(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.
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Food and Druq Administration 2098 Gaither Road Rockville MD 20850
JAN 2 9 2003
Mr. Ricardo R. Martinez Director of Regulatory Affairs SA Scientific, Inc. 4919 Golden Quail San Antonio, TX 78240
Re: K022845
Trade/Device Name: SASTM RSV Test Regulation Number: 21 CFR 866.3480 Regulation Name: Respiratory Syncytial Virus Serological Reagents. Regulatory Class: Class I Product Code: GQG Dated: January 13, 2003 Received: January 19, 2003
Dear Mr. Martinez:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug. and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other reguirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); and good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820).
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This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 594-3084. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.
Sincerely vours.
Steven Sutman
Steven I. Gutman, M.D., M.B.A. Director Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
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INDICATIONS FOR USE
Applicant: SA Scientific, Inc. 4919 Golden Quail San Antonio, TX. 78240 Ph: (210) 699-8800 Fax: (210) 699-6545
Establishment Reg. No.: 1645225
501(k) Number: K023845
Device Name:
SAS™ RSV Test
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.
(Please do not write below this line)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Per 21 CFR 801.109
(21 CFR 801.109) Freddie Lu. Poole
(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number K022845
Prescription Use
✓
or
Over-the-Counter
§ 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.