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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.

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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.

Ask a specific question about this device