PROSPECT SHIGA TOXIN MICROPLATE ASSAY

K980507 · Alexon - Trend, Inc. · GMZ · Apr 23, 1998 · Microbiology

Device Facts

• Record ID: K980507
• Device Name: PROSPECT SHIGA TOXIN MICROPLATE ASSAY
• Applicant: Alexon - Trend, Inc.
• Product Code: GMZ · Microbiology
• Decision Date: Apr 23, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.3255
• Device Class: Class 1

Intended Use

The ProSpecT® Shiga Toxin Microplate Assay is an in vitro microwell EIA for the qualitative detection of Shiga Toxins (Stx 1 and Stx 2) in aqueous extracts of fecal specimens and fecal enriched broth cultures. ProSpecT® Shiga Toxin Microplate Assay is intended for use as an aid in the diagnosis of enterohemorrhagic E.coli ( EHEC) infections.

Device Story

ProSpecT® Shiga Toxin Microplate Assay is an in vitro microwell enzyme immunoassay (EIA) used in clinical laboratories. It detects Shiga Toxins (Stx 1 and Stx 2) in aqueous extracts of fecal specimens or fecal enriched broth cultures. The assay utilizes immunological binding principles to identify the presence of toxins. Results are interpreted by laboratory personnel to aid in the diagnosis of enterohemorrhagic E. coli (EHEC) infections. The output provides qualitative information regarding the presence of Shiga toxins, assisting clinicians in confirming EHEC infection, which informs patient management and treatment decisions.

Clinical Evidence

No clinical data provided in the document.

Technological Characteristics

Microwell enzyme immunoassay (EIA) for qualitative detection of Shiga toxins. In vitro diagnostic device. No specific materials, energy sources, or software algorithms described.

Indications for Use

Indicated for qualitative detection of Shiga Toxins (Stx 1 and Stx 2) in fecal specimens and fecal enriched broth cultures to aid in diagnosis of enterohemorrhagic E. coli (EHEC) infections. For prescription use.

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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APR 23 1998

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Barbara Chiponis, MT (ASCP) VP. Regulatory Affairs Alexon-Trend 14000 Unity Street, N.W. Ramsey, MN 55303-9115

Re: K980507

Trade Name: ProSpect® Shiga Toxin Microplate Assay Regulatory Class: II Product Code: GMZ Dated: February 5, 1998 Received: February 10, 1998

## Dear Ms. Chiponis:

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 (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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510(k) Number: K980507

Device Name: ProSpecT®Shiga Toxin Microplate Assay

## INDICATIONS FOR USE:

The ProSpecT® Shiga Toxin Microplate Assay is an in vitro microwell EIA for the qualitative detection of Shiga Toxins (Stx 1 and Stx 2) in aqueous extracts of fecal specimens and fecal enriched broth cultures. ProSpecT® Shiga Toxin Microplate Assay is intended for use as an aid in the diagnosis of enterohemorrhagic E.coli ( EHEC) infections.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

Over-The-Counter Use OR

(Optional Format 1-2-96)

Clara Weir

(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number. 980507

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