The Velogene™ Genomic Identification Assay for VRE (Vancomycin Resistant Enterococci) is an in vitro, DNA probe based, diagnostic device that utilizes Cycling Probe™ Technology (CPT) to generate a spectrophotometric or visual result. Results can be generated 90 minutes after primary isolation. The Velogene™ Genomic Identification Assay for VRE (hereafter may be referred to as the Velogene™ assay) utilizes a fluorescein labeled, biotinylated DNA-RNA-DNA chimeric probe providing an RNase H cleavable linkage when bound to the complementary sequence of the van A or vanB gene. RNase H cleaves the RNA portion of the chimeric probe when it is hybridized to the target DNA. The uncleaved probe (vanA and vanB negative) is detected by binding of the fluoresceinated probe to a solid surface and attachment of an antifluorescein antibody conjugated with horseradish peroxidase, which converts a substrate to a colored end product. Cleavage of the probe (vanA or vanB positive) prevents binding of the probe-anti-fluorescein antibody enzyme complex, thus preventing formation of the colored end product. A vancomycin-resistant isolate (i.e. vanA or vanB gene is present) will produce a colorless result (or OD650 of ≤0.14). A vancomycin-sensitive isolate (i.e. vanA and vanB gene are absent) will produce a distinctly blue color (or OD650 of >0.14). Each Velogene™ assay kit contains supplies sufficient to process 48 samples and consists of two separate reagent kits: a VRE Lysis/Cycle Kit and a VRE Microwell Detection Kit.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

The submission does not explicitly state pre-defined acceptance criteria (e.g., minimum sensitivity, specificity, or agreement metrics that needed to be met). Instead, it presents the results of a comparative study and implies that the observed agreement rate was sufficient for substantial equivalence.

Metric	Acceptance Criteria (Implied)	Reported Device Performance	Comments
Agreement with Predicate Device (Vancomycin Screen Agar)	Sufficient for Substantial Equivalence	94.6% agreement	This agreement rate was based on a comparative study. The submission implies that this level of agreement was acceptable for FDA clearance.

2. Sample Size Used for the Test Set and Data Provenance

Sample Size: 518 isolates
Data Provenance: The study was conducted at "3 geographically distributed U.S. sites" using "routinely submitted samples for microbiological identification." This indicates the data was prospective or at least collected in a routine clinical setting.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

The document does not specify the number of experts or their qualifications for establishing the ground truth. The ground truth was based on the predicate device, Vancomycin Screen Agar, which is a growth-based test. Interpretation of this test would typically be performed by trained laboratory personnel, but no specifics are given regarding expert review or reconciliation.

4. Adjudication Method for the Test Set

The document does not describe any specific adjudication method (e.g., 2+1, 3+1). The "ground truth" was established by the predicate device (Vancomycin Screen Agar), and the Velogene™ assay's results were compared against this. It's implied that the results of the Vancomycin Screen Agar were considered definitive for the purpose of this comparison.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not applicable and therefore not performed. This device is a standalone diagnostic assay (an in vitro DNA probe test) that provides a direct result (colorless or blue, or OD650 reading). It does not involve human readers interpreting images or data where AI assistance would improve human performance.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done

Yes, a standalone performance evaluation was done for the Velogene™ Genomic Identification Assay for VRE. The study compared the results of the Velogene™ assay (an "algorithm only" in the sense of a chemical/molecular assay without human interpretation of complex visuals) directly against the predicate device. The assay itself generates a direct spectrophotometric or visual result without human interpretation beyond reading the color or OD650 value.

7. The Type of Ground Truth Used

The ground truth used for the comparative study was the phenotypic result from a legally marketed predicate device: Vancomycin Screen Agar (Brain Heart Infusion (BHI) Agar with 6 ug/mL vancomycin). This is a growth-based test that identifies vancomycin resistance.

8. The Sample Size for the Training Set

The document does not provide information on a separate training set or its sample size. This type of submission (510(k)) for an IVD kit often focuses on clinical validation rather than a deep dive into the development and training of a machine learning model, which is not applicable here as it's a chemical assay. The comparison is the validation study.

9. How the Ground Truth for the Training Set Was Established

Since no separate training set is mentioned in the provided text, and the device is a molecular assay, the concept of establishing ground truth for a "training set" as it would apply to a machine learning algorithm is not relevant to this submission. The "ground truth" for the overall evaluation was the predicate device's results, against which the Velogene™ assay was compared.

Summary

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MAY 0 1 2002

510(K) SUMMARY

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92

Ko20576 The assigned 510(k) number is:

Submitter: ID Biomedical Corporation 1510 -- 800 West Pender Vancouver, British Columbia Canada V6C 2V6 Telephone: (604) 431-9314 Fax: (604) 431-93789 Establishment 3033040 Registration Number Contact Person: David N. Clary, Regulatory Affairs Associate ID Biomedical Corporation of Washington 19204 North Creek Parkwav Suite 100 Bothell, WA 98011 Telephone: (425) 482-2601, Ext. 424 Fax: (425) 482-2502 Date Prepared: February 20, 2002 Trade Name: Velogene™ Genomic Identification Assay for VRE Common Name: Manual genomic identity test II Device Class Classification Name: Manual antimicrobial susceptibility test system Special Controls No special controls have been issued for in vitro diagnostic devices under sections 513 and 514.

