(77 days)
The Zeus Scientific, Inc., Helicobacter pylori IgG ELISA Test System is an enzyme-linked immunosorbent assay for the qualitative detection of IgG antibodies to Helicobacter pylori in symptomatic adults 18 years or older. The test system is for in vitro diagnostic use.
enzyme-linked immunosorbent assay for the qualitative detection of IgG antibodies to Helicobacter pylori
I am sorry, but the provided text does not contain the detailed information necessary to answer your request about the acceptance criteria, study design, and results. The document is an FDA 510(k) clearance letter for a "Helicobacter pylori IgG ELISA Test System," which indicates that the device has been found substantially equivalent to a predicate device.
However, it does not include:
- A table of acceptance criteria and reported device performance.
- Details about sample sizes for test or training sets.
- Information on data provenance.
- The number or qualifications of experts used for ground truth.
- The adjudication method.
- Results from a multi-reader multi-case (MRMC) comparative effectiveness study.
- Results from a standalone performance study.
- The type of ground truth used.
- How ground truth was established for the training set.
This document is primarily concerned with the regulatory clearance of the device rather than the specific details of its validation study and performance metrics.
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Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
AUG 12 1999
Mr. Mark J. Kopnitsky Vice President Research & Development Zeus Scientific, Inc. P.O. Box 38 Raritan, New Jersey 08869
K991820 Re:
Trade Name: Helicobacter pylori IgG ELISA · Test System Regulatory Class: I Product Code: LYR Dated: May 19, 1999 Received: May 27, 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 OS 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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Page 1 of 1
510(k) Number (if known): __
Device Name: Helicobacter pylori IgG ELISA Test System
Indications for Use:
Helicobacter pylori IgG ELISA Test System; 3Z512021G
.. .
The Zeus Scientific, Inc., Helicobacter pylori IgG ELISA Test System is an enzyme-linked immunosorbent assay for the qualitative detection of IgG antibodies to Helicobacter pylori in symptomatic adults 18 years or older. The test system is for in vitro diagnostic use.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Woody Dubois
Concurrence of CDRH, Office of Device Evaluation (ODE)
inical Laboratory Devices 510(k) Number
Prescription Use (Per 21 CFR 801, 108)
OR
Over-The-Counter Use
(Optional Format 1-2-96)
§ 866.3110
Campylobacter fetus serological reagents.(a)
Identification. Campylobacter fetus serological reagents are devices that consist of antisera conjugated with a fluorescent dye used to identifyCampylobacter fetus from clinical specimens or cultured isolates derived from clinical specimens. The identification aids in the diagnosis of diseases caused by this bacterium and provides epidemiological information on these diseases.Campylobacter fetus is a frequent cause of abortion in sheep and cattle and is sometimes responsible for endocarditis (inflammation of certain membranes of the heart) and enteritis (inflammation of the intestines) in humans.(b)
Classification. Class I (general controls).