C. DIFFICILE TOX A/B II by TECHLAB, INC.

The C. DIFFICILE TOX A/B II test is an enzyme immunoassay for the detection of toxins A and B produced by toxigenic strains of Clostridium difficile in fecal specimens from persons suspected of having C. difficile disease and results should be considered in conjunction with the patient history. The test may be performed using either manual or automated (PersonalLab Junior, Adaltis U.S. Inc.) methods. FOR IN VITRO DIAGNOSTIC USE.

Device Description

The C. DIFFICILE TOX A/B II test is an enzyme-linked immunoassay for the detection of toxins A and B in fecal specimens from patients suspected of having C. difficile disease and can be used either manually or with the Adaltis Personal Lab Jr. automated microplate analyzer system for ease of use. The subject test kit is an enzyme-linked immunoassay and has not been modified from the predicate device (K003306 and K971182). It has no technological differences from the prior 510(k) applications. The automated microplate analyzer system was not modified for use with this assay.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the C. DIFFICILE TOX A/B II test, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Criterion	Acceptance Criteria (Not Explicitly Stated, Inferred from Results)	Reported Device Performance (Manual vs. Automated)
Positive sample correlation	High correlation (implied > 97%)	> 97%
Negative sample correlation	High correlation (implied > 99%)	> 99%

Note: The document doesn't explicitly state "acceptance criteria" but rather presents the results of the correlation study as evidence of equivalence.

2. Sample Size Used for the Test Set and Data Provenance

Sample Size: Not explicitly stated, the text mentions "pre-characterized fecal samples." The exact number is not provided.
Data Provenance: The origin of the fecal samples (e.g., country) is not mentioned.
Retrospective or Prospective: Not explicitly stated whether the samples were collected retrospectively or prospectively. The term "pre-characterized" suggests they were likely existing samples with known C. difficile status.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts

This information is not provided in the given text.

4. Adjudication Method for the Test Set

This information is not provided in the given text.

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

A MRMC comparative effectiveness study was not done.
The study described compares the performance of the manual method of the C. DIFFICILE TOX A/B II test with its automated method using the Adaltis Personal Lab Jr. It does not involve human readers interpreting results with or without AI assistance. This device is an in-vitro diagnostic test for detecting toxins, not an imaging or interpretive AI device.

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

The study could be considered a form of standalone performance assessment for the automated method in comparison to the manual method. The automated system is designed to perform the assay without human interpretation of the assay's internal biochemical reactions, though a human operator would still load samples and review final results. The comparison is between two ways of running the same assay, not an AI interpreting data.

7. The Type of Ground Truth Used

The ground truth was based on "pre-characterized fecal samples." This implies that the C. difficile status (presence or absence of toxins A and B) in these samples was previously established using a gold standard or a highly reliable method, although the specific method is not detailed (e.g., culture, another FDA-cleared test).

8. The Sample Size for the Training Set

This information is not applicable as this device does not describe an AI or machine learning algorithm that requires a training set. The study describes the performance of a diagnostic assay being run on an automated platform.

9. How the Ground Truth for the Training Set was Established

This information is not applicable as this device does not describe an AI or machine learning algorithm that requires a training set with established ground truth.

Summary

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APR 2 5 2003

K030404

Summary of Safety and Effectiveness

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.

The assigned 510(k) number is: K030404.

This product, C. DIFFICILE TOX A/B II test, was used with the Adaltis Personal Lab Jr, automated microplate analyzer system.

The equivalent predicate device 510(k) numbers are K003306, K971182, and K971761 respectively.

The subject test kit is an enzyme-linked immunoassay and has not been modified from the predicate device (K003306 and K971182). It has no technological differences from the prior 510(k) applications.

The automated microplate analyzer system was not modified for use with this assay. The K971761 510(k) describes the software validation study, which has not been modified for this assay.

The C. DIFFICILE TOX A/B II test was tested with pre-characterized fecal samples both manually and with four of the same model of automated microplate analyzer system by three different people. The results of these evaluations show a positive sample correlation of > 97% and a negative sample correlation of > 99% between the manual and automated methods.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three lines representing its wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the eagle.

Public Health Service

APR 2 5 2003

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Mr. David A. Wall Vice-President of Operations TECHLAB, Inc. VPI Research Park 1861 Pratt Drive, Suite 1030 Blacksburg, VA 24060-6364

K030404 Re:

Trade/Device Name: C. Difficile Tox A/B II Regulation Number: 21 CFR 866.2660 Regulation Name: Microorganism Differentiation and Identification Device Regulatory Class: Class I Product Code: LLH Dated: February 5, 2003 Received: February 6, 2003

Dear Mr. Wall:

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 (301) 594-3084. 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 (800) 638-2041 or (301) 443-6597 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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STATEMENT OF INTENDED USE 2.0

510(k) Number (if known): K 30404 . . . - -

Device Name: C. DIFFICILE TOX A/B II

Indications For Use:

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

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Luddite Cooley

Prescription Use V (Per 21 CFR 801.109)

Over-The Counter Use Division Sian Off Division of Clinical Laboratory Devices 510(k) Number_ L(0 30404 (Optional format 1-2-96)

Regulation Number and Section

§ 866.2660 Microorganism differentiation and identification device.

(a)
Identification. A microorganism differentiation and identification device is a device intended for medical purposes that consists of one or more components, such as differential culture media, biochemical reagents, and paper discs or paper strips impregnated with test reagents, that are usually contained in individual compartments and used to differentiate and identify selected microorganisms. The device aids in the diagnosis of disease.(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 § 866.9.