MYCOPLASMA IGM ELISA TEST SYSTEM

K971503 · Zeus Scientific, Inc. · LJZ · Aug 20, 1997 · Microbiology

Device Facts

• Record ID: K971503
• Device Name: MYCOPLASMA IGM ELISA TEST SYSTEM
• Applicant: Zeus Scientific, Inc.
• Product Code: LJZ · Microbiology
• Decision Date: Aug 20, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.3375
• Device Class: Class 1

Intended Use

The test system provides a means for the qualitative detection of IgM-class antibody to M. pneumoniae in adult human serum. The test system is for in vitro diagnostic use.

Device Story

The Zeus Scientific Mycoplasma IgM ELISA Test System is an in vitro diagnostic assay used to detect IgM-class antibodies against Mycoplasma pneumoniae in adult human serum. The device utilizes Enzyme-Linked Immunosorbent Assay (ELISA) technology to identify the presence of specific antibodies. It is intended for use by clinical laboratory professionals to assist in the diagnosis of M. pneumoniae-associated respiratory infections in symptomatic patients. The test provides qualitative results that aid clinicians in determining the patient's serological status, supporting clinical decision-making regarding the management of respiratory illness.

Clinical Evidence

No clinical data provided in the document.

Technological Characteristics

ELISA-based in vitro diagnostic test system for qualitative detection of IgM-class antibodies. Operates via immunological binding principles. Intended for professional laboratory use.

Indications for Use

Indicated for the qualitative detection of IgM-class antibodies to M. pneumoniae in adult human serum to aid in the diagnosis of disease associated with M. pneumoniae in patients presenting with clinical symptoms such as malaise, fever, cough, and sore throat.

Regulatory Classification

Identification

Mycoplasma spp. serological reagents are devices that consist of antigens and antisera used in serological tests to identify antibodies to Mycoplasma spp. in serum. Additionally, some of these reagents consist of Mycoplasma spp. antisera conjugated with a fluorescent dye (immunofluorescent reagents) used to identify Mycoplasma spp. directly from clinical specimens. The identification aids in the diagnosis of disease caused by bacteria belonging to the genus Mycoplasma and provides epidemiological information on diseases caused by these microorganisms. Mycoplasma spp. are associated with inflammatory conditions of the urinary and respiratory tracts, the genitals, and the mouth. The effects in humans of infection with Mycoplasma pneumoniae range from inapparent infection to mild or severe upper respiratory disease, ear infection, and bronchial pneumonia.

Submission Summary (Full Text)

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Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Mark J. Kopnitsky Research and Development Zeus Scientific, Inc. P.O. Box 38 . . . . . . . Raritan, New Jersey 08869

AUG 20 1997

Re: K971503 Trade Name: Mycoplasma IgM ELISA Test System Regulatory Class: I Product Code: LJZ Dated: July 8, 1997 Received: July 10, 1997

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 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): | K971503 |
|---------------------------|---------------------------------------------------|
| Device Name: | Zeus Scientific Mycoplasma IgM ELISA Test System. |

Indications For UseMycoplasma IgM ELISA test system; K971503

M. pneumoniae is the simplest self-replicating microorganism known. It is primarily a w. proumoman and is one of the most common causes of pneumonia and respiratory tract purrogen, and . Clinical signs of the onset of illness are gradual and uppor roophatory tract international malaise, and fever, cough is prominent, and sore throat is frequent.

For patients presenting such clinical symptoms, this test system may aid in the r or pationto provent's serological status, and therefore, may aid in the diagnosis of disease associated with M. pneumoniae. The test system provides a means for the qualitative detection of IgM-class antibody to M. pneumoniae in adult human serum. The test system is for in vitro diagnostic use.

Rev: 8/6/97

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Wm. Poole for Arleen F. Runkos

Division Sign-Off) Division of Clinical Laboratory Devices 1503 510(k) Number

Prescription Use
(Per 21 CFR 801.109)

OR

Over-The-Counter Use