(60 days)
Screening for and/or confirmation of certain febrile diseases by the detection of antibodies in serum
Not Found
This document (K972391) is a 510(k) clearance letter from the FDA for the VISTA™ Antigen Salmonella H b device. It states that the device is substantially equivalent to legally marketed predicate devices. However, the provided text does not contain the detailed study information, acceptance criteria, or performance data that would be required to answer your specific questions about the device's technical performance.
The letter focuses on the regulatory clearance of the device based on substantial equivalence, rather than a detailed technical report of its performance or the clinical study that led to its validation.
Therefore, I cannot extract the following information from the provided text:
- A table of acceptance criteria and the reported device performance: This information is not present in the regulatory clearance letter. The letter acknowledges the device's substantial equivalence but does not detail performance metrics or acceptance criteria.
- Sample sizes used for the test set and the data provenance: This information is not provided.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: This information is not provided.
- Adjudication method for the test set: This information is not provided.
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and its effect size: This information is not provided.
- If a standalone performance study was done: The document doesn't detail the studies performed, but rather the regulatory outcome based on submitted data.
- The type of ground truth used: This information is not provided.
- The sample size for the training set: This information is not provided.
- How the ground truth for the training set was established: This information is not provided.
The current document is a regulatory approval letter, not a clinical study report. To obtain the information you're asking for, you would typically need to refer to the 510(k) submission summary or the actual studies cited within the submission, which are not part of this letter.
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Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Robin C. Hart, Ph.D. Quality Assurance/Regulatory Affairs Manager · Lee Laboratories 1475 Athens Highway Grayson, GA 30221
AUG 25 1997
Re: K972391 Trade Name: VISTA™ Antigen Salmonella H b Regulatory Class: II Product Code: GNC Dated: June 24, 1997 Received: June 26, 1997
Dear Dr. Hart:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (OS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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This letter will allow you to begin marketing your device as described in your 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 advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in-vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4588. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Steven Sutman
Steven I. Gutman, M.D., M.B.A. Director Division of Clinical Laboratory Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name: _________________________________________________________________________________________________________________________________________________________________
Indications For Use:
Screening for and/or confirmation of certain febrile diseases by the detection of antibodies in serum
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| (Division Sign-Off) | |
| Division of Clinical Laboratory Devices |
| 510(k) Number | __________________________ |
|---|---|
| --------------- | ---------------------------- |
| Prescription Use __________(Per 21 CFR 801.109) | OR | Over-The-Counter Use __________ |
|---|---|---|
| ----------------------------------------------------- | ---- | --------------------------------- |
§ 866.3550
Salmonella spp. serological reagents.(a)
Identification. Salmonella spp. serological reagents are devices that consist of antigens and antisera used in serological tests to identifySalmonella spp. from cultured isolates derived from clinical specimens. Additionally, some of these reagents consist of antisera conjugated with a fluorescent dye (immunofluorescent reagents) used to identifySalmonella spp. directly from clinical specimens or cultured isolates derived from clinical specimens. The identification aids in the diagnosis of salmonellosis caused by bacteria belonging to the genusSalmonella and provides epidemiological information on this disease. Salmonellosis is characterized by high grade fever (“enteric fever”), severe diarrhea, and cramps.(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 866.9.