IDI-VANR ASSAY

K061686 · Geneohm Sciences Canada, Inc. · NIJ · Aug 30, 2006 · Microbiology

Device Facts

• Record ID: K061686
• Device Name: IDI-VANR ASSAY
• Applicant: Geneohm Sciences Canada, Inc.
• Product Code: NIJ · Microbiology
• Decision Date: Aug 30, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.1640
• Device Class: Class 2

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.

Device Story

The IDI-VanR Assay is an in vitro diagnostic test for detecting vanA and vanB genes in rectal swabs. Input consists of rectal swab specimens; processing involves specimen lysis followed by real-time PCR amplification of target genes and an internal control. Detection utilizes molecular beacons—hairpin-forming oligonucleotides labeled with fluorophores (FAM for vanA, Texas Red for vanB, TET for internal control) and a DABCYL quencher. In the presence of target DNA, hybridization opens the beacon, emitting fluorescence. The SmartCycler instrument monitors fluorescence in real-time; software interprets data to provide results. Used in healthcare settings to aid in VRE colonization control; requires concomitant cultures for confirmation and susceptibility testing. Results assist clinicians in identifying colonized patients for infection control measures.

Clinical Evidence

Clinical trial at four sites (n=968) compared IDI-VanR Assay to culture-based phenotypic identification. Overall sensitivity for vanA was 97.1% and vanB was 57.1% (low sensitivity due to low prevalence of vanB). Overall sensitivity for VRE detection was 97.3% (95% CI: 92.2%-99.4%) and specificity was 91.4% (95% CI: 89.3%-93.2%). Negative predictive value was 99.6%; positive predictive value was 59.1%.

Technological Characteristics

Real-time PCR assay using molecular beacon technology. Targets: vanA, vanB, and internal control DNA. Detection via fluorophore-quencher labeled oligonucleotides (FAM, Texas Red, TET). Instrument: SmartCycler. Qualitative in vitro diagnostic test.

Indications for Use

Indicated for qualitative detection of vanA and vanB genes associated with VRE in rectal swabs from patients at risk for VRE colonization. Not for diagnosing VRE infections or monitoring treatment.

Regulatory Classification

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.

Predicate Devices

• Remel Bile Esculin Azide agar with 6 ug/mL vancomycin (BEAV) (K972359)

Submission Summary (Full Text)

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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.<br>2050, boul. René-Lévesque O, 4º étage<br>Sainte-Foy, Québec<br>Canada<br>G1V 2K8 |
|------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact: | Patricia Dionne, Ph.D. |
| Name of Device:<br>Trade Name:<br>Common Name:<br>Classification Name: | IDI-VanR™ Assay<br>Vancomycin-resistant Enterococci detection assay<br>System, Nucleic Acid Amplification Test, DNA, Vancomycin<br>Resistant Bacteria, Direct Specimen |
| Predicate Device: | Remel Bile Esculin Azide agar with 6 ug/mL vancomycin<br>(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

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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.

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| | | 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<br>IDI-VanR™ | Clinical specificity IDI-<br>VanR™ (95% CI)A | Initial | After repeat<br>testing |
|---------------|--------------------------------------|----------------------------------------------|-----------------|-------------------------|
| Site #1 | 98.4%<br>(91.2%-100%) | 87.1%<br>(81.6%-91.5%) | 0.8%<br>(2/255) | 0.4%<br>(1/255) |
| Site #2 | 100%<br>(2.5-100%) | 87.3%<br>(81.3%-92.0%) | 0% | N/A |
| Site #3 | 100%<br>(2.5-100%) | 92.0%<br>(87.4%-95.4%) | 0% | N/A |
| Site #4 | 95.7%<br>(85.5%-99.5%) | 96.0%<br>(93.0%-97.9%) | 0% | N/A |
| Overall study | 97.3%<br>(92.2%-99.4%) | 91.4%<br>(89.3%-93.2%) | 0.2%<br>(2/968) | 0.1%<br>(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.

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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).

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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 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 [phone]. 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 [phone] or [phone] 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

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### 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

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Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) K061686