(122 days)
Oxoid Pylori Test Kit is a rapid latex agglutination test for the qualitative detection of Helicobacter onlori total antibodies in serum as an aid in the diagnosis of infections by H. pylori. The product is intended for use to test patients 18 years and older, with symptoms of gastro-intestinal disorders.
rapid latex agglutination test
I am sorry, but based on the provided text, there is no information about acceptance criteria, device performance, sample sizes, expert ground truth, adjudication methods, MRMC studies, or standalone algorithm performance. The document is a 510(k) clearance letter from the FDA for the Oxoid Pylori Test Kit, focusing on its substantial equivalence to a predicate device and its intended use. It does not contain the detailed study information you are requesting.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Image /page/0/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus, which is a symbol of medicine, with three lines representing the serpent entwined around a staff. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the caduceus.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Mr. Andy Hollingsworth Regulatory Affairs Manager Oxoid Limited Wade Road Basingstoke Hants RG24 8PW England
DEC 1 0 2001
Re: K012588
Trade/Device Name: Oxoid Pylori Test Kit Regulation Number: 21 CFR 866.3110 Regulation Name: Campylobacter Pylori Regulatory Class: Class I Product Code: LYR Dated: November 15, 2001 Received: November 16, 2001
Dear Mr. Hollingsworth:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) that do not require approval of a premarket approval application (PMA). 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 (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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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 1 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" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsma/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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Image /page/2/Picture/0 description: The image shows the word "OXOID" in white letters against a black oval background. The letters are slightly distorted, giving them a textured appearance. The oval shape provides a clear border around the word, making it stand out.
510(K) Submission for Oxoid Pylori Test Kit
510(K) Number : Unknown
Oxoid Pylori Test Kit Device Name :
Indication for Use :
Oxoid Pylori Test Kit is a rapid latex agglutination test for the qualitative detection of Helicobacter onlori total antibodies in serum as an aid in the diagnosis of infections by H. pylori. The product is intended for use to test patients 18 years and older, with symptoms of gastro-intestinal disorders.
Fuddie tu. Pode
(Division Sign-Off) Division of Clinical Laboratory Devices
K012588 510(k) Number
Prescription Use
Over-the-Counter-Use. ... ................... OR
§ 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).