(70 days)
This test system is designed for the manual or automated, qualitative detection of IgM antibodies to Herpes Simplex Virus (HSV) type 1 and type 2 in human serum. The test system is designed to detect IgM antibody to HSV-1 and/or HSV-2. but can not distinquish between the two IgM antibodies. The test system is intended to evaluate serologic evidence of primary or reactivated infection with HSV-1 and/or HSV-2.
Not Found
The provided text is a 510(k) clearance letter from the FDA for a device called "The APTUS (Automated) Application of the HSV 1/2 IgM ELISA". It outlines the regulatory approval process but does not contain any information regarding acceptance criteria or a study proving the device meets those criteria.
Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them, as this information is not present in the provided document.
§ 866.3305 Herpes simplex virus serological assays.
(a)
Identification. Herpes simplex virus serological assays are devices that consist of antigens and antisera used in various serological tests to identify antibodies to herpes simplex virus in serum. Additionally, some of the assays consist of herpes simplex virus antisera conjugated with a fluorescent dye (immunofluorescent assays) used to identify herpes simplex virus directly from clinical specimens or tissue culture isolates derived from clinical specimens. The identification aids in the diagnosis of diseases caused by herpes simplex viruses and provides epidemiological information on these diseases. Herpes simplex viral infections range from common and mild lesions of the skin and mucous membranes to a severe form of encephalitis (inflammation of the brain). Neonatal herpes virus infections range from a mild infection to a severe generalized disease with a fatal outcome.(b)
Classification. Class II (special controls). The device is classified as class II (special controls). The special control for the device is FDA's revised guidance document entitled “Class II Special Controls Guidance Document: Herpes Simplex Virus Types 1 and 2 Serological Assays.” For availability of the guidance revised document, see § 866.1(e).