MYCOPLASMA IGG ELISA TEST SYSTEM

K970150 · Zeus Scientific, Inc. · LJZ · Jun 16, 1997 · Microbiology

Device Facts

• Record ID: K970150
• Device Name: MYCOPLASMA IGG ELISA TEST SYSTEM
• Applicant: Zeus Scientific, Inc.
• Product Code: LJZ · Microbiology
• Decision Date: Jun 16, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.3375
• Device Class: Class 1
• Attributes: Pediatric

Intended Use

Mycoplasma IgG ELISA test system; K970150 M. pneumoniae is the simplest self-replicating microorganism known. It is primarily a respiratory tract pathogen, and is one of the most common causes of pneumonia and upper-respiratory tract infections. Symptomatic infections attributable to this organism most commonly occur in children and young adults; however, the elderly may also be at risk. Clinical signs of the onset of illness are gradual and characterized by headache, malaise, and fever; cough is prominent, and sore throat is frequent. For patients presenting such clinical symptoms, this test system may aid in the determination of the patient'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 IgG-class antibody to M. pneumoniae in human serum. The test system is for in vitro diagnostic use.

Device Story

The Mycoplasma IgG ELISA Test System is an in vitro diagnostic assay used to detect IgG-class antibodies against M. pneumoniae in human serum. The device utilizes Enzyme-Linked Immunosorbent Assay (ELISA) technology. It is intended for use in clinical laboratory settings by trained laboratory personnel. The test provides qualitative results that assist healthcare providers in determining the serological status of patients exhibiting symptoms of respiratory tract infections, such as pneumonia. By identifying the presence of specific IgG antibodies, the test aids in the clinical diagnosis of M. pneumoniae infections, supporting appropriate patient management decisions.

Technological Characteristics

ELISA (Enzyme-Linked Immunosorbent Assay) test system for qualitative detection of IgG-class antibodies in human serum. In vitro diagnostic device.

Indications for Use

Indicated for qualitative detection of IgG-class antibodies to M. pneumoniae in human serum to aid in the diagnosis of M. pneumoniae-associated disease in patients presenting with clinical symptoms of respiratory infection (e.g., headache, malaise, fever, cough, 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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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration
2098 Gaither Road
Rockville MD 20850

JUN 16 1997

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

Re: K970150
Trade Name: Mycoplasma IgG ELISA Test System
Regulatory Class: I
Product Code: LJZ
Dated: January 13, 1997
Received: January 15, 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 Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP 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 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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03/18/96 12:47 301 594 5941
CDRH ODE
00

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510(k) Number (if known): K970150

Device Name: Mycoplasma IgG ELISA Test System

Indications For Use:

Mycoplasma IgG ELISA test system; K970150

M. pneumoniae is the simplest self-replicating microorganism known. It is primarily a respiratory tract pathogen, and is one of the most common causes of pneumonia and upper-respiratory tract infections. Symptomatic infections attributable to this organism most commonly occur in children and young adults; however, the elderly may also be at risk.

Clinical signs of the onset of illness are gradual and characterized by headache, malaise, and fever; cough is prominent, and sore throat is frequent. For patients presenting such clinical symptoms, this test system may aid in the determination of the patient'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 IgG-class antibody to M. pneumoniae in human serum. The test system is for in vitro diagnostic use.

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number K970150

Prescription Use ☑
(Per 21 CFR 801.109)

OR

Over-The-Counter Use ☐

(Optional Format 1-2-96)