(125 days)
This test system is designed for the manual or automated, qualitative, for the presumptive (first-step) detection of IgG and/or IgM antibody to Borrelia burgdorferi in human serum from patients with history, signs, or symptoms suggestive of infection with B. burgdorferi. The test system is intended to by used as an aid in the diagnosis of Lyme disease, and is for in vitro diagnostic use.
Not Found
The provided text is a Food and Drug Administration (FDA) 510(k) clearance letter for the "Aptus (Automated) Application for the B. burgdorferi Antibody ELISA Test System." This document grants market clearance based on substantial equivalence to a predicate device.
The letter itself does not contain the acceptance criteria or the study details that prove the device meets these criteria. Such information would typically be found in the 510(k) submission summary or a separate technical document, which are not provided here.
Therefore, I cannot extract the requested information from the given text. The document only confirms that the device has been reviewed and found substantially equivalent for its stated indications for use.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread, symbolizing the department's mission to protect and promote the health and well-being of the nation.
Public Health Service
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
MAR 2 3 1999
Mark J. Kopnitsky Vice President of Research & Development Zeus Scientific, Inc. 200 Evans Way Branchburg, NJ 08876
Re: K984138
Trade Name: Aptus (Automated) Application for the B. burgdorferi Antibody ELISA Test System
Regulatory Class: II Product Code: LSR Dated: February 3, 1999 Received: February 5, 1999
Dear Mr. Kopnitsky:
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 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). 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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Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA-88), this device may require a CLIA complexity categorization. To determine if it does, you should contact the Centers for Disease Control and Prevention (CDC) at (770)488-7655.
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 at (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html"
Sincerely yours,
Steven Butman
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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ડપર વાડપુ 510(k) Number (if known):
Page
Aptus (Automated) Application for the B. Device Name: burgdorferi Antibody ELISA Test System
Indications for Use:
This test system is designed for the manual or automated, qualitative, for the presumptive (first-step) detection of IgG and/or IgM antibody to Borrelia burgdorferi in human serum from patients with history, signs, or symptoms suggestive of infection with B. burgdorferi. The test system is intended to by used as an aid in the diagnosis of Lyme disease, and is for in vitro diagnostic use.
Revised: 12-2-98
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
OR
Over-The-Counter Use
(Per 21 CFR 801,109)
(Optional Format 1-
2-96)
Woody Dulan
linical Laboratory Devi 510(k) Number
§ 866.3830
Treponema pallidum treponemal test reagents.(a)
Identification. Treponema pallidum treponemal test reagents are devices that consist of the antigens, antisera and all control reagents (standardized reagents with which test results are compared) which are derived from treponemal sources and that are used in the fluorescent treponemal antibody absorption test (FTA-ABS), theTreponema pallidum immobilization test (T.P.I.), and other treponemal tests used to identify antibodies toTreponema pallidum directly from infecting treponemal organisms in serum. The identification aids in the diagnosis of syphilis caused by bacteria belonging to the genusTreponema and provides epidemiological information on syphilis.(b)
Classification. Class II (performance standards).