THE APTUS(AUTOMATED)APPLICATION OF THE RHEUMATOID FACTOR IGM ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY(EL

K983418 · Zeus Scientific, Inc. · DHR · Nov 18, 1998 · Immunology

Device Facts

• Record ID: K983418
• Device Name: THE APTUS(AUTOMATED)APPLICATION OF THE RHEUMATOID FACTOR IGM ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY(EL
• Applicant: Zeus Scientific, Inc.
• Product Code: DHR · Immunology
• Decision Date: Nov 18, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.5775
• Device Class: Class 2

Intended Use

The Zeus Scientific, Inc. Rheumatoid Factor IgM ELISA test system is intended for the qualitative and semi-quantitative detection of RF IgM class antibody in human serum. The test system is intended for the manual or automated analysis of human serum for the presence of IgM RF. The test system is intended to be used as aid in the diagnosis of rheumatoid arthritis. The test is for in vitro diagnostic use.

Device Story

The Aptus (Automated) Rheumatoid Factor IgM ELISA Test System is an in vitro diagnostic assay designed to detect IgM class rheumatoid factor antibodies in human serum. The device utilizes an enzyme-linked immunosorbent assay (ELISA) format, which can be performed manually or via automated laboratory instrumentation. By measuring the presence and concentration of IgM RF, the test provides clinical information to assist healthcare providers in the diagnosis of rheumatoid arthritis. The system is intended for use in clinical laboratory settings by trained laboratory personnel. The output, provided as qualitative or semi-quantitative results, supports clinical decision-making regarding the evaluation of patients presenting with symptoms of rheumatoid arthritis.

Clinical Evidence

No clinical data provided in the document; the submission relies on substantial equivalence to existing legally marketed devices.

Technological Characteristics

ELISA-based immunoassay for the detection of IgM class antibodies. The system supports both manual and automated processing. It is an in vitro diagnostic device intended for laboratory use.

Indications for Use

Indicated for the qualitative and semi-quantitative detection of IgM class rheumatoid factor (RF) antibodies in human serum to aid in the diagnosis of rheumatoid arthritis. For in vitro diagnostic use.

Regulatory Classification

Identification

A rheumatoid factor immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the rheumatoid factor (antibodies to immunoglobulins) in serum, other body fluids, and tissues. Measurement of rheumatoid factor may aid in the diagnosis of rheumatoid arthritis.

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 08876 Branchburg, New Jersey

K983418 Re : Trade Name: Aptus (Automated) Application for the RF Test System Requlatory Class: II Product Code: DHR Dated: September 28, 1998 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 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 (Premarket Approval), it may be subject to such Existing major regulations affecting your device additional controls. 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 Requlation (QS) for Medical Devices: General requlation (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 regulation may result in requlatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obliqation 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 requlation entitled, "Misbranding by reference to premarket notification"(21 CFR 807.97). Other general 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 Putman

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): _ K983418

Aptus (automated) Application for the Rheumatoid Factor Device Name: IgM ELISA Test System

Indications for Use:

The Zeus Scientific, Inc. Rheumatoid Factor IgM ELISA test system is intended for the qualitative and semi-quantitative detection of RF IgM class antibody in human serum. The test system is intended for the manual or automated analysis of human serum for the presence of IgM RF. The test system is intended to be used as aid in the diagnosis of rheumatoid arthritis. The test is for in vitro diagnostic use.

Revised: 11/06/98

Peter E. Makeri

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use /

OR

Over-The-Counter Use

(Per 21 CFR 801,109)

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2-96)