(113 days)
The TOX A/B TEST is an enzyme immunoassay for the detection of toxins A and B produced by toxigenic strains of Clostridium difficile. It can be used to detect toxins A and B in fecal specimens from persons suspected of having C. difficile disease. The test is to be used as an aid in the diagnosis of C. difficile disease and results should be considered in conjunction with the patient history. FOR IN VITRO DIAGNOSTIC USE.
The TOX A/B TEST is an enzyme immunoassay.
The TechLab TOX A/B TEST is an enzyme immunoassay designed for the detection of toxins A and B produced by toxigenic strains of Clostridium difficile. It is intended for use with fecal specimens from individuals suspected of having C. difficile disease, serving as an aid in diagnosis, with results to be considered alongside the patient's history.
Here is the requested information regarding the acceptance criteria and the study that proves the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (Stated Goal) | Reported Device Performance |
|---|---|
| Specificity for toxins A and B of C. difficile (or equivalent toxins of toxigenic C. sordellii) and no reaction with non-toxigenic C. difficile or normal intestinal flora/enteric pathogens. | The TOX A/B TEST is specific for toxins A and B of Clostridium difficile or the equivalent toxins of toxigenic C. sordellii. The test does not react with antigens from nontoxigenic strains of C. difficile or antigens from members of the normal intestinal flora or enteric pathogens. |
| Sensitivity | 92% |
| Specificity | 100% |
| Predictive Positive Value | 100% |
| Predictive Negative Value | 99% |
| Correlation with gold standard tissue culture test | > 98% |
| Test completion within 1 hour | Can be completed within 1 hour |
| Minimizes number of steps, easy to use | Minimizes the number of steps needed, making it easy to use. |
| Does not require an indeterminate zone | An indeterminate zone is not needed, thus simplifying the interpretation of test results. |
2. Sample Size Used for the Test Set and Data Provenance:
The document does not explicitly state the sample size used for the test set or the country of origin of the data. It also does not specify if the data was retrospective or prospective.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
The document does not provide information on the number of experts used or their qualifications.
4. Adjudication Method for the Test Set:
The document does not mention any adjudication method used for the test set.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
No, an MRMC comparative effectiveness study was not described. The study focuses on the performance of the device against a gold standard, not on human reader performance with or without AI assistance.
6. Standalone Performance Study:
Yes, a standalone (algorithm only without human-in-the-loop performance) study was performed. The reported sensitivity, specificity, predictive values, and correlation against a "gold standard" tissue culture test represent the standalone performance of the TOX A/B TEST.
7. Type of Ground Truth Used:
The type of ground truth used was the "gold standard" tissue culture test.
8. Sample Size for the Training Set:
The sample size for the training set is not mentioned in the provided text.
9. How the Ground Truth for the Training Set Was Established:
The document does not provide information on how the ground truth for the training set was established. It only refers to the "gold standard" tissue culture test for evaluation.
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6. SMDA INFORMATION
510(k), TECHLAB TOX A/B TEST
KA71182
JUL 22 1997
510(k) Summary 6.1
The purpose of this study was to evaluate the TOX A/B TEST developed by TechLab. Our evaluation demonstrates the following:
- The TOX A/B TEST is specific for toxins A and B of Clostridium difficile or the equivalent toxins of toxigenic C. sordellii. The test does not react with antigens from nontoxigenic strains of C. difficile or antigens from members of the normal intestinal flora or enteric pathogens.
- · The TOX A/B TEST exhibits a sensitivity and specificity of 92% and 100%, respectively, when compared with the "gold standard" tissue culture test. It demonstrates predictive positive and negative values of 100% and 99%, respectively, and a correlation of > 98% when compared with the tissue culture test.
- The TOX A/B TEST can be completed within 1 hour, providing the clinical laboratory with rapid and reliable results.
- · The TOX A/B TEST minimizes the number of steps needed, making it easy to use.
- · The TOX A/B TEST has been optimized so that an indeterminate zone is not needed, thus simplifying the interpretation of test results.
In summary, the TOX A/B TEST represents a new test that offers the advantages of improved performance and ease-of-use over existing C. difficile tests.
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Food and Drug Administration 2098 Gaither Road Rockville MD 20850
David M. Lyerly, Ph.D. Techlab, Inc. 1861 Pratt Drive Corporate Research Center Blacksburg, VA 24060
JUL 2 2 1997
Re: K971182 Trade Name: Tox A/BTest Regulatory Class: I Product Code: LLH Dated: June 6, 1997 Received: June 9, 1997
Dear Dr. Lyerly:
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 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 Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP 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 Putman
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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2. STATEMENT OF INTENDED USE
510(k) Number (if known): Not known
Device Name: TOX A/B TEST
Indications For Use:
The TOX A/B TEST is an enzyme immunoassay for the detection of toxins A and B produced by toxigenic strains of Clostridium difficile. It can be used to detect toxins A and B in fecal specimens from persons suspected of having C. difficile disease. The test is to be used as an aid in the diagnosis of C. difficile disease and results should be considered in conjunction with the patient history. FOR IN VITRO DIAGNOSTIC USE.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use V (Per 21 CFR 801.109)
OR
Over-The Counter Use
(Optional Format 1-2-95)
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(Division Sign-Off) Division of Clinical Laboratory Devices 510(k) Number
§ 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.