PROSPECT CAMPYLOBACTER MICROPLATE ASSAY by ALEXON - TREND, INC.

The ProSpecT® Campylobacter Microplate Assay is an in vitro microplate EIA for the qualitative detection of Campylobacter Specific Antigen in fecal specimens and broth enriched fecal cultures. ProSpecT Campylobacter Microplate Assay is intended for use as an aid in the diagnosis of Campylobacter infections.

Device Description

in vitro microplate EIA for the qualitative detection of Campylobacter Specific Antigen

AI/ML Overview

Based on the provided text, the document is a 510(k) clearance letter for the ProSpecT® Campylobacter Microplate Assay. It does not contain the detailed study information required to answer all aspects of your request. The letter only confirms that the device is substantially equivalent to a legally marketed predicate device.

Therefore, many of the requested details about acceptance criteria and study design are not present in this document.

However, I can extract the following:

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria: Not explicitly stated in this document. The focus of this letter is substantial equivalence to a predicate device, not a performance report against specific criteria.
Reported Device Performance: Not detailed in this document. The letter indicates the device is cleared for "qualitative detection of Campylobacter Specific Antigen" but does not provide sensitivity, specificity, or other performance metrics.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not available in the provided document.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not available in the provided document.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not available in the provided document.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

This type of study is not applicable as the device is an in vitro diagnostic assay, not an AI-powered image analysis tool for human readers. This information is not available in the provided document.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

The device is described as a "microplate EIA," which is a lab-based assay, implying it functions in a "standalone" manner (i.e., the device itself performs the detection) rather than requiring continuous human-in-the-loop performance for each test result interpretation beyond standard laboratory procedures. However, the specific details of a "standalone performance study" in the context of your question are not provided.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

This information is not available in the provided document. For an in vitro diagnostic for infectious disease, typical ground truth would involve culture methods, PCR, or other established diagnostic tests.

8. The sample size for the training set

This information is not available in the provided document. For an in-vitro diagnostic assay, the concept of a "training set" in the machine learning sense is generally not applicable in the same way. The development and validation involve different types of sample sets.

9. How the ground truth for the training set was established

This information is not available in the provided document.

In summary, the provided FDA 510(k) clearance letter confirms the regulatory approval of the ProSpecT® Campylobacter Microplate Assay for its stated indications for use but does not delve into the detailed performance study data, acceptance criteria, or ground truth establishment methodologies that would be found in a more comprehensive clinical study report.

Summary

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Public Health Service

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NOV 1 8 100

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Mr. Ken Hood Director of Regulatory Affairs Alexon-Trend, Inc. 14000 Unity Street NW Ramsey, Minnesota 55303-9115

Re: K982315/S2

ProSpecT® Campylobacter Microplate Assay Trade Name: Requlatory Class: I Product Code: LQP Dated: November 2, 1998 Received: November 3, 1998

Dear Mr. Hood:

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 Requlations, 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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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 (301) 443-6597, or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

Steven Gutman

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 K982315

Device Name: ProSpecT® Campylobacter 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)

	Woody Defors
(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number	K98 2315

Prescription Use (Per 21 CFR 801.109)

Over-The Counter Use __

( Optional Format 1-2-96)

Regulation Number and Section

§ 866.3110

Campylobacter fetus serological reagents.(a)
Identification. Campylobacter fetus serological reagents are devices that consist of antisera conjugated with a fluorescent dye used to identifyCampylobacter fetus from clinical specimens or cultured isolates derived from clinical specimens. The identification aids in the diagnosis of diseases caused by this bacterium and provides epidemiological information on these diseases.Campylobacter fetus is a frequent cause of abortion in sheep and cattle and is sometimes responsible for endocarditis (inflammation of certain membranes of the heart) and enteritis (inflammation of the intestines) in humans.(b)
Classification. Class I (general controls).