(118 days)
For patients presenting such clinical symptoms, this test system may aid in 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 IgM-class antibody to M. pneumoniae in adult human serum. The test system is for in vitro diagnostic use.
Zeus Scientific Mycoplasma IgM ELISA Test System.
The provided text is a 510(k) premarket notification approval letter for the "Zeus Scientific Mycoplasma IgM ELISA Test System." This document primarily indicates that the device has been found substantially equivalent to a legally marketed predicate device. It certifies the device's classification and permits its marketing.
However, the document does not contain the detailed study information, acceptance criteria, or performance data that would be required to answer your specific questions about the device's performance, sample sizes, ground truth establishment, or expert involvement. The letter references "indications for use stated in the enclosure," but the enclosure itself is not provided in a format that includes a table of acceptance criteria or performance results.
Therefore, I cannot extract the information requested. The document confirms the device's regulatory approval based on substantial equivalence, but it does not describe the specific studies or their results in the level of detail you are asking for.
§ 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.