(149 days)
The Zeus Scientific, Inc. Helicobacter pylori IgG ELISA test System is intended for the qualitative detection of IgG antibody in symptomatic adult serum. It may or may not be indicated as an aid in the determination of serological status.
Not Found
I am sorry, but based on the provided text, I cannot extract the specific acceptance criteria, study details, or performance metrics within the document. The text is a formal letter from the FDA regarding a 510(k) clearance for the "Helicobacter pylori IgG ELISA Test System," confirming its substantial equivalence to previously marketed devices.
This type of letter focuses on the regulatory approval and does not typically include the detailed technical performance data of the device, the study design, or the specific criteria met for that approval. These details would usually be found within the 510(k) submission document itself, which is not provided here.
Therefore, I cannot provide the requested table or answer the specific questions about sample size, expert qualifications, adjudication methods, or training set details.
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July 3 0 1998
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Mark J. Kopnitsky Vice President, Research & Development Zeus Scientific, Inc. P.O. Box 38 Raritan, NJ 08869
Re: K980821
Trade Name: Helicobacter pylori IgG ELISA Test System Regulatory Class: I Product Code: LYR Dated: July 6, 1998 Received: July 7, 1998
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 vour 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
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510(k) Number (if known): K980821
Helicobacter pylori IgG ELISA Test System Device Name:
Indications for Use:
The Zeus Scientific, Inc. Helicobacter pylori IgG ELISA test System is intended for the qualitative detection of IgG antibody in symptomatic adult serum. It may or may not be indicated as an aid in the determination of serological status.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Woody Declaies
(Division Sign Off)
Division of Clinical Laboratory Devices
Division of Clinical Laboratory Devices
510(k) Number K980821
Prescription Use (Per 21 CFR 801, 109)
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).