(97 days)
HSV-2 Antigen Control Slides are quality control materials used to confirm the accuracy of staining reagents used in cell culture confirmatory assays for the detection of HSV-2. Each individual slide contains two wells of fixed cells, one HSV-2 infected well and one uninfected well. The two wells of cells on the HSV-2 Antigen Control Slide are stained concomitantly with the cells inoculated with patient sample providing both a positive and negative control for the staining reagents and procedure. Lack of staining of the positive well indicates a failure of one or more components of the staining reagent.
Each individual slide contains two wells of fixed cells, one HSV-2 infected well and one uninfected well.
This document is a 510(k) clearance letter from the FDA for HSV-2 Antigen Control Slides. It does not contain information about the acceptance criteria and study proving device performance in the way requested for an AI/ML device. The device described is a quality control material for laboratory use, not an AI/ML diagnostic tool.
Therefore, I cannot extract the requested information like sample sizes, expert qualifications, or MRMC studies, as these concepts do not apply to this type of device or the content of this specific document.
The document discusses:
- The device being cleared for marketing (HSV-2 Antigen Control Slides).
- Its intended use as quality control for staining reagents in cell culture confirmatory assays for HSV-2.
- The FDA's determination of substantial equivalence to a predicate device.
§ 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).