(60 days)
Screening for and/or confirmation of certain febrile diseases by the detection of antibodies in serum
Not Found
This document is an FDA 510(k) clearance letter for the VISTA™ Antigen Salmonella O Group B device, dated August 25, 1997. It declares substantial equivalence to a predicate device for the indication of "Screening for and/or confirmation of certain febrile diseases by the detection of antibodies in serum."
The provided text does not contain the detailed study information required to answer your request regarding acceptance criteria and performance studies. Specifically, it lacks:
- A table of acceptance criteria and reported device performance.
- Information about sample sizes for test sets, data provenance (country, retrospective/prospective).
- Details on the number and qualifications of experts for ground truth establishment.
- Adjudication methods.
- Information about MRMC comparative effectiveness studies or standalone algorithm performance.
- The type of ground truth used (e.g., pathology, outcomes data).
- Sample size and ground truth establishment for the training set.
The FDA letter confirms the device's clearance based on substantial equivalence, but it does not present the underlying study data that would detail how that substantial equivalence was demonstrated or specific performance metrics. To get that information, one would typically need to review the original 510(k) submission summary or detailed study reports, which are not included in this document.
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Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Robin C. Hart, Ph.D. Ouality Assurance/Regulatory Affairs Manager · Lee Laboratories 1475 Athens Highway Grayson, GA 30221
AUG 25 1997
Re: K972386
Trade Name: VISTA™ Antigen Salmonella O Group 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 OS 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 Gutman
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 | ||
|---|---|---|
| Prescription Use ✓ (Per 21 CFR 801.109) | 510(k) Number 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.