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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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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.

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Ask a specific question about this device

Ask a specific question about this device

Ask a specific question about this device