(70 days)
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No
The description details an automated immunoassay using the ELFA technique and standard performance metrics, with no mention of AI or ML.
No
This device is an in vitro diagnostic test that aids in diagnosing a condition by detecting specific toxins, rather than directly treating or preventing a disease.
Yes
The "Intended Use / Indications for Use" section states: "The VIDAS C. difficile toxin A & toxin B (CDAB) assay is an aid for diagnosing Clostridium difficile associated disease (CDAD)." This explicitly indicates its role in diagnosis.
No
The device description explicitly states it is an "automated test for use on the VIDAS instruments" and utilizes physical components like the Solid Phase Receptacle (SPR) and reagent strips (STRs), which are handled by the VIDAS instrument. This indicates it is a system involving both hardware and software, not software-only.
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 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". This describes a test performed in vitro (outside the body) on a biological specimen (stool) to provide information for diagnosis.
- Device Description: The "Device Description" further clarifies that it's an "automated test" using an "ELFA technique" on "stool specimens". This confirms the in vitro nature of the testing.
- Aid for Diagnosis: The intended use also states it is "an aid for diagnosing Clostridium difficile associated disease (CDAD)". This directly links the test results to providing diagnostic information.
These points clearly align with the definition of 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 Flurorescent Assay). The VIDAS C. difficile toxin A & toxin B (CDAB) assay is an aid for diagnosing Clostridium difficile associated disease (CDAD).
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.
- 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 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 alkaline phosphatase.
- Two detection steps are performed successively Alkaline phosphatase catalyzes the hydrolysis of the substrate (4-Methyl-umbellifery) phosphate) into a fluorescent product (4-Methyl-umbelliferone) 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)
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.
- Drug Interference: Vancomycin; Metronidazole; Loperamide; Bismuth subsalicylate; Salicylate; Barium sulfate; Imodium tablet & liquid; Pepto-Bismol tablet & liquid.
Clinical Studies Comparison:
- Number of specimens: 1011 specimens.
- Study Site(s): USA and Europe.
- Results versus CTA (all sites): Sensitivity: 88.3%; 95% CI: 81.2 – 93.5%; Specificity: 99.8 %; 95% CI: 99.2 – 99.9%; PPV: 98.1%; 95% CI: 93.5 – 99.8%; NPV: 98.4 %; 95% CI: 97.3 – 99.1%.
- Additional testing w/external site: Sensitivity: 88.0%; 95% CI: 68.8 – 97.5%; Specificity: 95.1%; 95% CI: 86.3 – 99.0%; Total Agreement: 93.0%; 95% CI: 85.4 – 97.4%.
- Results versus Predicate (all sites): 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%.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Versus CTA (all sites):
Sensitivity: 88.3%; 95% CI: 81.2 – 93.5%
Specificity: 99.8 %; 95% CI: 99.2 – 99.9%
PPV: 98.1%; 95% CI: 93.5 – 99.8%
NPV: 98.4 %; 95% CI: 97.3 – 99.1%
Additional testing w/external site:
Sensitivity: 88.0%; 95% CI: 68.8 – 97.5%
Specificity: 95.1%; 95% CI: 86.3 – 99.0%
Total Agreement: 93.0%; 95% CI: 85.4 – 97.4%
Versus Predicate (all sites):
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.
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.
Not Found
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).
Not Found
§ 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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Korn931
JUN 1 1 2008
510(k) SUMMARY
VIDAS® CDAB Assay
A. Submitter Information Submitter's Name: bioMérieux, Inc. 595 Anglum Road Address: Hazelwood, MO 63042 Contact Person: Nikita S. Mapp Associate Staff Regulatory Affairs Specialist Phone Number. 314-731-7474 314-731-8689 Fax Number. Date of Preparation: April 1, 2008 B. Device Name Trade Name: VIDAS® CDAB Clostridium difficile Enzyme Immunoassay Common Name: 21 CFR 866.2660, Product Code LLH Classification Name: Reagents, Clostridium Difficile Toxin C. Predicate Device Name VIDAS® C. difficile Toxin A & B (CDAB) assay [K072138] Trade Name:
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.
- Toxin A and/or toxin B present in the sample binds with the anti-toxin A antibodies Step 1: (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) Step 2: conjugated 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.
