(189 days)
This test system is designed for the manual or automated, qualitative detection of IgG antibodies to HSV-1 in human serum. The test system is intended to be used to evaluate serologic evidence of primary or reactivated infection with HSV. Due to cross reactivity of shared antigens, the HSV-2 IgG ELISA test should be performed in conjunction with this test system to fully evaluate the patient serum. The test is for in vitro diagnostic use.
Not Found
The provided text is an FDA 510(k) clearance letter for the "Aptus (automated) Application for the HSV-1 IgG ELISA Test". It grants permission to market the device but does not contain the acceptance criteria or a detailed description of the study that proves the device meets those criteria.
The document primarily focuses on:
- Confirming the substantial equivalence of the device to a predicate device.
- Outlining regulatory classifications and general controls.
- Providing contact information for various FDA departments.
- Stating the intended use of the device.
Therefore, I cannot extract the requested information (acceptance criteria, study details, sample sizes, expert qualifications, etc.) directly from the provided text. To answer your questions, the actual 510(k) submission document or a summary of safety and effectiveness would be required, which typically includes performance data and the criteria used for evaluation.
§ 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).