HUMAN LYME IGM WESTERN BLOT KIT

K970768 · Cambridge Diagnostics Ireland, Ltd. · LSR · Apr 9, 1998 · Microbiology

Device Facts

• Record ID: K970768
• Device Name: HUMAN LYME IGM WESTERN BLOT KIT
• Applicant: Cambridge Diagnostics Ireland, Ltd.
• Product Code: LSR · Microbiology
• Decision Date: Apr 9, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.3830
• Device Class: Class 2

Intended Use

The Cambridge Diagnostics Ireland Ltd. Human Lyme Borrelia burgdorferi Western Blot IgM 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 B. burgdorferi antibodies. Positive results from this Western Blot assay are supportive evidence of infection with B. burgdorferi, the causative agent of Lyme disease. The Cambridge Diagnostics Ireland Ltd. Human Lyme Borrelia burgdorferi IgM Western Blot kit can be used during the acute phase (0-4 weeks of symptoms onset) of B. burgdorferi infection. After this early period, infected patients are usually found to be Western Blot positive for IgG. A positive IgM test alone is not recommended for use in determining active disease in persons with illness of longer than one month.

Device Story

In vitro diagnostic assay; detects IgM antibodies to Borrelia burgdorferi in human serum. Used as follow-up test for samples testing positive/equivocal via EIA or IFA. Operates via Western Blot technique; identifies specific antibody presence. Used in clinical laboratory settings by trained laboratory personnel. Results provide supportive evidence of Lyme disease infection during acute phase (0-4 weeks). Assists clinicians in confirming diagnosis when combined with clinical presentation and screening test results. Benefits patient by providing specific serological confirmation of early-stage Lyme disease.

Clinical Evidence

No clinical data provided in the document. Substantial equivalence is based on the device's intended use and technological characteristics as an in vitro diagnostic assay.

Technological Characteristics

In vitro qualitative Western Blot assay. Detects IgM antibodies to Borrelia burgdorferi. Manual or semi-automated laboratory test format. No electronic components, software, or connectivity features.

Indications for Use

Indicated for qualitative detection of IgM antibodies to Borrelia burgdorferi in human serum. Intended for patients with positive/equivocal EIA or IFA screening results. Use limited to acute phase (0-4 weeks post-symptom onset). Not recommended for patients with symptoms >1 month.

Regulatory Classification

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), the Treponema pallidum immobilization test (T.P.I.), and other treponemal tests used to identify antibodies to Treponema pallidum directly from infecting treponemal organisms in serum. The identification aids in the diagnosis of syphilis caused by bacteria belonging to the genus Treponema and provides epidemiological information on syphilis.

Submission Summary (Full Text)

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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
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: K970768
Trade Name: Human Lyme Borrelia burgdorferi IgM 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.

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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 [phone].

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 at [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html"

Sincerely yours,

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): K970768

Device Name: CDIL Human Lyme Borrelia burgdorferi IgM Western Blot kit

Indications For Use:

The Cambridge Diagnostics Ireland Ltd. Human Lyme Borrelia burgdorferi Western Blot IgM 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 B. burgdorferi antibodies. Positive results from this Western Blot assay are supportive evidence of infection with B. burgdorferi, the causative agent of Lyme disease.

The Cambridge Diagnostics Ireland Ltd. Human Lyme Borrelia burgdorferi IgM Western Blot kit can be used during the acute phase (0-4 weeks of symptoms onset) of B. burgdorferi infection. After this early period, infected patients are usually found to be Western Blot positive for IgG. A positive IgM test alone is not recommended for use in determining active disease in persons with illness of longer than one month.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)


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