(113 days)
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No
The device description details a manual, card-based enzyme immunoassay with visual color development interpretation. There is no mention of automated analysis, image processing, or any computational methods that would suggest the use of AI/ML.
No
The device is an in vitro diagnostic test for detecting a toxin, used to aid in diagnosis, not to treat a condition.
Yes
The intended use explicitly states that the test "can be used to aid in the diagnosis of C. difficile-associated disease".
No
The device description clearly outlines a physical kit containing multiple reagents, cards, and pipets, indicating it is a hardware-based in vitro diagnostic device, not software only.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states it is a "rapid in vitro qualitative procedure for detecting Clostridium difficile toxin A in human stool." The term "in vitro" is a key indicator of an IVD, meaning it is used to test samples outside of the living body.
- Device Description: The description details a laboratory-based assay system using reagents and a card-based format to analyze a biological sample (stool). This is characteristic of an IVD.
- Anatomical Site: The sample is "human stool," which is a biological specimen collected from a human for diagnostic purposes.
- Performance Studies: The document includes performance metrics like sensitivity, specificity, and agreement, which are standard evaluations for diagnostic tests.
- Predicate and Reference Devices: The comparison to predicate and reference devices (like cytotoxin assays and other EIAs) further confirms its role as a diagnostic test.
Therefore, based on the provided information, the ImmunoCard Toxin A is clearly an In Vitro Diagnostic device.
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Intended Use / Indications for Use
The ImmunoCard Toxin A enzyme immunoassay (EIA) is a rapid in vitro qualitative procedure for detecting Clostridium difficile toxin A in human stool. The test can be used to aid in the diagnosis of C. difficile-associated disease. The test may also be used to determine the production of toxin A by C. difficile in BHI broth culture.
Product codes
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Device Description
The ImmunoCard Toxin A assay system is a card based EIA for toxin A of C. difficile. Each kit contains the following components: Toxin A ImmunoCards (50), Positive Control (0.5ml), Enzyme Conjugate (7.5ml), Sample Diluent (10.0ml), Wash Reagent (28ml), Substrate Reagent (13ml), Transfer Pipets (50).
In brief, the assay is performed by preparing a 1/15 dilution of stool in a mixture of Sample Diluent and Enzyme Conjugate. Using a transfer pipet, 150µl of diluted specimen are then added to each of the lower (sample application) ports on an ImmunoCard. The sample is allowed to enter the card for 5 minutes. Three drops of Wash Reagent are added to each of the upper (Reaction) ports and allowed to enter the card. Three drops of Substrate Reagent are then added and the card is viewed for visible blue color development after 5 minutes.
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
- Comparison with Predicate Devices: Equivalent relative performance was recorded (relative sensitivity 82.7%, relative specificity 98.2%, relative agreement 96.2%) when comparing the ImmunoCard Toxin A and cytotoxin tests. When ImmunoCard Toxin A results were compared with concordant result of 3 reference methods (Toxin A EIA, cytotoxin and toxigenic culture), sensitivity, specificity and agreement were 85.2%, 97.5% and 96.0%. These clinical data demonstrate the correlation between the two methods, supporting the ImmunoCard Toxin A EIA as being substantially equivalent to the reference cytotoxin method.
- Sensitivity Limits: The sensitivity of the ImmunoCard Toxin A is approximately 32 pg of toxin A. Allowing for the 1/15 dilution of sample and 150µl assay volume, this equates to 3.2ng toxin A/ml of stool as the ImmunoCard Toxin A limit of detection.
- Reproducibility: Reproducibility of the ImmunoCard Toxin A test was evaluated by running strong positive, weak positive, and negative stools. Ten specimens were tested in triplicate on each of 3 different days at 3 different locations. No incorrect results were obtained with any test or procedural control.
- Fresh versus Frozen Stools: The data indicated toxin A is stable in stool for at least 3 days when stored at 4°C. If specimen cannot be tested within this period, freezing the specimen is recommended (≤ -20°C) and does not appreciably alter performance.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
- Relative sensitivity: 82.7% (compared to cytotoxin test)
- Relative specificity: 98.2% (compared to cytotoxin test)
- Relative agreement: 96.2% (compared to cytotoxin test)
- Sensitivity: 85.2% (compared to 3 reference methods: Toxin A EIA, cytotoxin and toxigenic culture)
- Specificity: 97.5% (compared to 3 reference methods: Toxin A EIA, cytotoxin and toxigenic culture)
- Agreement: 96.0% (compared to 3 reference methods: Toxin A EIA, cytotoxin and toxigenic culture)
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Tissue culture cytotoxin assay with neutralization using specific anti-toxin. (While a K/DEN number is not provided, this is explicitly stated as the predicate equivalent device).
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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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.
