THE APTUS (AUTOMATED) APPLICATION OF THE CMV IGM ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) FOR THE

K983803 · Zeus Scientific, Inc. · LFZ · Dec 14, 1998 · Microbiology

Device Facts

• Record ID: K983803
• Device Name: THE APTUS (AUTOMATED) APPLICATION OF THE CMV IGM ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) FOR THE
• Applicant: Zeus Scientific, Inc.
• Product Code: LFZ · Microbiology
• Decision Date: Dec 14, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.3175
• Device Class: Class 2

Intended Use

The CMV IgM ELISA test system is and enzyme-linked immunosorbent assay (ELISA) designed for the manual or automated (Aptus) qualitative determination of IgM antibodies to cytomegalovirus in human serum. The test is intended to be used to evaluate serologic evidence of primary or reactivated infection with CMV and is for in vitro diagnostic use. This product is not FDA deared (approved) for use in testing (i.e., screening) blood or plasma donors.

Device Story

Aptus is an automated system for performing CMV IgM ELISA tests; processes human serum samples to detect IgM antibodies; utilizes enzyme-linked immunosorbent assay technology; intended for clinical laboratory use; provides qualitative results to clinicians to aid in diagnosing primary or reactivated CMV infection; supports both manual and automated workflows.

Technological Characteristics

Enzyme-linked immunosorbent assay (ELISA) for qualitative detection of IgM antibodies; automated or manual processing; in vitro diagnostic use.

Indications for Use

Indicated for qualitative determination of IgM antibodies to cytomegalovirus in human serum to evaluate serologic evidence of primary or reactivated CMV infection. Not for screening blood or plasma donors.

Regulatory Classification

Identification

Cytomegalovirus serological reagents are devices that consist of antigens and antisera used in serological tests to identify antibodies to cytomegalovirus in serum. The identification aids in the diagnosis of diseases caused by cytomegaloviruses (principally cytomegalic inclusion disease) and provides epidemiological information on these diseases. Cytomegalic inclusion disease is a generalized infection of infants and is caused by intrauterine or early postnatal infection with the virus. The disease may cause severe congenital abnormalities, such as microcephaly (abnormal smallness of the head), motor disability, and mental retardation. Cytomegalovirus infection has also been associated with acquired hemolytic anemia, acute and chronic hepatitis, and an infectious mononucleosis-like syndrome.

Submission Summary (Full Text)

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DEC 1 4 1998

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Mark J. Kopnitsky Vice President of Research & Development Zeus Scientific, Inc. P.O. Box 38 Raritan, NJ 08869

Re: K983803 Trade Name: Aptus (Automated) Application of the CMV IgM ELISA Test Regulatory Class: II Product Code: LFZ Dated: October 22, 1998 Received: October 28, 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 (OS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic OS 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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Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA-88), this device may require a CLIA complexity categorization. To determine if it does, you should contact the Centers for Disease Control and Prevention (CDC) at [phone].

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 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 at [phone] or at its internet address "http://www.fda.gov/cdrh/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): ____________________________________________________________________________________________________________________________________________________

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

## Indications for Use:

The CMV IgM ELISA test system is and enzyme-linked immunosorbent assay (ELISA) designed for the manual or automated (Aptus) qualitative determination of IgM antibodies to cytomegalovirus in human serum. The test is intended to be used to evaluate serologic evidence of primary or reactivated infection with CMV and is for in vitro diagnostic use. This product is not FDA deared (approved) for use in testing (i.e., screening) blood or plasma donors.

Revised 11-19-98

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use

OR

Over-The-Counter Use

(Per 21 CFR 801,109)

2-96)

Wooley Dubois

(Optional Format 1-

Division of Clinical Laboratory Devices
510(k) Number K983803