VISTA ANTIGEN SALMONELLA O GROUP B

K972386 · Lee Laboratories, Inc. · GNC · Aug 25, 1997 · Microbiology

Device Facts

• Record ID: K972386
• Device Name: VISTA ANTIGEN SALMONELLA O GROUP B
• Applicant: Lee Laboratories, Inc.
• Product Code: GNC · Microbiology
• Decision Date: Aug 25, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.3550
• Device Class: Class 2

Indications for Use

Screening for and/or confirmation of certain febrile diseases by the detection of antibodies in serum

Device Story

VISTA™ Antigen Salmonella O Group B is an in-vitro diagnostic test used for the detection of antibodies in human serum. The device aids in the screening and confirmation of febrile diseases. It is intended for use by clinical laboratory professionals. The test provides qualitative results to assist healthcare providers in diagnosing febrile conditions, facilitating appropriate clinical management and patient care.

Technological Characteristics

In-vitro diagnostic test for antibody detection in serum. Product code GNC; Class II device.

Indications for Use

Indicated for screening and/or confirmation of febrile diseases via detection of antibodies in serum.

Regulatory Classification

Identification

Salmonella spp. serological reagents are devices that consist of antigens and antisera used in serological tests to identify Salmonella 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 identify Salmonella 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 genus Salmonella and provides epidemiological information on this disease. Salmonellosis is characterized by high grade fever (“enteric fever”), severe diarrhea, and cramps.

Special Controls

*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.

Submission Summary (Full Text)

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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 [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or [phone] 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

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Concurrence of CDRH, Office of Device Evaluation (ODE)

| | (Division Sign-Off) Division of Clinical Laboratory Devices | |
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| Prescription Use <span style="text-decoration: overline;">✓</span> (Per 21 CFR 801.109) | 510(k) Number <span style="text-decoration: overline;"></span> OR | Over-The-Counter Use <span style="text-decoration: overline;"></span> |