IMMUNOCARD STAT! E. COLI O157 PLUS

K023599 · Meridian Bioscience, Inc. · GMZ · Jan 3, 2003 · Microbiology

Device Facts

• Record ID: K023599
• Device Name: IMMUNOCARD STAT! E. COLI O157 PLUS
• Applicant: Meridian Bioscience, Inc.
• Product Code: GMZ · Microbiology
• Decision Date: Jan 3, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.3255
• Device Class: Class 1

Intended Use

The ImmunoCard STAT! E.coli O157 Plus is a rapid test for the detection of antigens from shiga toxin producing E.coli O157 as an aid in the diagnosis of E.coli O157:H7 infection. The test can be used to directly test stool specimens, stool in modified Cary-Blair medium or confirmatory stool cultures grown in MacConkey broth or sorbitol MacConkey (SMAC) plates.

Device Story

ImmunoCard STAT! E. coli O157 Plus is a rapid, lateral flow immunoassay for qualitative detection of E. coli O157 antigens. Input samples include human stool specimens, stool in modified Cary-Blair medium, or bacterial growth from MacConkey broth or SMAC plates. Device utilizes specific antibodies to capture and detect O157 antigens, producing a visual signal on a test card. Intended for use in clinical laboratory settings by trained personnel. Results serve as an aid in diagnosing E. coli O157:H7 infections, facilitating timely clinical management and infection control decisions.

Clinical Evidence

No clinical data provided in the document; substantial equivalence is based on performance characteristics and intended use.

Technological Characteristics

Lateral flow immunoassay; utilizes antibody-antigen binding for detection; manual test card format; no electronic components or software.

Indications for Use

Indicated for the detection of shiga toxin producing E. coli O157 antigens in stool specimens, stool in modified Cary-Blair medium, or confirmatory stool cultures (MacConkey broth or SMAC plates) to aid in the diagnosis of E. coli O157:H7 infection.

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 is a seal for the Department of Health & Human Services - USA. The seal is circular and contains the department's logo, which is a stylized image of an eagle with three lines representing its wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the perimeter of the circle.

ood and Drug Administration 2098 Gaither Road Rockville MD 20850

JAN 0 3 2003

Susan Rolih, MS, MT (ASCP) SBB, CLA Vice President of Regulatory Affairs and Ouality Assurance Meridian Bioscience, Inc. 3471 River Hills Drive Cincinnati, OH 45244

Re: k023599

> Trade/Device Name: ImmunoCard STAT! E. coli 0157 Plus Regulation Number: 21 CFR 866.3255 Regulation Name: Escherichia Coli Serological Reagents Regulatory Class: Class I Product Code: GMZ Dated: October 25, 2002 Received: October 28, 2002

Dear Ms. Rolih:

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 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 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). 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 Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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510(k) Number: K023599

Device Name: ImmunoCard STAT! E.coli 0157 Plus

Indications For Use:

The ImmunoCard STAT! E.coli O157 Plus is a rapid test for the detection of antigens from shiga toxin producing E.coli O157 as an aid in the diagnosis of E.coli O157:H7 infection. The test can be used to directly test stool specimens, stool in modified Cary-Blair medium or confirmatory stool cultures grown in MacConkey broth or sorbitol MacConkey (SMAC) plates.

Concurrence of CDRH, Office of Device Evaluation (ODE)

Peter Harris for Freddie Prole

(Division Sign-Off) Division of Clinical Laboratory Devices 510(k) Number

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(Optional Format 3-10-98)