(141 days)
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No
The description details a standard automated immunoassay using ELFA technique. There is no mention of AI, ML, or any computational methods beyond automated calculation of results based on pre-defined thresholds.
No.
This device is an in vitro diagnostic (IVD) device used for the qualitative detection of Clostridium difficile toxins in stool specimens, which aids in diagnosis, but does not directly provide therapy or treatment.
Yes
The device is an automated test for the qualitative detection of Clostridium difficile toxin A and toxin B in stool specimens, providing results like "positive," "negative," or "equivocal," which are used to aid in the diagnosis of C. difficile infection.
No
The device description explicitly mentions hardware components like the VIDAS instruments, Solid Phase Receptacle (SPR), and reagent strips (STRs), which are integral to the assay's function.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states it's for the "qualitative detection of Clostridium difficile toxin A and toxin B in stool specimens." This is a diagnostic test performed on a biological sample (stool) outside of the body (in vitro).
- Device Description: The description details an "automated test" using an "ELFA technique" and "reagents" to analyze a "sample" (stool). This aligns with the definition of an in vitro diagnostic device.
- Anatomical Site: The test is performed on "Stool specimens," which are biological samples.
- Performance Studies: The document includes performance studies comparing the device to a "Predicate Device," which is common for IVD submissions to regulatory bodies.
All of these points strongly indicate that the VIDAS® C. difficile Toxin A & B (CDAB) assay is an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
VIDAS® C. difficile Toxin A & B (CDAB) assay is an automated test for use on the VIDAS instruments for the qualitative detection of Clostridium difficile toxin A and toxin B in stool specimens using the ELFA technique (Enzyme-Linked Fluorescent Assay).
Product codes (comma separated list FDA assigned to the subject device)
LLH
Device Description
VIDAS® C. difficile Toxin A & B (CDAB) assay is an automated test for use on the VIDAS instruments for the qualitative detection of Clostridium difficile toxin A and toxin B in stool specimens using the ELFA technique (Enzyme-Linked Fluorescent Assay).
The assay principle combines a two-step enzyme immunoassay sandwich method with a final fluorescent detection (ELFA). The Solid Phase Receptacle (SPR), a pipette tip-like device, serves as the solid phase as well as the pipetting device for the assay. The assay reagents are ready-to-use and pre-dispensed in the sealed reagent strips (STRs). The individual kit components are described in detail on the following pages.
Each of the four reaction steps are performed automatically by the VIDAS instrument. The reaction medium (sample/conjugate mixture) is cycled in and out of the SPR several times. Each step is followed by a wash cycle which eliminates unbound components.
- Step 1: Toxin A and/or toxin B present in the sample binds with the anti-toxin A antibodies (rabbit polyclonal) and anti-toxin B antibodies (mouse monoclonal) coated on the interior wall of the SPR.
- Binding between toxin A and anti-toxin A antibodies (mouse monoclonal) conjugated Step 2: with biotin. Binding between toxin B and anti-toxin B antibodies (mouse monoclonal) conjugated with biotin.
- The presence of biotin is detected by incubation with streptavidin conjugated with Step 3: alkaline phosphatase.
- Alkaline phosphatase catalyzes the hydrolysis of the substrate (4-Methyl-umbellifery) Step 4: phosphate) into a fluorescent product (4-Methyl-umbelifferone) the fluorescence of which is measured at 450 nm. The intensity of the fluorescence is proportional to the quantity of toxin A and/or toxin B present in the sample.
At the end of the VIDAS CDAB assay, results are automatically calculated by the VIDAS instrument. A test value as well as the qualitative result (positive, negative or equivocal) are provided on the result sheet for each sample.
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)
A summary of the non-clinical and clinical test results is presented in the table below.
Non-clinical (Analytical) Comparison:
Precision/Reproducibility: 6 pools of samples tested in duplicate over 6 days; total precision: 7.4 – 37.6% CV; inter-assay precision: 6.8 – 26.8% CV; intra-assay precision: 2.9 – 26.3% CV.
C. difficile strain types: A+/B+ 100% (23/23); A-/B+ 83% (15/18*) * 3 of the A-/B+ strains gave equivocal results.
Limit of Detection (stool): Toxin A at level of ≥ 7.73 ng/mL; Toxin B at level of ≥ 4.55 ng/mL.
