(53 days)
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 manual or automated, qualitative detection of IgM-class antibody to M. pneumoniae in adult human serum. The test system is for in vitro diagnostic use.
Aptus (automated) Application for the Mycoplasma IgM ELISA Test System
This is a letter from the FDA to Zeus Scientific, Inc. regarding the 510(k) premarket notification for their Aptus (automated) Application of the Mycoplasma IgM ELISA Test System. This document DOES NOT contain the acceptance criteria or details of a study proving the device meets acceptance criteria. It primarily addresses the substantial equivalence determination and regulatory requirements for marketing the device.
Therefore, I cannot provide the requested information based on the provided text.
§ 866.3375
Mycoplasma spp. serological reagents.(a)
Identification. Mycoplasma spp. serological reagents are devices that consist of antigens and antisera used in serological tests to identify antibodies toMycoplasma spp. in serum. Additionally, some of these reagents consist ofMycoplasma spp. antisera conjugated with a fluorescent dye (immunofluorescent reagents) used to identifyMycoplasma spp. directly from clinical specimens. The identification aids in the diagnosis of disease caused by bacteria belonging to the genusMycoplasma 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 withMycoplasma pneumoniae range from inapparent infection to mild or severe upper respiratory disease, ear infection, and bronchial pneumonia.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 866.9.