THE APTUS (AUTOMATED) APPLICATION OF THE TOXOPLASMA IGM ELISA TEST SYSTEM

K984170 · Zeus Scientific, Inc. · LGD · Jan 19, 1999 · Microbiology

Device Facts

• Record ID: K984170
• Device Name: THE APTUS (AUTOMATED) APPLICATION OF THE TOXOPLASMA IGM ELISA TEST SYSTEM
• Applicant: Zeus Scientific, Inc.
• Product Code: LGD · Microbiology
• Decision Date: Jan 19, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.3780
• Device Class: Class 2
• Attributes: Software as a Medical Device

Intended Use

The Toxoplasma IgM ELISA test system provides a means for the manual and/or automated (Aptus), presumptive, qualitative determination of IgM-class antibody to T. gondii in human serum and for the presumptive diagnosos of acute, recent, or reactive infection. To adequately assess the patient's serological status, testing must be performed in conjunction with an anti-Toxoplasma gondii IgG antibody assay. This product is not FDA cleared (approved) for use in testing (i.e., screening) blood or plasma donors. The assay's performance has not been established for screening of prenatal women or newborns.

Device Story

The Aptus application is an automated software module for the Toxoplasma IgM ELISA test system. It processes optical density data from ELISA plate readers to determine the presence of IgM-class antibodies to T. gondii in human serum. Used in clinical laboratories by technicians; the system automates the calculation and interpretation of qualitative results based on established ELISA thresholds. The output provides clinicians with a presumptive diagnosis of acute or recent infection, which must be interpreted alongside IgG antibody results. The automation improves laboratory workflow efficiency and reduces manual calculation errors in diagnostic testing.

Clinical Evidence

No clinical data provided in the document; substantial equivalence is based on the performance of the underlying ELISA test system and the validation of the automated application's data processing capabilities.

Technological Characteristics

Automated software application for ELISA plate reader data processing. Operates as an add-on to existing Toxoplasma IgM ELISA test systems. Connectivity involves integration with standard laboratory ELISA instrumentation. Software-based qualitative interpretation of optical density measurements.

Indications for Use

Indicated for presumptive, qualitative determination of IgM-class antibody to T. gondii in human serum to aid in diagnosis of acute, recent, or reactive infection. Must be used with anti-Toxoplasma gondii IgG assay. Not for blood/plasma donor screening. Performance not established for prenatal or newborn screening.

Regulatory Classification

Identification

Toxoplasma gondii serological reagents are devices that consist of antigens and antisera used in serological tests to identify antibodies to Toxoplasma gondii in serum. Additionally, some of these reagents consist of antisera conjugated with a fluorescent dye (immunofluorescent reagents) used to identify Toxoplasma gondii from clinical specimens. The identification aids in the diagnosis of toxoplasmosis caused by the parasitic protozoan Toxoplasma gondii and provides epidemiological information on this disease. Congenital toxoplasmosis is characterized by lesions of the central nervous system, which if undetected and untreated may lead to brain defects, blindness, and death of an unborn fetus. The disease is characterized in children by inflammation of the brain and spinal cord.

Submission Summary (Full Text)

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Public Health Service

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

JAN 1 9 1999

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

Re: K984170

Trade Name: The Aptus (automated) Application for the Toxoplasma IgM ELISA Test System Regulatory Class: II

Product Code: LDG Dated: November 19, 1998 Received: November 20, 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 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 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 vours.

Steven Autman

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): И 984 l70

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

Indications for Use:

The Toxoplasma IgM ELISA test system provides a means for the manual and/or automated (Aptus), presumptive, qualitative determination of IgM-class antibody to T. gondii in human serum and for the presumptive diagnosos of acute, recent, or reactive infection. To adequately assess the patient's serological status, testing must be performed in conjunction with an anti-Toxoplasma gondii IgG antibody assay. This product is not FDA cleared (approved) for use in testing (i.e., screening) blood or plasma donors. The assay's performance has not been established for screening of prenatal women or newborns.

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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)

Woodes Dubois

nical I aboratory Devices 510(k) Number

(Optional Format 1-