INTENDED USE

The Velogene™ Genomic Identification Assay for VRE is a qualitative DNA probe test which utilizes Cycling Probe™ Technology (CPT) to detect the vanA and vanB genes in isolated colonies of presumptively identified enterococci.

Confidential

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DEVICE DESCRIPTION

The Velogene™ Genomic Identification Assay for VRE (hereafter may be referred to as the Velogene™ assay) utilizes a fluorescein labeled, biotinylated DNA-RNA-DNA chimeric probe providing an RNase H cleavable linkage when bound to the complementary sequence of the van A or vanB gene. RNase H cleaves the RNA portion of the chimeric probe when it is hybridized to the target DNA. The uncleaved probe (vanA and vanB negative) is detected by binding of the fluoresceinated probe to a solid surface and attachment of an antifluorescein antibody conjugated with horseradish peroxidase, which converts a substrate to a colored end product. Cleavage of the probe (vanA or vanB positive) prevents binding of the probe-anti-fluorescein antibody enzyme complex, thus preventing formation of the colored end product. A vancomycin-resistant isolate (i.e. vanA or vanB gene is present) will produce a colorless result (or OD650 of ≤0.14). A vancomycin-sensitive isolate (i.e. vanA and vanB gene are absent) will produce a distinctly blue color (or OD650 of >0.14).

Each Velogene™ assay kit contains supplies sufficient to process 48 samples and consists of two separate reagent kits: a VRE Lysis/Cycle Kit and a VRE Microwell Detection Kit.

VRE Lysis/Cycle Kit

The Lysis/Cycle kit contains the reagents and components to:

Lyse sample cells from an overnight culture of presumptively identified enterococci .
Clarify the test solution .
Complete the Cycling Probe™ Technology (CPT) process .

VRE Microwell Detection Kit

The detection kit contains the reagents and components to:

Stop the CPT process ●
Bind the biotinylated end of both cleaved and uncleaved probes and remove the . fluorescein labeled end of cleaved probes
Complete the detection process .

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PREDICATE DEVICES

The predicate devices for ID Biomedical's Velogene™ Genomic Identification Assay for VRE kit are:

. Brain Heart Infusion (BHI) Agar with 6 ug/mL vancomycin, #K941444, Remel
. BHI Agar with 6 ug/mL vancomycin, #K964560, Hardy Diagnotics

Both are NCCLS approved tests for the detection of Vancomycin Resistant Enterococci (VRE).

SUMMARY OF SUBSTANTIAL EQUIVALENCE

Vancomvein Screen Agar

Vancomycin Screen Agar (BHI with 6 ug/mL Vancomycin) is a growth-based test that phenotypically identifies vancomycin resistance. Vancomycin screen agar is inoculated with a suspension of an overnight culture of enterococci and plates are examined for evidence of growth after a full 24 hours of incubation; growth indicates resistance to vancomycin.

Substantially equivalent characteristics:

Both tests require isolates to be gram-positive, catalase-negative; .
Both tests identify vancomycin resistance in enterococci due to the vanA or vanB . genes:
Vancomycin screen agar and the Velogene™ assay identify vancomycin-resistant . enterococci.

Substantially equivalent clinical performance:

A comparative study was performed at 3 geographically distributed U.S. sites using routinely submitted samples for microbiological identification. An agreement of 94.6% was obtained between the Velogene™ assay and the Vancomycin Screen Agar when 518 isolates of presumptively identified enterococci were tested (490/518).

ID Biomedical Corporation believes that the Velogene™ Genomic Identification Assay for VRE is substantially equivalent in characteristics and clinical performance to the currently marketed Vancomycin Screen Agar (BHI with 6 ug/mL Vancomycin) for the identification of vancomycin-resistant enterococci when applied in accordance with the intended use and proposed labeling.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the top half of the circle. Inside the circle is an abstract image of what appears to be an eagle.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

MAY 0-1 2002

Mr. David N. Clary Regulatory Affairs Associate ID Biomedical Corporation 19204 North Creek Parkway, Suite 100 Bothell, Washington 98011

K020576 Re:

Trade/Device Name: Velogene™ Genomic Identification Assay for VRE Regulation Number: 21 CFR 866.1640 Regulation Name: Antimicrobial Susceptibility Test System Regulatory Class: Class II Product Code: NIJ Dated: February 20, 2002 Received: February 21, 2002

Dear Mr. Clary:

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 the Code of Federal Regulations, Title 21, Parts 800 to 898. 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 Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 -

This letter will allow you to begin marketing your device as described in your 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 and 1 additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at additionally 607.10 1011-11-10 101 - 10-11-2017 on the promotion and advertising of your device, (2017 59 + 12 6 + 1 1 2 c = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 = 1 entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small monifacturers 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/cdrl/dsma/dsmamain.html".

Sincerely yours,

Steven Butman

Steven I. Gutman, M.D., M.B.A. Director Division of Clinical Laboratory Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Velogene™ Genomic Identification Assay for VRE

INDICATIONS FOR USE

Applicant: ID Biomedical Corporation, Vancouver, British Columbia, V6C 2V6 Canada

510(k) Number: K020576 .

Device Name: Velogene™ Genomic Identification Assay for VRE

Indications For Use:

For the visual or spectrophotometric detection of the vanA and vanB genes in determining vancomycin resistance in enterococci isolated from culture.

Freddie M. Poole

(Division Sign-Off) Division of Clinical Laboratory Devices

510(k) Number K020576

for Presc

scriptive Use

Confidential

Page 10 of 92

Regulation Number and Section

§ 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).