DUOPATH VEROTOXINS GLISA TEST

K031367 · Emd Chemicals, Inc. · GNA · Jan 23, 2004 · Microbiology

Device Facts

• Record ID: K031367
• Device Name: DUOPATH VEROTOXINS GLISA TEST
• Applicant: Emd Chemicals, Inc.
• Product Code: GNA · Microbiology
• Decision Date: Jan 23, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.3255
• Device Class: Class 1

Intended Use

The Duopath® Verotoxins GLISA test is a rapid test for the qualitative identification of Verotoxins I and II produced by E. coli isolated in cultures. The test aids in the diagnosis of diseases caused by enterohemorrhagic E. coli infections.

Device Story

Immunochromatographic rapid test (GLISA) for qualitative detection of Verotoxins I and II from bacterial culture isolates. Input: bacterial culture sample applied to port. Operation: gold-labeled monoclonal antibodies bind verotoxins; complex migrates chromatographically along cellulose nitrate membrane; binds to immobilized monoclonal antibodies. Output: visual red line in test window (VT1, VT2) indicates presence of toxin; red line in control window confirms proper wicking. Used in clinical laboratory settings. Results interpreted visually by laboratory personnel to aid diagnosis of enterohemorrhagic E. coli infections.

Clinical Evidence

No clinical data provided; device is a serological reagent test for in vitro diagnostic use.

Technological Characteristics

Lateral flow immunochromatographic assay; qualitative detection of Verotoxins I and II; in vitro diagnostic reagent; manual test format.

Indications for Use

Indicated for the qualitative identification of Verotoxins I and II produced by E. coli isolated in cultures to aid in the diagnosis of enterohemorrhagic E. coli infections.

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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Image /page/0/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, with three intertwined snakes and wings at the top. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the caduceus.

Public Health Service

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

JAN 2 3 2004

Ms. Anna G. Bentley Vice President, RA/QA EMD Chemicals Inc. 480 South Democrat Road Gibbstown, NJ 08027

Re: k031367

Trade/Device Name: Duopath® Verotoxins GLISA test Regulation Number: 21 CFR 866.3255 Regulation Name: Escherichia coli serological reagents Regulatory Class: Class I Product Code: GNA Dated: January 19, 2004 Received: January 20, 2004

Dear Ms. Bentley:

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 Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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 complics 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 Parts 801 and 809); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).

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This letter will allow you to begin marketing your device as described in your Section 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 information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act 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.

Sarantis

Sally A. Hojvat, M.Sc., Ph.D. Director Division of Microbiology Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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## Indications for Use

KO31367 510(k) Number (if known):

Duopath® Verotoxin GLISA Test Device Name:__________________________________________________________________________________________________________________________________________________________________

Indications For Use:

The Duopath® Verotoxins GLISA test is a rapid test for the qualitative identification of The Duopath® Verotoxins) produced by E. coli isolated in cultures derived verotoxins Fand if (Onlya like toking) promotion aids in the diagnosis of diseases caused by enterohemorrhagic E. coli infections.

Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Division Sign-Off

Tegart

Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) Ko 3, 3i]