(256 days)
The Wampole PreVue™ Borrelia burgdorferi Antibody Detection Assay is a single use, unitized immunochromatographic test that uses recombinant B. burgdorferi antigens for the qualitative presumptive (first step) detection of IgG and IgM antibodies to B. burgdorferi in human serum or whole blood. This test should be used only in patients with history, signs and symptoms that are consistent with Lyme disease. The Wampole PreVue™ Borrelia burgdorferi Antibody Detection Assay is intended for use in clinical and physicians' office laboratories.
The Wampole PreVue™ Borrelia burgdorferi Antibody Detection Assay is a Class II in vitro diagnostic device that utilizes standard immunochromatographic chromophore technology to qualitatively detect, in serum or whole blood, the presence of IgG and IgM antibodies to recombinant Borrelia burgdorferi antigens, as an aid in the diagnosis of Lyme Disease. It consists of a plastic housing, containing an absorbent material that collects the specimen and, with the addition of buffer, delivers it and adjacent adsorbed reagents, onto a chromatographic strip, onto which recombinant test antigen and control antibodies have been adsorbed within their respective test and control detection zones. As the mixture migrates along the strip, gold-conjugated antibodies specific for human IgG and IgM bind to the antibodies in the specimen. Antibodies specific for Borrelia burgdorferi antigens, if present, will bind to the adsorbed recombinant antigens in the test zone, resulting in a visually detectable colored line due to the presence of goldconjugated antibodies, which are bound to the specimen antibodies. If no antibodies to Borrelia burgdorferi are present, no line will appear in the test zone. A line will always appear in the control zone, indicating a valid result, as goat anti-human IgG antibodies adsorbed in the control zone bind excess IgG in the specimen, which have been bound to the gold-conjugate.
The provided text describes a medical device, the Wampole PreVue™ Borrelia burgdorferi Antibody Detection Assay, but does not contain the detailed acceptance criteria or the study data that proves the device meets specific performance criteria. The document is a 510(k) summary for regulatory submission, focusing on device description, intended use, and substantial equivalence to a predicate device, rather than a full study report with detailed results.
Therefore, I cannot populate the requested table with acceptance criteria and reported device performance, nor can I provide information on sample sizes for test sets, data provenance, number of experts, adjudication methods, MRMC studies, standalone performance, types of ground truth, or details about the training set.
The document mainly focuses on establishing the device's functionality and its substantial equivalence to another device (Wampole Borrelia burgdorferi IgG/IgM ELISA) for regulatory approval.
What information is available in the provided text:
- Device Name: Wampole PreVue™ Borrelia burgdorferi Antibody Detection Assay
- Intended Use: Qualitative presumptive (first step) detection of IgG and IgM antibodies to B. burgdorferi in human serum or whole blood using recombinant B. burgdorferi antigens. It's intended for patients with a history, signs, and symptoms consistent with Lyme disease, and for use in clinical and physicians' office laboratories.
- Predicate Device: Wampole Borrelia burgdorferi IgG/IgM ELISA (510(k) Document Control Number: K965131)
- Technology: Immunochromatographic in vitro diagnostic device, utilizing recombinant Borrelia burgdorferi antigens.
- Claimed Advantages of Recombinant Antigens: Improved specificity and a continued supply of high-quality, uniform antigen.
