(155 days)
SAS™ RSV antigen test kit is a visual and rapid assay for the qualitative detection of Respiratory Syncytial Virus (RSV) antigen directly from nasopharyngeal specimens. The test is for professional use.
Not Found
I am sorry, but based on the provided text, there is no information about acceptance criteria or a study that proves the device meets specific criteria. The document is an FDA 510(k) clearance letter for the SASTM RSV Test, indicating that the device has been found substantially equivalent to legally marketed predicate devices.
The letter mentions:
- Trade/Device Name: SASTM RSV Test
- Regulation Number: 21 CFR 866.3480
- Regulation Name: Respiratory Syncytial Virus Serological Reagents.
- Regulatory Class: Class I
- Indications for Use: "SAS™ RSV antigen test kit is a visual and rapid assay for the qualitative detection of Respiratory Syncytial Virus (RSV) antigen directly from nasopharyngeal specimens. The test is for professional use."
However, it does not include:
- A table of acceptance criteria and reported device performance.
- Details about sample size, data provenance, number of experts, adjudication methods for a test set.
- Information on MRMC comparative effectiveness studies or standalone algorithm performance.
- Details about the type of ground truth used or the sample size and ground truth establishment for a training set.
The FDA 510(k) clearance process focuses on substantial equivalence to a predicate device, and while it requires demonstration of safety and effectiveness, the provided document does not contain the specific study details you are asking for. Such information would typically be found in the 510(k) submission itself or related study reports, not in the clearance letter.
§ 866.3480 Respiratory syncytial virus serological reagents.
(a)
Identification. Respiratory syncytial virus serological reagents are devices that consist of antigens and antisera used in serological tests to identify antibodies to respiratory syncytial virus in serum. Additionally, some of these reagents consist of respiratory syncytial virus antisera conjugated with a fluorescent dye (immunofluorescent reagents) and used to identify respiratory syncytial viruses from clinical specimens or from tissue culture isolates derived from clinical specimens. The identification aids in the diagnosis of respiratory syncytial virus infections and provides epidemiological information on diseases caused by these viruses. Respiratory syncytial viruses cause a number of respiratory tract infections, including the common cold, pharyngitis, and infantile bronchopneumonia.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 866.9.