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K Number
K964887
Device Name
VIDAS C. DIFFICILE TOXIN A II ASSAY
Manufacturer
BIOMERIEUX VITEK, INC.
Date Cleared
1997-04-08

(123 days)

Product Code
LLH
Regulation Number
866.2660
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The VIDAS C. difficile Toxin A II assay detects the presence of C. difficile toxin A. It is substantially equivalent to the Meridian Premier C. difficile Toxin A test as an aid in the diagnosis of Clostridium difficile associated disease (CDAD).
Device Description
The VIDAS C. difficile Toxin A II assay detects the presence of C. difficile toxin A.
More Information

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No
The summary describes a laboratory assay for detecting a specific toxin and does not mention any AI or ML components.

No
The assay is for diagnosis, not treatment.

Yes

The "Intended Use / Indications for Use" states that the assay is "an aid in the diagnosis of Clostridium difficile associated disease (CDAD)," which directly indicates a diagnostic purpose.

No

The device is described as an "assay" and involves detecting the presence of a substance (C. difficile toxin A), which strongly suggests it is a laboratory test kit or system involving reagents and potentially hardware for analysis, not purely software. The performance studies also focus on analytical metrics like sensitivity, specificity, and precision, typical of in vitro diagnostic (IVD) assays.

Yes, this device is an IVD (In Vitro Diagnostic).

Here's why:

  • Intended Use: The "Intended Use / Indications for Use" section explicitly states that the assay "detects the presence of C. difficile toxin A" and is used "as an aid in the diagnosis of Clostridium difficile associated disease (CDAD)." This clearly indicates that the device is intended to be used in vitro (outside the body) to examine specimens (likely stool samples, though not explicitly stated) to provide information for diagnostic purposes.
  • Device Description: The "Device Description" reinforces that it "detects the presence of C. difficile toxin A," which is a biological marker.
  • Performance Studies: The description of performance studies involving "specimens" and comparing results to other diagnostic tests further confirms its use in analyzing biological samples for diagnostic purposes.

The core function of the device is to analyze a biological sample to detect a specific substance (C. difficile toxin A) to aid in the diagnosis of a disease. This is the definition of an In Vitro Diagnostic device.

N/A

Intended Use / Indications for Use

The VIDAS C. difficile Toxin A II assay detects the presence of C. difficile toxin A. It is substantially equivalent to the Meridian Premier C. difficile Toxin A test as an aid in the diagnosis of Clostridium difficile associated disease (CDAD).

Product codes

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Device Description

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Mentions image processing

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Mentions AI, DNN, or ML

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Input Imaging Modality

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Anatomical Site

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Indicated Patient Age Range

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Intended User / Care Setting

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Description of the training set, sample size, data source, and annotation protocol

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Description of the test set, sample size, data source, and annotation protocol

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Summary of Performance Studies

  • False positive results: In studies comparing the VIDAS C. difficile Toxin A II assay to a commercially available EIA with discrepants resolved by cytotoxicity, of the 1.407 negative specimens there were 13 false positive results for a specificity of 99.1%.
  • False negative results: In studies comparing the VIDAS C. difficile Toxin A II assay to a commercially available EIA with discrepants resolved by cytotoxicity, of the 136 positive specimens there were 7 false negative results for a sensitivity of 94.9%.
  • Equivocal results: The occurrence of equivocals with the VIDAS CDA 2 test was 2.5% in the studies done to demonstrate the performance of the assay. All equivocals were resolved with the use of the VIDAS C. difficile Blocking Reagents in the VIDAS CDB test of the VIDAS C. difficile Toxin A II assay.
  • Invalid results: In the studies done to support the VIDAS C. difficile Toxin A II assay performance claims, there were no invalid VIDAS results.
  • Precision: In the studies done to support the VIDAS C. difficile Toxin A II assay performance claims, the VIDAS CDA 2 test intra-assay precision testing showed coefficients of variation for test values ranging from 2.7 to 31.9 % when utilizing stool precision pools. For the VIDAS CDB test intra-assay precision testing showed coefficients of variation for test values ranging from 19.0 to 39.2 %. When utilizing the same stool precision pools, the VIDAS CDA 2 test inter-assay precision testing gave coefficients of variation for the test values ranging from 8.6 to 30.8% and coefficients of variation for the test values ranging from 9.1 to 33.4% for the VIDAS CDB test.
  • Assay Specificity: A panel of normal human colonic flora was tested for both crossreactivity and interference for the VIDAS C. difficile Toxin A II assay. Crossreactivity and interference was seen with the C. sordellii strain (VPI #9048) when tested at a concentration of 3 x 10 organisms/ml and the C. difficile toxin producing strains (ATCC #9689 and VPI # 10463) when tested at a concentration of 1 x 10' organisms/ml.

Key Metrics

  • Specificity: 99.1%
  • Sensitivity: 94.9%

Predicate Device(s)

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Reference Device(s)

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Predetermined Change Control Plan (PCCP) - All Relevant Information

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§ 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.

0

K96 4887

APR - 8 1997

SUMMARY: Safety and Effectiveness Information for the VIDAS C. difficile Toxin A II assay

The VIDAS C. difficile Toxin A II assay detects the presence of C. difficile toxin A. It is substantially equivalent to the Meridian Premier C. difficile Toxin A test as an aid in the diagnosis of Clostridium difficile associated disease (CDAD). Safety and effectiveness issues for qualitative enzyme immunoassay such as the VIDAS C. difficile Toxin A II assay may include the following:

    1. False positive results: In studies comparing the VIDAS C. difficile Toxin A II assay to a commercially available EIA with discrepants resolved by cytotoxicity, of the 1.407 negative specimens there were 13 false positive results for a specificity of 99.1%.
    1. False negative results: In studies comparing the VIDAS C. difficile Toxin A II assay to a commercially available EIA with discrepants resolved by cytotoxicity, of the 136 positive specimens there were 7 false negative results for a sensitivity of 94.9%.
    1. Equivocal results: The occurrence of equivocals with the VIDAS CDA 2 test was 2.5% in the studies done to demonstrate the performance of the assay. All equivocals were resolved with the use of the VIDAS C. difficile Blocking Reagents in the VIDAS CDB test of the VIDAS C. difficile Toxin A II assay.
    1. Invalid results: In the studies done to support the VIDAS C. difficile Toxin A II assay performance claims, there were no invalid VIDAS results.
    1. Precision: In the studies done to support the VIDAS C. difficile Toxin A II assay performance claims, the VIDAS CDA 2 test intra-assay precision testing showed coefficients of variation for test values ranging from 2.7 to 31.9 % when utilizing stool precision pools. For the VIDAS CDB test intra-assay precision testing showed coefficients of variation for test values ranging from 19.0 to 39.2 %. When utilizing the same stool precision pools, the VIDAS CDA 2 test inter-assay precision testing gave coefficients of variation for the test values ranging from 8.6 to 30.8% and coefficients of variation for the test values ranging from 9.1 to 33.4% for the VIDAS CDB test.
    1. Assay Specificity: A panel of normal human colonic flora was tested for both crossreactivity and interference for the VIDAS C. difficile Toxin A II assay. Crossreactivity and interference was seen with the C. sordellii strain (VPI #9048) when tested at a concentration of 3 x 10 organisms/ml and the C. difficile toxin producing strains (ATCC #9689 and VPI # 10463) when tested at a concentration of 1 x 10' organisms/ml.

The VIDAS C. difficile Toxin A II assay must be used according to package insert instructions when testing for the presence of C. difficile toxin A. Additional information and references may be found in the package insert.