(76 days)
No
The device description details a standard real-time PCR assay with fluorescence detection and software interpretation of the data. There is no mention of AI or ML algorithms being used for data analysis or result interpretation. The "SmartCycler® software" is described as monitoring fluorescence and providing a final result, which is typical for automated PCR systems and does not inherently imply AI/ML.
No
The device is an in vitro diagnostic test for detecting vancomycin-resistance genes, not a device used to treat or cure a disease.
Yes
The device is described as an "in vitro test for the rapid detection of vancomycin-resistance (vanA and vanB) genes directly from rectal swabs" used to "aid to identify, prevent and control vancomycin-resistant colonization in healthcare settings." While it states it's "not intended to diagnose VRE infections nor to guide or monitor treatment," its purpose of detecting specific genes to identify a condition (vancomycin resistance) aligns with the definition of a diagnostic device.
No
The device description clearly outlines the use of physical components like molecular beacons, fluorophores, and a real-time PCR instrument (SmartCycler®) for the assay. While software is used for data interpretation, the core functionality relies on hardware and chemical reactions.
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 IDI-VanR® Assay is a "qualitative in vitro test". This is a key characteristic of an IVD. It also describes the test as being performed "directly from rectal swabs," which are biological specimens.
- Device Description: The description details the process of analyzing biological material (rectal swabs) to detect specific genetic targets (vanA and vanB genes) using molecular techniques (real-time PCR and molecular beacons). This is consistent with the nature of an IVD.
- Performance Studies: The document describes clinical trials where the device's performance was evaluated against a reference method (culture technique) using patient samples (rectal swabs). This type of evaluation is standard for IVDs to demonstrate their accuracy and reliability for diagnostic purposes.
- Predicate Device: The mention of a "Predicate Device" (Remel Bile Esculin Azide agar with 6 ug/mL vancomycin (BEAV)) further indicates that this device is being compared to an existing diagnostic method, which is typical for regulatory submissions of IVDs.
In summary, the device is designed to perform a test on biological specimens outside of the body (in vitro) to provide information about a patient's health status (presence of vancomycin resistance genes), which aligns perfectly with the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The IDI-VanR® Assay is a qualitative in vitro test for the rapid detection of vancomycinresistance (vanA and vanB) genes directly from rectal swabs. The IDI-vanR® Assay detects the presence of the vanA and vanB genes that can be associated with vancomycin-resistant enterococci (VRE). The assay is performed on an automated realtime PCR instrument with rectal swabs from patients at risk for VRE colonization. The IDI-VanR® Assay can be used as an aid to identify, prevent and control vancomycinresistant colonization in healthcare settings. Concomitant cultures are necessary to recover organisms for epidemiological typing, susceptibility testing and for further confirmatory identification. The IDI-VanR® Assay is not intended to diagnose VRE infections nor to guide or monitor treatment for VRE infections.
Product codes
NIJ
Device Description
The IDI-VanR® Assay is a qualitative in vitro test for the rapid detection of vancomycinresistance (vanA and vanB) genes directly from rectal swabs. The IDI-vanR® Assav detects the presence of the vanA and vanB genes that can be associated with vancomycin-resistant enterococci (VRE). The assay is performed on an automated realtime PCR instrument with rectal swabs from patients at risk for VRE colonization. The IDI-VanR® Assay can be used as an aid to identify, prevent and control vancomycinresistant colonization in healthcare settings. Concomitant cultures are necessary to recover ofganisms for epidemiological typing, susceptibility testing and for further confirmatory identification. The IDI-VanR® Assay is not intended to diagnose VRE infections nor to guide or monitor treatment for VRE infections.
Following specimen lysis, amplification of the vanA and vanB targets occurs. Amplification of the IC, a DNA fragment of 294-bp including a 254-bp sequence not found in VRE, will also take place unless there are PCR inhibitory substances.
