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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):
  1. Loss of biological activity caused by antigenic deterioration.
  2. 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.

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