(208 days)
HSV-1 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-1. Each individual slide contains two wells of fixed cells, one HSV-1 infected well and one uninfected well. The two wells of cells on the HSV-1 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-1 infected well and one uninfected well.
This document, a 510(k) Pre-Market Notification for the "HSV-1 Antigen Control Slides," primarily provides regulatory information and outlines the intended use and potential problems associated with the device. It does not contain information about a study proving the device meets acceptance criteria.
The document details:
- Device Name: HSV-1 Antigen Control Slides
- Regulatory Class: III
- Product Code: GQN
- Intended Use: To confirm the accuracy of staining reagents used in cell culture confirmatory assays for the detection of HSV-1. Each slide contains one HSV-1 infected well and one uninfected well to act as positive and negative controls for staining reagents and procedure.
- Potential Problems (Type of Problems):
- Loss of biological activity caused by antigenic deterioration.
- Loss (Removal) of the fixed cells in either the infected or uninfected slide wells.
- Impact of Problems: If these problems occur, the slides would indicate staining reagents are not working properly, leading to the test being discarded, but not a false positive or false negative clinical test result.
Therefore, I cannot provide the requested information about acceptance criteria or a study proving the device meets acceptance criteria based on the provided text. The document focuses on the regulatory approval and a certification regarding known safety/effectiveness problems, not on performance data from a specific study.
§ 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).