The amplified DNA targets are detected with molecular beacons, a hairpin-forming single-stranded oligonucleotides labelled at one end with a quencher and at the other end with a fluorescent reporter dye (fluorophore). In the absence of target, the fluorescence is quenched. In the presence of target, the hairpin structure opens upon beacon/target hybridization, resulting in emission of fluorescence. For the detection of vanA amplicons, the molecular beacon contains the fluorophore FAM at the 5' end and the non-fluorescent quencher moiety DABCYL at the opposite end of the oligonucleotide. For the detection of the vanB amplicons, the molecular beacon contains the fluorophore Texas Red at the 5' end and the quencher DABCYL at the 3' end. For the detection of the Internal Control (IC) amplicons, the molecular beacon contains the fluorophore TET at the 5' end and the quencher DABCYL at the 3' end. Each beacon-target hybrid fluoresces at a wavelength characteristic of the fluorophore used in the particular molecular beacon. The amount of fluorescence at any given cycle, or following cycling, depends on the amount of specific amplicons present at that time. The SmartCycler® software simultaneously monitors the fluorescence emitted by each beacon, interprets all data, and provides a final result at the end of the cycling program.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Rectal swabs
Indicated Patient Age Range
Not Found
Intended User / Care Setting
healthcare settings
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Four clinical trial sites evaluated the performance of the IDI-VanR™ Assay based on rectal swabs compared to culture technique. The sample size for the overall study was 968. Data source is clinical samples. Annotation protocol involves comparison with culture technique, including phenotypic identification of presumptive Enterococcus colonies and determination of vancomycin and teicoplanin resistance.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Clinical trial were performed at four sites to evaluate the performance of the IDI-VanR™ Assay to the Remel Bile Esculin Azide agar with 6 ug/mL vancomycin (BEAV) with phonotypic identification of presumptive Enterococcus colonies and determination of vancomycin and teicoplanin resistance. The overall study had a sample size of 968.
Key results:
Overall study:
Sensitivity: 97.3%
Specificity: 91.4%
Negative predictive value: 99.6%
Positive predictive value: 59.1%
Sensitivity VanA: 97.1% (91.6-99.4%)
Sensitivity VanB: 57.1% (1.8-90.1%)
The low sensitivity associated with vanB detection is due to the low number of vanB positive specimens.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Sensitivity VanA: 97.1% (91.6-99.4%)
Sensitivity VanB: 57.1% (1.8-90.1%)
Specificity: 91.4%
Overall Sensitivity: 97.3% (92.2%-99.4%)
Overall Specificity: 91.4% (89.3%-93.2%)
Negative Predictive Value: 99.6% (98.9%-99.9%)
Positive Predictive Value: 59.1% (51.6%-66.4%)
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 866.1640 Antimicrobial susceptibility test powder.
(a)
Identification. An antimicrobial susceptibility test powder is a device that consists of an antimicrobial drug powder packaged in vials in specified amounts and intended for use in clinical laboratories for determining in vitro susceptibility of bacterial pathogens to these therapeutic agents. Test results are used to determine the antimicrobial agent of choice in the treatment of bacterial diseases.(b)
Classification. Class II (performance standards).
0
K 061 t 86
AUG 8 9 2006
510(k) Summary
August 23, 2006
GeneOhm Sciences Canada, Inc. IDI-VanR™ Assay
| Submitted by: | GeneOhm Sciences Canada, Inc.
