PROSPECT SHIGA TOXIN MICROPLATE ASSAY by ALEXON - TREND, INC.

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 Description

Not Found

AI/ML Overview

This looks like a 510(k) clearance letter from the FDA for a diagnostic device. Unfortunately, clearance letters typically do not contain the detailed study results, acceptance criteria, or performance data that you are requesting. They primarily state that the device has been found substantially equivalent to a legally marketed predicate device.

To get the information you're asking for, one would typically need to refer to the 510(k) summary or the full 510(k) submission document itself, which is often much more detailed. These documents would contain the clinical study design, acceptance criteria, and performance outcomes.

Based solely on the provided text, I cannot provide the requested information. The document only confirms the device's clearance and its intended use.

If you had the 510(k) summary or the full submission document, I would be looking for sections that detail:

Clinical Performance Studies: This is where the bulk of the requested information would be found.
Performance Characteristics: Typically a summary of sensitivity, specificity, accuracy, etc.
Study Design: Details on population, sample size, ground truth, etc.
Acceptance Criteria: Predetermined thresholds for performance metrics.

Summary

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Image /page/0/Picture/2 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features the department's name encircling a symbol. The symbol consists of a stylized caduceus-like design with three abstract, wave-like forms. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" is arranged around the circular edge of the seal.

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 (770)488-7655.

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 (301) 594-4588. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 (800) 638-2041 or at (301) 443-6597 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:

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

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

SK=S7

Regulation Number and Section

§ 866.3255

Escherichia coli serological reagents.(a)
Identification. Escherichia coli serological reagents are devices that consist of antigens and antisera used in serological tests to identifyEscherichia coli from cultured isolates derived from clinical specimens. Additionally, some of these reagents consist ofEscherichia coli antisera conjugated with a fluorescent dye used to identifyEscherichia 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 genusEscherichia, and provides epidemiological information on diseases caused by this microorganism. AlthoughEscherichia 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.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 866.9.