- Two detection steps are performed successively Alkaline phosphatase catalyzes Step 4: the hydrolysis of the substrate (4-Methyl-umbellifery) phosphate) into a fluorescent product (4-Methyl-umbelliferone) 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 Clostricium difficile toxin A and toxin B in stool specimens using the ELFA technique (Enzyme-Linked Fluorescent Assay). The VIDAS C. difficile toxin A & toxin B (CDAB) assay is an aid for diagnosing Clostridium difficile associated disease (CDAD).
| Item | Device
[VIDAS CDAB Assay - Claim Extension] | Predicate
[VIDAS CDAB Assay - K072138] |
|---------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 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). The
VIDAS C. difficile toxin A & toxin B (CDAB)
assay is an aid for diagnosing Clostridium
difficile associated disease (CDAD). | 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). |
| 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 | Same |
| Assay Technique | Enzyme-Linked Fluorescent Assay (ELFA) | Same |
| Antibodies | capture Anti-Toxin A (rabbit polyclonal)
Anti-Toxin B (mouse monoclonal) | Same |
| | detection Anti-Toxin A (mouse monoclonal)
Anti-Toxin B (mouse monoclonal) | |
F. Technological Characteristics Summary
A comparison of the similarities and differences of the assays is presented in the table below.
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| Item | Device
[VIDAS CDAB Assay – Claim Extension] | Predicate
[VIDAS CDAB Assay – K072138] |
|---------------|----------------------------------------------------------------------------------|-------------------------------------------|
| Conjugate | Mouse monoclonal anti-toxin A and anti-toxin B antibodies conjugated with biotin | Same |
| Sample Volume | 200 µl (liquid stool)
200 mg (semi-solid & solid stools) | Same |
| Assay Time | ~75 minutes | Same |
G. Performance Data
.
A summary of the non-clinical and clinical test results are 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 | Same |
| C. difficile strain types | A+/B+ 100% (23/23) | Same |
| | 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; | Same |
| | Toxin B at level of ≥ 4.55 ng/mL | |
| Drug Interference | Vancomycin; Metronidazole; Loperamide; | Not evaluated in K072138 |
| | Bismuth subsalicylate; Salicylate; Barium | |
| | sulfate; Imodium tablet & liquid; Pepto-
Bismol tablet & liquid | |
| Clinical Studies Comparison | | |
| Number of specimen | 1011 specimens | Same |
| Study Site(s) | USA and Europe | Same |
| Results | versus CTA (all sites) | Submitted in K072138 |
| | Sensitivity: 88.3%; 95% CI: 81.2 – 93.5% | |
| | Specificity: 99.8 %; 95% CI: 99.2 – 99.9% | |
| | PPV: 98.1%; 95% CI: 93.5 – 99.8% | |
| | NPV: 98.4 %; 95% CI: 97.3 – 99.1% | |
| | additional testing w/external site | N/A |
| Sensitivity: | 88.0%; 95% CI: 68.8 – 97.5% | |
| Specificity: | 95.1%; 95% CI: 86.3 – 99.0% | |
| Total Agreement: | 93.0%; 95% CI: 85.4 – 97.4% | |
| Results | versus Predicate (all sites) | Same |
| | 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% | |
:
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H. Conclusion
The VIDAS® CDAB Assay is substantially equivalent to the VIDAS CDAB Assay [K072138].
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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Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle. The eagle is black, and the text is also black. The background is white.
Public Health Service
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
JUN 1 1 2008
Ms. Nikita S. Mapp Associate Staff Regulatory Affairs Specialist bioMérieux, Inc. 595 Anglum Road Hazelwood, MO 63042
K080931 Trade/Device Name: VIDAS® CDAB Assay Regulation Number: 21 CFR § 866.2660 Regulation Name: Microorganism Differentiation and Identification Device Regulatory Class: I Product Code: LLH Dated: April 1st, 2008 Received: April 2nd, 2008
Dear Ms. Mapp:
Re:
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 idications 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 Federall Food, Dr to 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, isting 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 additions FDA may publish further announcements concerning your device in the Federal Depister.
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 practive requirements as set forth in the quality systems (QS) regulation (21 CFR Party 200).
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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 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 attayma
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
K080931 510(k) Number (if known):
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). The VIDAS C. difficile toxin A & toxin B (CDAB) assay is an aid for diagnosing Clostridium difficile associated disease (CDAD).
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 (OIVD)
Ludlow W. Poole
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K08093/