998 · Immunology

Device Facts

• Record ID: K983422
• Device Name: THE APTUS (AUTOMATED) APPLICATIONS OF THE DS DNA ELISA TEST SYSTEM LINKED IMMUNOSORBENT ASSAY(ELISA)FOR THE DET
• Applicant: Zeus Scientific, Inc.
• Product Code: LRM · Immunology
• Decision Date: Nov 18, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.5100
• Device Class: Class 2

Intended Use

The dsDNA ELISA test system is intended for the manual or automated analysis of human serum for the presence or absence of IgG antibodies dsDNA.

Device Story

The Aptus (Automated) dsDNA ELISA Test System is an in vitro diagnostic device used to detect IgG antibodies to double-stranded DNA (dsDNA) in human serum. The system supports both manual and automated analysis workflows. It is intended for use in clinical laboratory settings by trained laboratory personnel. By identifying the presence or absence of these autoantibodies, the device assists clinicians in the diagnostic work-up of patients suspected of having autoimmune connective tissue diseases. The output provides qualitative or semi-quantitative data regarding antibody presence, which clinicians use in conjunction with other clinical findings to support a diagnosis.

Clinical Evidence

No clinical data provided; the submission relies on the established utility of autoantibody detection in the diagnostic work-up of connective tissue diseases.

Technological Characteristics

ELISA (Enzyme-Linked Immunosorbent Assay) test system; supports manual or automated processing; intended for in vitro diagnostic use.

Indications for Use

Indicated for the analysis of human serum to detect IgG antibodies to dsDNA in patients with suspected connective tissue 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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## NOV 1 8 1998

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Mr. Mark J. Kopnitsky Vice President of Research & Development Zeus Scientific, Inc. 200 Evans Way Branchburg, New Jersey 08876

Re: K983422 Aptus (Automated) Application for the dsDNA Test Trade Name: System Regulatory Class: II Product Code: LRM September 28, 1998 Dated: Received: September 29, 1998

Dear Mr. Kopnitsky:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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 reqistration, 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Eederal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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This letter will allow you to begin marketing your device as described in your 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 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other qeneral information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone], or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

Steven Sutman

Steven I. Gutman, M.D., M.B.A. Director Division of Clinical Laboratory Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known): 1993422

Aptus (automated) Application for the dsDNA ELISA Test Device Name: System

Indications for Use:

The presence of autoantibodies to a number of nuclear constituents has proven to be useful in the diagnosis of various connective tissue diseases. Although the exact etiology of autoimmune diseases is unknown, and the specific role played by autoantibodies in the onset of various autoimmune connective tissue diseases is obscure, the association and frequency of detection of these antibodies may play a key role in the diagnostic work-up of patients with suspected connective tissue diseases.

The dsDNA ELISA test system is intended for the manual or automated analysis of human serum for the presence or absence of IgG antibodies dsDNA.

Peter E. Macleod

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use V

OR

Over-The-Counter Use

(Per 21 CFR 801,109)

2-96)

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