LIMITED HUMAN LYME IGG WESTERN BLOT KIT (CAMBRIDGE DIAGNOSTICS IRELAND) by CAMBRIDGE DIAGNOSTICS IRELAND, LTD.

The Cambridge Diagnostics Ireland Ltd. Human Lyme Borrelia burgdorferi Western Blot IgG kit is an in vitro qualitative assay for the detection of antibodies to Borrelia burgdorferi in human serum. It is intended for use in testing human serum samples which have been found positive or equivocal using an EIA or IFA test procedure for Borrelia burgdorferi antibodies. Positive results from this Western Blot assay are supportive evidence of infection with Borrelia burgdorferi, the causative agent of Lyme Disease.

The Cambridge Diagnostics Ireland Ltd. Human Lyme Borrelia burgdorferi Western Blot IgG kil can be used at any time following onset of symptoms provided the EIA or IFA is positive or equivocal. It should be used for follow up when: 1) Only IgM antibodies were originally detected, 2) IgG antibodies were detected but were not considered significant by Western blot, or 3) previously tested seronegative individuals are shown to develop antibodies by EIA or IFA tests.

Device Description

Not Found

AI/ML Overview

The provided text is a 510(k) premarket notification approval letter for the "CDIL Human Lyme Borrelia burgdorferi Western Blot IgG kit". While it defines the "Indications For Use" for the device, it does not contain any information about acceptance criteria or a study proving the device meets those criteria, nor does it provide details about sample sizes, expert qualifications, ground truth establishment, or comparative effectiveness studies.

The letter is a regulatory document confirming that the FDA has reviewed the submission and found the device substantially equivalent to legally marketed predicate devices, thereby permitting its marketing. It does not include the detailed performance data or study design that would be found in the actual 510(k) submission or supporting technical documentation.

Summary

{0}------------------------------------------------

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with flowing lines connecting them.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

APR - 9 1998

Sile MacMahon Product Manager Cambridge Diagnostics Ireland, Ltd. Mervue Industrial Estate Galway Ireland

Re: K970761

Trade Name: Human Lyme Borrelia burgdorferi IgG Western Blot Kit Regulatory Class: II Product Code: LSR Dated: February 2, 1998 Received: February 3, 1998

Dear Ms. MacMahon:

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.

{1}------------------------------------------------

Page 2

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 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

{2}------------------------------------------------

510(x) Number (:f Known): K970761

Device Name; CDIL Human Lyme Borrelia burgdorferi Western Blot IgG kit

Indications For Use:

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF I NEEDED)

	Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of	Clinical Laboratory Devices
510(k) Number	K970761

Prescription Use
(Per 21 CFR 801.109)

Over-The-Counter Use
(Optional Format 1-2-96)

Regulation Number and Section

§ 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).