THE APTUS (AUTOMATED) APPLICATION OF THE PR-3 ELISA TEST SYSTEM. AN ANEYME LINKED IMMUNOSORBENT ASSAY (ELISA) FOR THE DE

K984315 · Zeus Scientific, Inc. · MOB · Dec 17, 1998 · Immunology

Device Facts

• Record ID: K984315
• Device Name: THE APTUS (AUTOMATED) APPLICATION OF THE PR-3 ELISA TEST SYSTEM. AN ANEYME LINKED IMMUNOSORBENT ASSAY (ELISA) FOR THE DE
• Applicant: Zeus Scientific, Inc.
• Product Code: MOB · Immunology
• Decision Date: Dec 17, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.5660
• Device Class: Class 2

Intended Use

The Zeus Scientfic, Inc. PR-3 ELISA test system is intended for the semi-quantitative detection of IgGclass antibody to proteinase-3 in human serum. The test system is intended to be used as an automated or manual aid in the diagnosis of various autoimmune vasculitic disorders characterized by elevated levels of antibodies to PR-3. Elevated antibody levels to PR-3 may be associated with autoimmune disorders such as Wegener's Granulamotosis, Idiopathic Crescentic Glomerulonephritis, Microscopic Polyarteritis, and Pulmonary Renal Syndrome. This test is for in vitro diagnostic use.

Device Story

Aptus (Automated) PR-3 ELISA Test System is an in vitro diagnostic assay for detecting IgG antibodies to proteinase-3 in human serum. The system supports both manual and automated processing. It functions as an aid in diagnosing autoimmune vasculitic disorders by identifying elevated PR-3 antibody levels. Clinicians use the semi-quantitative results to support clinical assessment of conditions like Wegener's Granulomatosis and related vasculitis. The device is intended for professional laboratory use.

Clinical Evidence

No clinical data provided in the document; substantial equivalence determination based on 510(k) regulatory review.

Technological Characteristics

ELISA (Enzyme-Linked Immunosorbent Assay) test system for semi-quantitative detection of IgG antibodies. Supports both manual and automated operational modes.

Indications for Use

Indicated for semi-quantitative detection of IgG class antibodies to proteinase-3 (PR-3) in human serum. Used as an aid in diagnosing autoimmune vasculitic disorders, including Wegener's Granulomatosis, Idiopathic Crescentic Glomerulonephritis, Microscopic Polyarteritis, and Pulmonary Renal Syndrome. For in vitro diagnostic use.

Regulatory Classification

Identification

A multiple autoantibodies immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the autoantibodies (antibodies produced against the body's own tissues) in serum and other body fluids. Measurement of multiple autoantibodies aids in the diagnosis of autoimmune disorders (disease produced when the body's own tissues are injured by autoantibodies).

Submission Summary (Full Text)

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## DEC 1 7 1998

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

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

Re: K984315 Aptus (Automated) Application for the PR-3 ELISA Trade Name: Test System Regulatory Class: II Product Code: MOB Dated: December 1, 1998 Received: December 3, 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 additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, 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 regulation may result in regulatory 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 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 diaqnostic 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 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 Sutman

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

Enclosure

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510(k) Number (if known): 长984315

Aptus (automated) Application for the PR-3 ELISA Test Device Name: System

## Indications for Use:

The Zeus Scientfic, Inc. PR-3 ELISA test system is intended for the semi-quantitative detection of IgGclass antibody to proteinase-3 in human serum. The test system is intended to be used as an automated or manual aid in the diagnosis of various autoimmune vasculitic disorders characterized by elevated levels of antibodies to PR-3. Elevated antibody levels to PR-3 may be associated with autoimmune disorders such as Wegener's Granulamotosis, Idiopathic Crescentic Glomerulonephritis, Microscopic Polyarteritis, and Pulmonary Renal Syndrome. This test is for in vitro diagnostic use.

Peter E. Maleni

Division Sion-

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use

✓

OR

Over-The-Counter Use

(Optional Format 1-

(Per 21 CFR 801.109)

2-96)