THE APTUS (AUTOMATED) APPLICATION OF THE TOXOPLASMA IGG ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA)F

K984317 · Zeus Scientific, Inc. · LGD · Jan 22, 1999 · Microbiology

Device Facts

• Record ID: K984317
• Device Name: THE APTUS (AUTOMATED) APPLICATION OF THE TOXOPLASMA IGG ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA)F
• Applicant: Zeus Scientific, Inc.
• Product Code: LGD · Microbiology
• Decision Date: Jan 22, 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 IgG ELISA test system provides a means for the manual and/or automated (Aptus), qualitative determination of IgG-class antibody to T. gondii in human serum. The test system is intended to be used to evaluate serologic evidence of previous infection with T. gondli, and is for in vitro diagnostic use. This product is not FDA cleared (approved) for use in testing (i.e., screening) blood or plasma donors.

Device Story

The Aptus application is an automated software module for the Toxoplasma IgG ELISA test system. It processes optical density data from ELISA plate readers to determine the presence of IgG-class antibodies to T. gondii in human serum samples. Used in clinical laboratories, the system automates the calculation and interpretation of test results, which are then reviewed by laboratory personnel to assess patient serologic status regarding past T. gondii infection. The automation streamlines the workflow compared to manual processing, reducing potential for calculation errors and improving throughput in diagnostic settings.

Clinical Evidence

No clinical data provided; substantial equivalence is based on performance characteristics and comparison to manual testing methods.

Technological Characteristics

Automated software application for ELISA plate readers; performs qualitative analysis of optical density measurements for T. gondii IgG detection. Operates as an add-on to existing ELISA test systems.

Indications for Use

Indicated for qualitative determination of IgG-class antibodies to T. gondii in human serum to evaluate serologic evidence of previous infection. Not for use in screening blood or plasma donors.

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

JAN 22 1999

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

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

Re: K984317

> Trade Name: The Aptus (automated) Application for the Toxoplasma IgG ELISA Test System Regulatory Class: II Product Code: LGD Dated: December 2, 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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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 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): ____________________________________________________________________________________________________________________________________________________

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

Indications for Use:

The Toxoplasma IgG ELISA test system provides a means for the manual and/or automated (Aptus), qualitative determination of IgG-class antibody to T. gondii in human serum. The test system is intended to be used to evaluate serologic evidence of previous infection with T. gondli, and is for in vitro diagnostic use. This product is not FDA cleared (approved) for use in testing (i.e., screening) blood or plasma donors.

(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

(Per 21 CFR 801,109)

2-96)

Woody Dubois

(Optional Format 1-

510(k) Number

20