(71 days)
The OSOM™ Mono Test is intended for the qualitative determination of infectious mononucleosis heterophile antibodies in serum, plasma or whole blood as an aids in the diagnosis of infectious mononucleosis .
OSOM Mono Test uses color immunochromatographic technology with bovine erythrocyte extract coated on the membrane. If the specific IM heterophile antibody is present in the sample, a visible blue test line will appear to indicate a positive result.
The provided text is a 510(k) summary for the OSOM™ Mono Test, an in vitro diagnostic device. It does not contain the detailed study information or acceptance criteria requested in the prompt.
Specifically, the document focuses on:
- Device Identification: Proprietary name, common name, classification.
- Intended Use: Qualitative determination of infectious mononucleosis heterophile antibodies.
- Description: Color immunochromatographic technology.
- Substantial Equivalence Claim: Comparing it to two predicate devices (Meridian's MonoSpot Latex Test and Pacific Biotech's CARDS OS Mono Test) based on similar intended use and technology.
- Regulatory Communication: An FDA letter granting substantial equivalence.
Therefore, I cannot provide a table of acceptance criteria, reported device performance, sample sizes, ground truth information, or details about MRMC or standalone studies because this information is not present in the provided text.
The document implies that the device meets criteria for substantial equivalence to predicates, but it does not specify what those criteria are or present the data from a study to demonstrate performance against such criteria. The letter from the FDA confirms that the device is substantially equivalent to legally marketed predicate devices, which means its performance is considered comparable enough, but the specific data supporting that comparison is not in this extract.
§ 866.5640 Infectious mononucleosis immunological test system.
(a)
Identification. An infectious mononucleosis immunological test system is a device that consists of the reagents used to measure by immunochemical techniques heterophile antibodies frequently associated with infectious mononucleosis in serum, plasma, and other body fluids. Measurements of these antibodies aid in the diagnosis of infectious mononucleosis.(b)
Classification. Class II (performance standards).