Clinical Studies Comparison:
Number of specimen: 1011 specimen
Study Site(s): US and Europe
Results:
Positive Agreement: versus Predicate (all sites) 81.3%; 95% CI: 73.4–87.6%
Negative Agreement: 99.5%; 95% CI: 98.8 – 99.9%
Global Agreement: 97.1%; 95% CI: 95.9–98.1%
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Positive Agreement: 81.3%; 95% CI: 73.4–87.6%
Negative Agreement: 99.5%; 95% CI: 98.8 – 99.9%
Global Agreement: 97.1%; 95% CI: 95.9–98.1%
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.
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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 for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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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
077138
DEC 2 1 2007
510(k) SUMMARY
VIDAS® CDAB Assay
A. Submitter Information
| Submitter's Name:
Address: | bioMérieux, Inc.
595 Anglum Road
Hazelwood, MO 63042 |
|-----------------------------------------|----------------------------------------------------------------------------|
| Contact Person: | Nikita S. Mapp |
| Phone Number: | 314-731-7474 |
| Fax Number: | 314-731-8689 |
| Date of Preparation: | July 1, 2007 (revised Dec. 20, 2007) |
| B. Device Name
Trade Name: | VIDAS® CDAB |
| Common Name: | Clostridium difficile Enzyme Immunoassay |
| Classification Name: | 21 CFR 866.2660, Product Code LLH
Reagents, Clostridium Difficile Toxin |
| C. Predicate Device Name
Trade Name: | Meridian Premier Toxins A&B |
D. Device Description
VIDAS® C. difficile Toxin A & B (CDAB) assay is an automated test for use on the VIDAS instruments for the qualitative detection of Clostridium difficile toxin A and toxin B in stool specimens using the ELFA technique (Enzyme-Linked Fluorescent Assay).
The assay principle combines a two-step enzyme immunoassay sandwich method with a final fluorescent detection (ELFA). The Solid Phase Receptacle (SPR), a pipette tip-like device, serves as the solid phase as well as the pipetting device for the assay. The assay reagents are ready-to-use and pre-dispensed in the sealed reagent strips (STRs). The individual kit components are described in detail on the following pages.
Each of the four reaction steps are performed automatically by the VIDAS instrument. The reaction medium (sample/conjugate mixture) is cycled in and out of the SPR several times. Each step is followed by a wash cycle which eliminates unbound components.
- Step 1: Toxin A and/or toxin B present in the sample binds with the anti-toxin A antibodies (rabbit polyclonal) and anti-toxin B antibodies (mouse monoclonal) coated on the interior wall of the SPR.
1
- Binding between toxin A and anti-toxin A antibodies (mouse monoclonal) conjugated Step 2: with biotin. Binding between toxin B and anti-toxin B antibodies (mouse monoclonal) conjugated with biotin.
- The presence of biotin is detected by incubation with streptavidin conjugated with Step 3: alkaline phosphatase.
- Alkaline phosphatase catalyzes the hydrolysis of the substrate (4-Methyl-umbellifery) Step 4: phosphate) into a fluorescent product (4-Methyl-umbelifferone) the fluorescence of which is measured at 450 nm. The intensity of the fluorescence is proportional to the quantity of toxin A and/or toxin B present in the sample.
At the end of the VIDAS CDAB assay, results are automatically calculated by the VIDAS instrument. A test value as well as the qualitative result (positive, negative or equivocal) are provided on the result sheet for each sample.
E. Intended Use
VIDAS® C. difficile Toxin A & B (CDAB) assay is an automated test for use on the VIDAS instruments for the qualitative detection of Clostridium difficile toxin B in stool specimens using the ELFA technique (Enzyme-Linked Fluorescent Assay).
