OXOID PYLORI TEST KIT, MODEL DR0130M

K012588 · Oxoid , Ltd. · LYR · Dec 10, 2001 · Microbiology

Device Facts

• Record ID: K012588
• Device Name: OXOID PYLORI TEST KIT, MODEL DR0130M
• Applicant: Oxoid , Ltd.
• Product Code: LYR · Microbiology
• Decision Date: Dec 10, 2001
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.3110
• Device Class: Class 1

Indications 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.

Device Story

Oxoid Pylori Test Kit is a rapid latex agglutination assay for qualitative detection of H. pylori antibodies in human serum. Device used in clinical laboratory settings by trained personnel. Input is patient serum sample; principle of operation involves latex particles coated with H. pylori antigens; presence of specific antibodies causes visible agglutination. Output is qualitative (positive/negative) result interpreted visually by clinician. Aids in diagnosis of H. pylori infection in symptomatic patients. Benefits include rapid diagnostic information to guide clinical management of gastro-intestinal disorders.

Clinical Evidence

No clinical data provided in the document; submission relies on bench-level performance characteristics typical of latex agglutination diagnostic kits.

Technological Characteristics

Rapid latex agglutination test; utilizes latex particles coated with H. pylori antigens. In vitro diagnostic device. No software or electronic components.

Indications for Use

Indicated for qualitative detection of Helicobacter pylori total antibodies in serum for patients 18 years and older presenting with symptoms of gastro-intestinal disorders.

Regulatory Classification

Identification

Campylobacter fetus serological reagents are devices that consist of antisera conjugated with a fluorescent dye used to identify Campylobacter 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.

Submission Summary (Full Text)

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

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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 [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or [phone] 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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## 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