(402 days)
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No
The provided text describes a standard in vitro diagnostic assay (Western Blot) for detecting antibodies. There is no mention of AI, ML, image processing, or any computational analysis that would suggest the use of such technologies.
No
The device is an in vitro diagnostic assay used for the detection of antibodies to Borrelia burgdorferi in human serum, which is for diagnostic purposes, not for treating a disease or condition.
Yes
The device is described as an "in vitro qualitative assay for the detection of antibodies to Borrelia burgdorferi in human serum" and states that "Positive results from this Western Blot assay are supportive evidence of infection with B.burgdorferi, the causative agent of Lyme disease." This directly indicates its use in diagnosing a medical condition.
No
The device is described as an "in vitro qualitative assay" and a "kit," which strongly indicates it is a physical diagnostic test kit containing reagents and other materials, not a software-only device.
Yes, this device is an IVD (In Vitro Diagnostic).
The "Intended Use / Indications for Use" section explicitly states:
"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."
The term "in vitro" means "in glass" or "in the lab," referring to tests performed outside of a living organism. This is the defining characteristic of an in vitro diagnostic device.
N/A
Intended Use / 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. II 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.
l he Cambridge Diagnostics Ireland Ltd. Human Lyme Borrelia burgdorfen IgM Western Blol kil can be used during the acute phase (0-4 weeks of symptoms onset) of B. burgdorfen infection. After this early period, infected patients are usually found to be Western Blot positive for IgG. A positive IgM test alone is not rocommended for use in determining aclive disease in persons with illness of longer than one month.
Product codes
LSR
Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s)
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Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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).
0
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 stylized eagle with three tail feathers, representing the three levels of government: federal, state, and local. The eagle is surrounded by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.
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 (OS) 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 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
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. II 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.
l he Cambridge Diagnostics Ireland Ltd. Human Lyme Borrelia burgdorfen IgM Western Blol kil can be used during the acute phase (0-4 weeks of symptoms onset) of B. burgdorfen infection. After this early period, infected patients are usually found to be Western Blot positive for IgG. A positive IgM test alone is not rocommended for use in determining aclive 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)
| (Division Sign-Off) | |
|---|---|
| Division of Clinical Laboratory Devices | |
| 510(k) Number | K970768 |
| Prescription Use | |
|---|---|
| (Per 21 CFR 801.109) |
OR
Over-The-Counter Use
(Optional Format 1-2-96)