(148 days)
The Zeus Scientific, Inc., B. burgdorferi Western Blot Test System is designed for the qualitative detection of IgM class antibodies to specific proteins associated with B. burgdorferi, the causative agent of Lyme Disease. This test system is intended to be used for testing human serum samples which have been found to be positive or equivocal by an EIA or IFA screening procedure. The test is therefore intended to provide supportive evidence of infection with Borrelia burgdorferi.
Borrelia burgdorferi IgM Western Blot Test System
I am sorry, but the provided text does not contain the information required to describe the acceptance criteria and the study that proves the device meets those criteria in the requested format. The document is an FDA 510(k) clearance letter confirming that the Borrelia burgdorferi IgM Western Blot Test System is substantially equivalent to legally marketed predicate devices. It does not include details on specific acceptance criteria for performance, the study design, sample sizes, expert qualifications, or ground truth establishment.
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SEP 3 1999
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Mr. Mark J. Kopnitsky Vice President of Research & Development Zeus Scientific, Inc. 200 Evans Way Branchburg, New Jersey 08876
K991185 Re:
Trade Name: Borrelia burgdorferi IgM Western Blot Test System Regulatory Class: II Product Code: LSR Dated: June 25, 1999 Received: June 29, 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 (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 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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510(k) Number (if known): _
Device Name: Borrelia burgdorferi IgM Western Blot Test System
Indications for Use:
Borrelia burgdorferi IgM Western Blot Test System; 3Z71001M
The Zeus Scientific, Inc., B. burgdorferi Western Blot Test System is designed for the qualitative detection of IgM class antibodies to specific proteins associated with B. burgdorferi, the causative agent of Lyme Disease. This test system is intended to be used for testing human serum samples which have been found to be positive or equivocal by an EIA or IFA screening procedure. The test is therefore intended to provide supportive evidence of infection with Borrelia burgdorferi.
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Concurrence of CDRH, Office of Device Evaluation (ODE)
Woody Dubois
(Division Sign Off)
Division of Clinical Laboratory Devices
510(k) Number K991185
| Prescription Use | |
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| (Per 21 CFR 801,109) |
OR
Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________
(Optional Format 1-2-96)
§ 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).