DRYSPOT E.COLI 0157 KIT

K993401 · Oxoid , Ltd. · GNA · Feb 28, 2000 · Microbiology

Device Facts

• Record ID: K993401
• Device Name: DRYSPOT E.COLI 0157 KIT
• Applicant: Oxoid , Ltd.
• Product Code: GNA · Microbiology
• Decision Date: Feb 28, 2000
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.3255
• Device Class: Class 1

Intended Use

The Oxoid Dryspot E.coli 0157 test is a latex agglutination test for the identification of E.coli serogroup 0157 in colonies isolated from Sorbitol MacConkey (SMAC) Agar or SMAC Agar with Cefixime Tellurite Supplement. The test is not indicated for direct testing of faccal specimens.

Device Story

Dryspot E. coli 0157 Kit is a latex agglutination test used in clinical microbiology laboratories. It identifies E. coli serogroup 0157 from isolated bacterial colonies grown on specific culture media (SMAC or SMAC with Cefixime Tellurite). The test utilizes latex particles sensitized with specific antibodies; when mixed with a suspension of the target bacteria, visible agglutination occurs if E. coli 0157 is present. The procedure is performed by laboratory technicians. Results provide rapid confirmation of the serogroup, aiding in the identification of potential pathogens. It is not intended for direct fecal sample analysis.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Latex agglutination assay. Uses latex particles sensitized with specific antibodies for the detection of E. coli 0157 antigens. In vitro diagnostic test format.

Indications for Use

Indicated for the identification of E. coli serogroup 0157 in bacterial colonies isolated from Sorbitol MacConkey (SMAC) Agar or SMAC Agar with Cefixime Tellurite Supplement. Contraindicated for direct testing of fecal specimens.

Regulatory Classification

Identification

Escherichia coli serological reagents are devices that consist of antigens and antisera used in serological tests to identify Escherichia coli from cultured isolates derived from clinical specimens. Additionally, some of these reagents consist of Escherichia coli antisera conjugated with a fluorescent dye used to identify Escherichia coli directly from clinical specimens or cultured isolates derived from clinical specimens. The identification aids in the diagnosis of diseases caused by this bacterium belonging to the genus Escherichia, and provides epidemiological information on diseases caused by this microorganism. Although Escherichia coli constitutes the greater part of the microorganisms found in the intestinal tract in humans and is usually nonpathogenic, those strains which are pathogenic may cause urinary tract infections or epidemic diarrheal disease, especially in children.

Submission Summary (Full Text)

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FEB 2 8 2000

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

Re: K993401 Trade Name: Dryspot E. Coli 0157 Kit Regulatory Class: I Product Code: GNA Dated: December 10, 1999 Received: December 16, 1999

Dear Mr. Hollingsworth:

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 (OS) 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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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 [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 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 Autman

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 Dryspot E.coli 0157 kit

510(K) Number: K993401

Dryspot E.coli 0157 Kit Device Name:

## Indications for Use:

The Oxoid Dryspot E.coli 0157 test is a latex agglutination test for the identification of E.coli serogroup 0157 in colonies isolated from Sorbitol MacConkey (SMAC) Agar or SMAC Agar with Cefixime Tellurite Supplement. The test is not indicated for direct testing of faccal specimens.

Wordy Dubois

Division of C 510(k) Number .

Prescription Use ....

OR

Over-the-Counter-Use .........................................................................................................................................................