2050, boul. René-Lévesque O, 4º étage
Sainte-Foy, Québec
Canada
G1V 2K8 |
|------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact: | Patricia Dionne, Ph.D. |
| Name of Device:
Trade Name:
Common Name:
Classification Name: | IDI-VanR™ Assay
Vancomycin-resistant Enterococci detection assay
System, Nucleic Acid Amplification Test, DNA, Vancomycin
Resistant Bacteria, Direct Specimen |
| Predicate Device: | Remel Bile Esculin Azide agar with 6 ug/mL vancomycin
(BEAV) (K972359) |
Device Description:
Intended Use:
The IDI-VanR® Assay is a qualitative in vitro test for the rapid detection of vancomycinresistance (vanA and vanB) genes directly from rectal swabs. The IDI-vanR® Assav detects the presence of the vanA and vanB genes that can be associated with vancomycin-resistant enterococci (VRE). The assay is performed on an automated realtime PCR instrument with rectal swabs from patients at risk for VRE colonization. The IDI-VanR® Assay can be used as an aid to identify, prevent and control vancomycinresistant colonization in healthcare settings. Concomitant cultures are necessary to recover ofganisms for epidemiological typing, susceptibility testing and for further confirmatory identification. The IDI-VanR® Assay is not intended to diagnose VRE infections nor to guide or monitor treatment for VRE infections.
Test Description:
Following specimen lysis, amplification of the vanA and vanB targets occurs. Amplification of the IC, a DNA fragment of 294-bp including a 254-bp sequence not found in VRE, will also take place unless there are PCR inhibitory substances.
The amplified DNA targets are detected with molecular beacons, a hairpin-forming single-stranded oligonucleotides labelled at one end with a quencher and at the other end with a fluorescent reporter dye (fluorophore). In the absence of target, the fluorescence is quenched. In the presence of target, the hairpin structure opens upon beacon/target hybridization, resulting in emission of fluorescence. For the detection of vanA amplicons, the molecular beacon contains the fluorophore FAM at the 5' end and the non-fluorescent quencher moiety DABCYL at the opposite end of the oligonucleotide. For the detection of the vanB amplicons, the molecular beacon contains the fluorophore Texas Red at the 5' end and the quencher DABCYL at the 3' end. For the detection of the Internal Control (IC) amplicons, the molecular beacon contains the fluorophore TET
1
at the 5' end and the quencher DABCYL at the 3' end. Each beacon-target hybrid fluoresces at a wavelength characteristic of the fluorophore used in the particular molecular beacon. The amount of fluorescence at any given cycle, or following cycling, depends on the amount of specific amplicons present at that time. The SmartCycler® software simultaneously monitors the fluorescence emitted by each beacon, interprets all data, and provides a final result at the end of the cycling program.
Substantial Equivalence:
The GeneOhm Sciences Canada, Inc. IDI-VanR™ Assay has been found to be substantially equivalent to the Remel Bile Esculin Azide agar with 6 ug/mL vancomycin (BEAV) (K972359) with phenotypic identification of presumptive Enterococcus colonies (MMWR, 1995; CDC, 1999) and determination of vancomycin and teicoplanin resistance (CLSI, M7-A6 and M100-S15) for the detection of vancomycin resistance in presumptively identified cultures of Enterococcus faecalis and Enterococcus faecium.
Clinical trial were performed at four sites to evaluate the performance of the IDI-VanR™ Assay to the Remel Bile Esculin Azide agar with 6 ug/mL vancomvcin (BEAV) with phonotypic identification of presumptive Enterococcus colonies and determination of vancomycin and teicoplanin resistance. The results are summarized in Tables 1-3.
| IDI-VANRTM | |||||||
|---|---|---|---|---|---|---|---|
| VANA | VANB | VANA+B | NEGATIVE | UNRESOLVED | TOTAL | ||
| Culture | VanA | 80 | 0 | 18 | 3 | 0 | 101 |
| VanB | 0 | 4 | 3 | 0 | 0 | 7 | |
| VanA + B | 0 | 0 | 2 | 0 | 0 | 2 | |
| Negative | 14 | 58 | 2 | 783 | 1 | 858 | |
| Total : | 94 | 62 | 25 | 786 | 1 | 968 |
Table 1: Clinical Performance Obtained for vanA and van B with IDI-VanR™ Assay from Rectal Swabs for the Overall Study in Comparison with Culture Technique
Sensitivity VanA': 97.1% (91.6-99.4%) Sensitivity VanB: 57.1% (1.8-90.1%)
Specificity: 91.4%
Sensitivity VanB: 57.1% (1.8-90.1%)
The vanA+B PCR results and culture vanA positive were considered as true positive and included in the calculation of the sensitivity of vanA target.