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APR 1 8 1996 510 (k) Summary
Meridian Diagnostics, Inc. Cincinnati, Ohio 45244
APPENDIX A - 510(k) Summary
Identification Information E.
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- Submitter's Information:
- Submitter's Name and Address: a)
Meridian Diagnostics, Inc. 3471 River Hills Dr. Cincinnati, OH 45244
- b) Phone Number: 1-800-543-1980
- Contact Person: Allen D. Nickol, PhD C) Director Scientific & Regulatory Affairs
- Date Summary Prepared: December 22, 1995 d)
- Name of Device: ImmunoCard Toxin A. The ImmunoCard Toxin 2) A enzyme immunoassay (EIA) is a rapid in vitro qualitative procedure for detecting Clostridium difficile toxin A in human stool. The test can be used to aid in the diagnosis of C. difficile-associated disease. The test may also be used to determine the production of toxin A by C. difficile in BHI broth culture. Classification Name unknown.
- Tissue culture cytotoxin Predicate Equivalent Device: 3) assay with neutralization using specific anti-toxin.
- Description of Device: The ImmunoCard Toxin A assay system 4 ) is a card based EIA for toxin A of C. difficile. Each kit contains the following components:
- Toxin A ImmunoCards (50) a)
- Positive Control (0.5ml) b)
- Enzyme Conjugate (7.5ml) C)
- Sample Diluent (10.0ml) d )
- Wash Reagent (28ml) e )
- Substrate Reagent (13ml) f)
- Transfer Pipets (50) ਕੇ )
the assay is performed by preparing a In brief, 1/15 dilution of stool in a mixture of Sample Diluent and Enzyme 150pl of diluted Using a transfer pipet, Conjuqate. specimen are then added to each of the lower (sample application) ports on an ImmunoCard. The sample is allowed Three drops of Wash to enter the card for 5 minutes. Reagent are added to each of the upper (Reaction) ports and
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allowed to enter the card. Three drops of Substrate Reagent are then added and the card is viewed for visible blue color development after 5 minutes.
- The ImmunoCard Toxin A enzyme immunoassay 5) Intended Use: is a rapid in vitro qualitative procedure (EIA) for detecting Clostridium difficile toxin A in human stool. The test can be used to aid in the diagnosis of C. difficile-associated disease. The test may also be used to determine the production of toxin A by C. difficile in BHI broth culture.
- Comparison ର) Predicate Devices: with The following comparison of the use, technology, function and performance supports the Statement of Equivalence between the ImmunoCard Toxin A test and cytotoxin testing.
- a) Both assays detect toxins of C. difficile in patient stools. The ImmunoCard Toxin A test detects enterotoxin (toxin A), the etiologically important toxin. The cytotoxin assay detects toxin B, which is associated with disease through coproduction with toxin A.
- b) Both assays are in vitro immunoassays. The ImmunoCard Toxin A test is an EIA, while the cytotoxin assay is an antibody-dependent toxin neutralization bioassay.
- C) Both tests are performed directly on stool extracts. The ImmunoCard Toxin A test utilizes a Sample Diluent and Enzyme Conjuqate, while the cytotoxin assay requires sample dilution, centrifugation and filtration.
- Both assays yield qualitative results (i.e. positive or d) negative). The cytotoxin assay can be performed using higher than standard (1/40) dilutions, although the diagnostic significance of this has yet to be determined.
- Equivalent relative performance was recorded relative e) sensitivity 82.7%, relative specificity 98.2%, relative agreement 96.2%) when comparing the ImmunoCard Toxin A and cytotoxin tests. When ImmunoCard Toxin A results were compared with concordant result of 3 reference methods (Toxin A EIA, cytotoxin and toxigenic culture), sensitivity, specificity and agreement were 85.2%, 97.5% and 96.0%.
- These clinical data demonstrate the correlation between f)
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510 (k) Summary
the two methods, supporting the ImmunoCard Toxin A EIA as being substantially equivalent to the reference cytotoxin method.
Additional Information/Nonclinical Test Results: F.
- The sensitivity of the ImmunoCard 1) Sensitivity Limits: Toxin A is approximately 32 pg of toxin A. Allowing for the 1/15 dilution of sample and 150µl assay volume, this equates to 3.2ng toxin A/ml of stool as the ImmunoCard Toxin A limit of detection.
- Reproducibility: Reproducibility of the ImmunoCard Toxin A 2) test was evaluated by running strong positive, weak positive, and negative stools. Ten specimens were tested in triplicate on each of 3 different days at 3 different No incorrect results were obtained with any locations. test or procedural control.
- Fresh versus Frozen Stools: The data indicated toxin A is 3) stable in stool for at least 3 days when stored at 4°C. If specimen cannot be tested within this period, freezing the specimen is recommended (≤ -20°C) and does not appreciably alter performance.