WELLCOLEX E.COLI O157:H7

K971663 · Murex Biotech , Ltd. · GMZ · Dec 30, 1997 · Microbiology

Device Facts

• Record ID: K971663
• Device Name: WELLCOLEX E.COLI O157:H7
• Applicant: Murex Biotech , Ltd.
• Product Code: GMZ · Microbiology
• Decision Date: Dec 30, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.3255
• Device Class: Class 1

Intended Use

Wellcolex E.coli 0157:H7 is a rapid latex agglutination test for the presumptive identification of Escherichia coli 0157:H7 isolates on laboratory media.

Device Story

Wellcolex E.coli 0157:H7 is a rapid latex agglutination test used in clinical laboratories for the presumptive identification of E. coli 0157:H7 isolates grown on culture media. The device utilizes latex particles coated with specific antibodies that react with the target bacteria. When the test reagent is mixed with a suspected isolate, the presence of E. coli 0157:H7 antigens causes visible agglutination of the latex particles. This provides a rapid visual result for laboratory technicians to assist in the identification of the pathogen. The test is intended for professional use to support clinical decision-making regarding the identification of bacterial isolates.

Technological Characteristics

Latex agglutination assay; utilizes antibody-coated latex particles for antigen detection; visual readout; in vitro diagnostic reagent.

Indications for Use

Indicated for the presumptive identification of Escherichia coli 0157:H7 isolates from laboratory media. For professional use in clinical laboratory settings.

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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Food and Drug Administration 2098 Gaither Road Rockville MD 20850

DEC 3 0 1997

Rebecca Vine Registration Executive Murex Biotech Limited Central Road, Temple Hill Dartford, Kent DA1 5LR England

Re: K971663 Trade Name: Wellcolex E.coli 0157:H7 - ZC61 Regulatory Class: I Product Code: GMZ Dated: October 29, 1997 Received: November 3, 1997

Dear Ms. Vine:

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 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 requirement, 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 [phone].

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" (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 [phone] or at [phone] 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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Image /page/2/Picture/1 description: The image is a black and white seal for the Department of Health & Human Services USA. The seal is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. In the center of the seal is a stylized depiction of a caduceus, a symbol often associated with medicine and healthcare. The caduceus features a staff with two snakes entwined around it, topped with a pair of wings.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

DEC 3 0 1997

Rebecca Vine Registration Executive Murex Biotech Limited Central Road, Temple Hill Dartford, Kent DA1 5LR England

Re: K971663 Trade Name: Wellcolex E.coli 0157:H7 - ZC61 Regulatory Class: I Product Code: GMZ Dated: October 29, 1997 Received: November 3, 1997

Dear Ms. Vine:

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 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 requirement, 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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## Page 2

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 [phone].

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" (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 [phone] or at [phone] 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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Page 1 of 1

510(K) Number - K971663

Device Name:- Wellcolex E.coli 0157:H7 - ZC61

Indications for Use:

Wellcolex E.coli 0157:H7 is a rapid latex agglutination test for the presumptive identification of Escherichia coli 0157:H7 isolates on laboratory media.

Concurrence of CDRH, Office of Device Evaluation (ODE)

or

V Prescription Use (Per 21 CFR 801.109)

Over-The-Counter Use (Optional Format 1-2-96)

John Ticehurst MD, Interim Chief

(Division Sign-Off) Microbiology Br 12/17/97
Division of Clinical Laboratory Devices

510(k) Number ***_*****_**