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Attachment 3
510(k) SUMMARY
Submitted By:
Chembio Diagnostic Systems 3661 Horseblock Road Medford, NY 11763
Contact Person:
Raymond Dattwyler, MD phone: 516/444-2348 (office) pager: 516/282-9611
Date Prepared:
May 26, 1998
Device Name:
Wampole PreVue™ Borrelia burgdorferi Antibody Detection Assay
Classification Name:
Reagent, Borrelia Serological Reagent [21 CFR §866.3830] 83 LSR
Predicate Device:
The Wampole Borrelia burgdorferi IgG/IgM ELISA 510(k) Document Control Number: K965131
Description of Device:
The Wampole PreVue™ Borrelia burgdorferi Antibody Detection Assay is a Class II in diagnostic device that utilizes standard immunochromatographicvitro medical chromophore technology to qualitatively detect, in serum or whole blood, the presence of IgG and IgM antibodies to recombinant Borrelia burgdorferi antigens, as an aid in the diagnosis of Lyme Disease. It consists of a plastic housing, containing an absorbent material that collects the specimen and, with the addition of buffer, delivers it and adjacent adsorbed reagents, onto a chromatographic strip, onto which recombinant test antigen and control antibodies have been adsorbed within their respective test and control detection zones. As the mixture migrates along the strip, gold-conjugated antibodies specific for human IgG and IgM bind to the antibodies in the specimen. Antibodies specific for Borrelia burgdorferi antigens, if present, will bind to the adsorbed recombinant antigens in the test zone, resulting in a visually detectable colored line due to the presence of goldconjugated antibodies, which are bound to the specimen antibodies. If no antibodies to Borrelia burgdorferi are present, no line will appear in the test zone. A line will always appear in the control zone, indicating a valid result, as goat anti-human IgG antibodies adsorbed in the control zone bind excess IgG in the specimen, which have been bound to the gold-conjugate.
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The Wampole PreVue™ Borrelia burgdorferi Antibody Detection Assay is a first step presumptive test for Lyme Disease antibodies, and is substantially equivalent to the Wampole Borrelia burgdorferi IgG/IgM ELISA.
Intended Use of the Device:
The Wampole PreVue™ Borrelia burgdorferi Antibody Detection Assay is a single use, unitized immunochromatographic test that uses recombinant B. burgdorferi antigens for the qualitative presumptive (first step) detection of IgG and IgM antibodies to B. burgdorferi in human serum or whole blood. This test should be used only in patients with history, signs and symptoms that are consistent with Lyme disease. The TBD Lyme test is intended for use in clinical and physicians' office laboratories.
Technological Characteristics:
The Wampole PreVue™ Borrelia burgdorferi Antibody Detection Assay is similar in technology to numerous immunochromatographic serology test devices. Examples include devices that detect IgG against H. pylori, or heterophile antibodies present with Infectious Mononucleosis. However, the test antigens utilized in the Wampole PreVue™ Borrelia burgdorferi Antibody Detection Assay are derived from sufface proteins of Borrelia burgdorferi. A unique difference is that the antigens used in the Wampole PreVue™ Borrelia burgdorferi Antibody Detection Assay are recombinant, while other Lyme Disease serological tests use antigens purified from cultured B. burgdorferi. The use of recombinant antigens allows for improved specificity, as the epitopes that are crossreactive with other, non-specific antibodies, have been deleted. Recombinant technology also allows for a continued supply of high-quality, uniform antigen, which is not dependent upon the repeated passage of any particular strain of B. burgdorferi.
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Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features the department's emblem, which consists of a stylized caduceus-like symbol with three intertwined lines forming a shape resembling an abstract human figure or a bird in flight. The emblem is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in a circular arrangement.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
FEB 1 2 1999
Chembio Diagnostic Systems, Inc. c/o Raymond Dattwyler, M.D. Brook Biotechnologies 25 East Loop Road Stonybrook, NY 11790
Re: K981913
Trade Name: PreVue™ Borrelia burgdorferi Antibody Detection Assay Regulatory Class: II Product Code: LSR Dated: December 3, 1998 Received: December 4, 1998
Dear Dr. Dattwyler:
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 (QS) 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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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 vours.
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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Attachment 2
INDICATIONS FOR USE STATEMENT
K981913 510(k) Number:
Wampole PreVue™ Borrelia burgdorferi Antibody Detection Assay Device Name:
The Wampole PreVue™ Borrelia burgdorferi Antibody Detection Assay is Indications for Use: a single use, unitized immunochromatographic test that uses recombinant B. burgdorferi antigens for the qualitative presumptive (first step) detection of IgG and IgM antibodies to B. burgdorferi in human serum or whole blood. This test should be used only in patients with history, signs and symptoms that are consistent with Lyme disease. The Wampole PreVue™ Borrelia burgdorferi Antibody Detection Assay is intended for use in clinical and physicians' office laboratories.
PRESCRIPTION USE X
i
Woody Dubvia
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).