C. DIFFICILE TOX A/B II

K030404 · Techlab, Inc. · LLH · Apr 24, 2003 · Microbiology

Device Facts

• Record ID: K030404
• Device Name: C. DIFFICILE TOX A/B II
• Applicant: Techlab, Inc.
• Product Code: LLH · Microbiology
• Decision Date: Apr 24, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.2660
• Device Class: Class 1

Indications for Use

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 Story

C. DIFFICILE TOX A/B II is an enzyme-linked immunoassay (ELISA) for detecting C. difficile toxins A and B in fecal samples. It functions either manually or via the Adaltis Personal Lab Jr. automated microplate analyzer. The system processes samples to produce qualitative results, which clinicians use alongside patient history to diagnose C. difficile disease. The device is intended for in vitro diagnostic use in clinical laboratory settings.

Clinical Evidence

Bench testing only. The device was evaluated using pre-characterized fecal samples tested manually and on four Adaltis Personal Lab Jr. automated systems by three different operators. Results demonstrated a positive sample correlation of >97% and a negative sample correlation of >99% between manual and automated methods.

Technological Characteristics

Enzyme-linked immunoassay (ELISA) for detection of toxins A and B. Compatible with manual or automated microplate analyzer (Adaltis Personal Lab Jr.).

Indications for Use

Indicated for detection of C. difficile toxins A and B in fecal specimens from patients suspected of having C. difficile disease.

Regulatory Classification

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.

Predicate Devices

• K003306
• K971182
• K971761

Submission Summary (Full Text)

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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 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. 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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## Page 2 -

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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## STATEMENT OF INTENDED USE 2.0

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

Device Name: C. DIFFICILE TOX A/B II

Indications For Use:

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.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

1 2 2 1 2 1 2 1 1

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)