THE APTUS (AUTOMATED) APPLICATION OF THE LEGIONELLA IGG/A/M (ELISA) TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (E

K984123 · Zeus Scientific, Inc. · LHL · Jan 11, 1999 · Microbiology

Device Facts

• Record ID: K984123
• Device Name: THE APTUS (AUTOMATED) APPLICATION OF THE LEGIONELLA IGG/A/M (ELISA) TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (E
• Applicant: Zeus Scientific, Inc.
• Product Code: LHL · Microbiology
• Decision Date: Jan 11, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.3300
• Device Class: Class 2

Intended Use

The Zeus Scientific, Inc. Legionella ELISA test system is and enzyme-linked immunosorbent assay for the manual or automated, qualitative detection of total antibody (IgGligMligA) to Legionella pneumophila Groups 1 - 6 in human serum. This test is for in vitro diagnostic use.

Device Story

The Aptus (automated) Application for the Legionella IgG/A/M ELISA Test System is an automated platform for performing enzyme-linked immunosorbent assays (ELISA). It processes human serum samples to detect antibodies against Legionella pneumophila Groups 1-6. The system automates the manual ELISA procedure, providing qualitative results to clinical laboratory personnel. By automating the assay, the device reduces manual handling, standardizes incubation and washing steps, and provides consistent output for clinical decision-making regarding Legionella infection diagnosis.

Clinical Evidence

No clinical data provided; substantial equivalence based on performance comparison between manual and automated ELISA processing methods.

Technological Characteristics

Enzyme-linked immunosorbent assay (ELISA) platform; automated liquid handling and incubation system; qualitative detection of antibodies; in vitro diagnostic use.

Indications for Use

Indicated for qualitative detection of total antibodies (IgG/IgM/IgA) to Legionella pneumophila Groups 1-6 in human serum for in vitro diagnostic use.

Regulatory Classification

Identification

Haemophilus spp. serological reagents are devices that consist of antigens and antisera, including antisera conjugated with a fluorescent dye, that are used in serological tests to identify Haemophilus spp. directly from clinical specimens or tissue culture isolates derived from clinical specimens. The identification aids in the diagnosis of diseases caused by bacteria belonging to the genus Haemophilus and provides epidemiological information on diseases cause by these microorganisms. Diseases most often caused by Haemophilus spp. include pneumonia, pharyngitis, sinusitis, vaginitis, chancroid venereal disease, and a contagious form of conjunctivitis (inflammation of eyelid membranes).

Special Controls

*Classification.* Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 866.9.

Submission Summary (Full Text)

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JAN 11 1999

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

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

K984123 Re:

> Trade Name: The Aptus (automated) Application of the Legionella IgG/A/M ELISA Test System Regulatory Class: II Product Code: 83LHL Dated: November 17, 1998 Received: November 18, 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 vours.

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): K984123

Page

Device Name: Aptus (automated) Application for the Legionella IgG/A/M ELISA Test System

Indications for Use:

The Zeus Scientific, Inc. Legionella ELISA test system is and enzyme-linked immunosorbent assay for the manual or automated, qualitative detection of total antibody (IgGligMligA) to Legionella pneumophila Groups 1 - 6 in human serum. This test is for in vitro diagnostic use.

Revised: 12-2-98

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use

OR

Over-The-Counter Use

(Per 21 CFR 801,109)

(Optional Format 1-

2-96)

Woody Debais

(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number K984123