(148 days)
The Zeus Scientific, Inc., B. burgdorferi Western Blot Test System is designed for the qualitative detection of IgG class antibodies to specific proteins associated with B. burgdorferi, the causative agent of Lyme Disease. The 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 of Borrelia burgdorferi.
Borrelia burgdorferi IgG Western Blot Test System
This document is a 510(k) clearance letter from the FDA for a diagnostic device, not a study report or clinical trial summary. Therefore, most of the requested information regarding acceptance criteria, device performance, study details, and ground truth establishment is not present in the provided text.
However, based on the information that is available:
1. A table of acceptance criteria and the reported device performance:
This information is not provided in the FDA clearance letter. The letter confirms substantial equivalence but does not detail the specific performance metrics or acceptance criteria used to achieve that equivalence.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
This information is not provided in the FDA clearance letter.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
This information is not provided in the FDA clearance letter.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
This information is not provided in the FDA clearance letter.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
This is an in vitro diagnostic device (a test system), not an AI-assisted imaging or clinical decision support tool. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance is not applicable to this type of device and is not mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
This is an in vitro diagnostic test system, which by its nature operates "stand-alone" in producing a result. However, the clearance letter does not discuss the performance of the "algorithm only" as if it were a separate component, but rather the full test system. The device is intended for the "qualitative detection of IgG class antibodies," suggesting a definitive test result without human interpretation being part of the device's output.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
This information is not explicitly stated in the FDA clearance letter. For a diagnostic test like this, the ground truth would typically be established by a reference method (e.g., culture, PCR, or a highly validated serological method) or clinical diagnosis, but the letter does not elaborate on this. The device is intended to provide "supportive evidence of infection of Borrelia burgdorferi," implying it's part of a diagnostic workup, not necessarily a sole definitive diagnosis.
8. The sample size for the training set:
This information is not provided in the FDA clearance letter.
9. How the ground truth for the training set was established:
This information is not provided in the FDA clearance letter.
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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
Re: K991180
Trade Name: Borrelia burgdorferi IgG 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 IgG Western Blot Test System
Indications for Use:
Borrelia burgdorferi IgG Western Blot Test System; 3Z71001G
The Zeus Scientific, Inc., B. burgdorferi Western Blot Test System is designed for the qualitative detection of IgG class antibodies to specific proteins associated with B. burgdorferi, the causative agent of Lyme Disease. The 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 of Borrelia burgdorferi.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Woody Dubois
(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number K99/180
| Prescription Use | X |
|---|---|
| (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).