The low sensitivity associated with vanB detection is due to the low number of vanB positive specimens.
2
| IDI-VANR TM | |||||
|---|---|---|---|---|---|
| POSITIVE | NEGATIVE | UNRESOLVED | TOTAL | ||
| Culture | Positive | 107 | 3 | 0 | 110 |
| Negative | 74 | 783 | 1 | 858 | |
| Total : | 181 | 786 | 1 | 968 |
Table 2: Clinical Performance Obtained with IDI-VanR™ Assay from Rectal Swabs for the Overall Study in Comparison with Culture Technique
Sensitivity: 97.3 (92.2%-99.4%)
Specificity: 91.4% (89.3%-93.2%)
3: Clinical Performance Obtained with IDI-VanR™ From Rectal Swabs by Each Table Investigational Site and For the Overall Study In Comparison With Culture Technique
| Site | Clinical sensitivity of
IDI-VanR™ | Clinical specificity IDI-
VanR™ (95% CI)A | Initial | After repeat
testing |
|---------------|--------------------------------------|----------------------------------------------|-----------------|-------------------------|
| Site #1 | 98.4%
(91.2%-100%) | 87.1%
(81.6%-91.5%) | 0.8%
(2/255) | 0.4%
(1/255) |
| Site #2 | 100%
(2.5-100%) | 87.3%
(81.3%-92.0%) | 0% | N/A |
| Site #3 | 100%
(2.5-100%) | 92.0%
(87.4%-95.4%) | 0% | N/A |
| Site #4 | 95.7%
(85.5%-99.5%) | 96.0%
(93.0%-97.9%) | 0% | N/A |
| Overall study | 97.3%
(92.2%-99.4%) | 91.4%
(89.3%-93.2%) | 0.2%
(2/968) | 0.1%
(1/968) |
A Binomial 95% confidence intervals
For the population tested, the negative predictive value was 99.6% (98.9%-99.9%) and the positive predictive value was 59.1% (51.6%-66.4%).
The low PPV is associated with vanB detection which is due to the low number of vanB positive specimens.
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services. The logo features a stylized eagle with three tail feathers. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES . USA" are arranged in a circular pattern around the eagle.
Public Health Service
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
AUG 3 0 2006
GeneOhm Sciences Canada, Inc. c/o Ms. Judi Smith Submission Correspondent Sienna Partners, LLC P.O. Box 103 Baldwin, Maryland 21082
K061686 Trade/Device Name: IDI-VanR® Assay Regulation Number: 21 CFR § 866.1640 Regulation Name: System test genotypic detection - resistant markers Regulatory Class: II Product Code: NIJ Dated: August 23, 2006 Received: August 24, 2006
Dear Ms. Smith:
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 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).
4
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 information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, 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). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.
Sincerely yours.
Sally, autry
Sally A. Hojvat, 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
5
Indications for Use
510(k) Number (if known): K061686
Device Name: IDI-VanR® Assay
Indications For Use:
The IDI-VanR® Assay is a qualitative in vitro test for the rapid detection of vancomycinresistance (vanA and vanB) genes directly from rectal swabs. The IDI-vanR® Assay detects the presence of the vanA and vanB genes that can be associated with vancomycin-resistant enterococci (VRE). The assay is performed on an automated realtime PCR instrument with rectal swabs from patients at risk for VRE colonization. The IDI-VanR® Assay can be used as an aid to identify, prevent and control vancomycinresistant colonization in healthcare settings. Concomitant cultures are necessary to recover organisms for epidemiological typing, susceptibility testing and for further confirmatory identification. The IDI-VanR® Assay is not intended to diagnose VRE infections nor to guide or monitor treatment for VRE infections.
Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Loddie My Poole
Division Sign-Off
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Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K061686