| Item | Device
[VIDAS CDAB] | Predicate
[Premier Toxins A&B] |
|---------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------|
| Intended Use | An automated test for use on the VIDAS
instruments for the qualitative detection of
Clostridium difficile toxin A and toxin B in
stool specimens using the ELFA technique
(Enzyme-Linked Fluorescent Assay). | Same |
| Indications for Use | Interpretation of test results should be
made taking into consideration the patient
history and any other tests performed. | Same |
| Specimen | Stool | Same |
| Assay Principle | Enzyme immunoassay | Same |
| Automated | Automated assay | Non-automated assay; requires
visual and spectrophotometric
determinations |
| Assay Technique | Enzyme-Linked Fluorescent Assay (ELFA) | Micro titer well assay |
| Antibodies | capture Anti-Toxin A (rabbit polyclonal)
Anti-Toxin B (mouse monoclonal) | Anti-Toxin A (mouse monoclonal)
Anti-Toxin B (goat polyclonal) |
| | detection Anti-Toxin A (mouse monoclonal)
Anti-Toxin B (mouse monoclonal) | Anti-Toxin A (goat polyclonal)
Anti-Toxin B (goat polyclonal) |
| Conjugate | Mouse monoclonal anti-toxin A and anti-
toxin B antibodies conjugated with biotin | Horse-radish peroxidase
conjugated to anti-toxins |
F. Technological Characteristics Summary
2
| 1200 1100 | nevice | redicate |
|---|---|---|
| Sample Volume | 200 ul (liquid stool) | |
| 200 mg (semi-solid & solid stools) | 100 ul | |
| Assav Time | ~75 minutes | ~95 minutes |
G. Performance Data
A summary of the non-clinical and clinical test results is presented in the table below.
| Item | Device
[VIDAS CDAB] | Predicate
[Premier Toxins A&B] |
|----------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------|
| Non-clinical (Analytical) Comparison | | |
| Precision/
Reproducibility | 6 pools of samples tested in duplicate over
6 days
total precision: 7.4 – 37.6% CV
inter-assay precision: 6.8 – 26.8% CV
intra-assay precision: 2.9 – 26.3% CV | Samples tested in triplicate
within run: 4.1 – 28.9% CV
btwn run: 6.2 – 31.7% CV |
| C. difficile strain types | A+/B+ 100% (23/23)
A-/B+ 83% (15/18*)
- 3 of the A-/B+ strains gave equivocal
results | A+/B+ 100% (25/25)
A-/B+ 100% (3/3) |
| Limit of Detection (stool) | Toxin A at level of ≥ 7.73 ng/mL;
Toxin B at level of ≥ 4.55 ng/mL | Toxin A at level of ≥ 1.4 ng/mL;
Toxin B at level of ≥ 2.4 ng/mL |
| Clinical Studies Comparison | | |
| Number of specimen | 1011 specimen | unknown |
| Study Site(s) | US and Europe | US |
| Results
Positive Agreement:
Negative Agreement:
Global Agreement: | versus Predicate (all sites)
81.3%; 95% CI: 73.4–87.6%
99.5%; 95% CI: 98.8 – 99.9%
97.1%; 95% CI: 95.9–98.1% | N/A |
H. Conclusion
The VIDAS® CDAB Assay is substantially equivalent to the Meridian Premier Toxins A&B Assay.
The 510(k) summary includes only information that is also covered in the body of the 510(k). The summary does not contain any puffery or unsubstantiated labeling claims. The summary does not contain any raw data, i.e., contains only summary data. The summary does not contain any trade secret or confidential commercial information. The summary does not contain any patient identification information.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
DEC 2 1 2007
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Ms. Nikita S. Mapp Senior Regulatory Affairs Specialist bioMérieux, Inc. 595 Anglum Road Hazelwood, MO 63042
K072138 Re: Trade/Device Name: VIDAS® CDAB Regulation Number: 21 CFR 866.2660 Regulation Name: Microorganism differentiation and identification device Regulatory Class: Class I Product Code: LLH Dated: December 3, 2007 Received: December 5, 2007
Dear Ms. Mapp:
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 advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at 240-276-0450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Sally attayna
Sally A. Hoivat. M.Sc., Ph.D. Director Division of Microbiology Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known): K072138
Device Name: VIDAS® C. difficile Toxin A & B (CDAB) Assay
Indications For Use: VIDAS® C. difficile Toxin A & B (CDAB) assay is an automated test for use on the VIDAS instruments for the qualitative detection of Clostridium difficile toxin A and toxin B in stool specimens using the ELFA technique (Enzyme-Linked Flurorescent Assay).
Prescription Use _ X (21 CFR Part 801 Subpart D) And/Or
Over the Counter Use _ (21 CFR Part 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE; CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Device Evaluation and Safety (OVD)
Laudle M. Poole
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K072138