VITEK 2 AST-Yeast Fluconazole (<=0.5->=64 µg/mL), VITEK 2 AST-YS Fluconazole (<=0.5->=64 µg/mL), VITEK 2 AST-YS Fluconazole

K213241 · bioMerieux, Inc. · LON · Feb 25, 2022 · Microbiology

Device Facts

• Record ID: K213241
• Device Name: VITEK 2 AST-Yeast Fluconazole (<=0.5->=64 µg/mL), VITEK 2 AST-YS Fluconazole (<=0.5->=64 µg/mL), VITEK 2 AST-YS Fluconazole
• Applicant: bioMerieux, Inc.
• Product Code: LON · Microbiology
• Decision Date: Feb 25, 2022
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.1645
• Device Class: Class 2

Intended Use

VITEK® 2 AST-Yeast Fluconazole is designed for antifungal susceptibility testing of Candida species and is intended for use with the VITEK® 2 and VITEK® 2 Compact Systems as a laboratory aid in the determination of in vitro susceptibility to antifungal agents. VITEK® 2 AST-Yeast Fluconazole is a quantitative test. Fluconazole has been shown to be active against most strains of the microorganisms listed below, according to the FDA label for this antifungal. Active in vitro and in clinical infections: Candida albicans Candida parapsilosis Candida tropicalis The VITEK® 2 Fungal Susceptibility Card is intended for use with the VITEK® 2 Systems in clinical laboratories as an in vitro test to determine the susceptibility of clinically significant yeasts to antifungal agents when used as instructed.

Device Story

VITEK 2 AST-Yeast Fluconazole card performs automated quantitative antifungal susceptibility testing for Candida species. Input: yeast isolate diluted in saline. Operation: card contains 64 wells with premeasured fluconazole concentrations (2-64 µg/mL) and culture media; system automatically fills, seals, and incubates card; monitors growth via optical reader. Output: MIC value and interpretive category (S, I, R). Used in clinical laboratories by technicians. Healthcare providers use MIC results to guide antifungal therapy. Benefits: standardized, automated susceptibility determination compared to manual broth microdilution.

Clinical Evidence

Bench testing only. Performance evaluated using 367 clinical and 75 challenge isolates of C. albicans, C. parapsilosis, and C. tropicalis. Compared to CLSI broth microdilution reference method. Overall essential agreement (EA) was 96.2% and category agreement (CA) was 93.7%. Trending analysis showed a tendency toward higher MIC values compared to reference. Limitations added for C. parapsilosis (MIC 1-2 µg/mL) and resistant C. tropicalis results.

Technological Characteristics

Automated microdilution MIC technique. Card contains 64 wells with premeasured fluconazole (2, 4, 8, 16, 32, 64 µg/mL). Energy source: VITEK 2/Compact system incubator/reader. Connectivity: Integrated with VITEK 2 system software. Software algorithm: Discriminant Analysis. Sterilization: Not specified.

Indications for Use

Indicated for antifungal susceptibility testing of Candida albicans, Candida parapsilosis, and Candida tropicalis in clinical laboratories using VITEK 2 or VITEK 2 Compact systems. Contraindicated for reporting results without alternative testing for C. glabrata, C. parapsilosis (MIC 1-2 µg/mL), and resistant C. tropicalis results.

Regulatory Classification

Identification

A fully automated short-term incubation cycle antimicrobial susceptibility system is a device that incorporates concentrations of antimicrobial agents into a system for the purpose of determining in vitro susceptibility of bacterial pathogens isolated from clinical specimens. Test results obtained from short-term (less than 16 hours) incubation are used to determine the antimicrobial agent of choice to treat bacterial diseases.

Special Controls

*Classification.* Class II (special controls). The special control for this device is FDA's guidance document entitled “Class II Special Controls Guidance Document: Antimicrobial Susceptibility Test (AST) Systems; Guidance for Industry and FDA.”

Predicate Devices

• Vitek 2 Ast - Yeast Fluconazole (K133817)

Submission Summary (Full Text)

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left, there is a symbol representing the Department of Health & Human Services - USA. To the right of this symbol, there is the FDA logo in blue, with the words "U.S. FOOD & DRUG" above the word "ADMINISTRATION".

February 25, 2022

BioMerieux, Inc. Esther Hernandez Regulatory Affairs Specialist 595 Anglum Road Hazelwood, Missouri 63042

## Re: K213241

Trade/Device Name: VITEK 2 AST-Yeast Fluconazole (<=0.5->=64 ug/mL), VITEK 2 AST-YS Fluconazole (<= 0.5->=64 ug/mL), VITEK 2 AST-YS Fluconazole Regulation Number: 21 CFR 866.1645 Regulation Name: Fully Automated Short-Term Incubation Cycle Antimicrobial Susceptibility System Regulatory Class: Class II Product Code: LON Dated: September 29, 2021 Received: September 30, 2021

Dear Esther Hernandez:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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

{1}------------------------------------------------

requirements, including, but not limited to: registration and listing (21 CFR Part 801 and Part 809); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

Ribhi Shawar, Ph.D. (ABMM) Chief General Bacteriology and Antimicrobial Susceptibility Branch Division of Microbiology Devices OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Ouality Center for Devices and Radiological Health

Enclosure

{2}------------------------------------------------

# Indications for Use

510(k) Number (if known)

#### K213241

Device Name

VITEK® 2 AST-Yeast Fluconazole (≤0.5 - ≥64 ug/mL)

#### Indications for Use (Describe)

VITEK® 2 AST-Yeast Fluconazole is designed for antifungal susceptibility testing of Candida species and is intended for use with the VITEK® 2 and VITEK® 2 Compact Systems as a laboratory aid in the determination of in vitro susceptibility to antifungal agents. VITEK® 2 AST-Yeast Fluconazole is a quantitative test. Fluconazole has been shown to be active against most strains of the microorganisms listed below, according to the FDA label for this antifungal.

Active in vitro and in clinical infections: Candida albicans Candida parapsilosis Candida tropicalis

The VITEK® 2 Fungal Susceptibility Card is intended for use with the VITEK® 2 Systems in clinical laboratories as an in vitro test to determine the susceptibility of clinically significant yeasts to antifungal agents when used as instructed.

| Type of Use (Select one or both, as applicable) | |
|----------------------------------------------------------------------------------|--------------------------------------------------------------------------------|
| <div> <span> Prescription Use (Part 21 CFR 801 Subpart D) </span> </div> | <div> <span> Over-The-Counter Use (21 CFR 801 Subpart C) </span> </div> |

### CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995,

### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

> Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff [e-mail]

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{3}------------------------------------------------

## 510(k) SUMMARY

### VITEK® 2 AST-YS Fluconazole

### A. 510(k) Submission Information:

| Submitter's Name: | bioMérieux, Inc. |
|----------------------|---------------------------------------------------------------------------------------------------------------------------|
| Address: | 595 Anglum Road<br>Hazelwood, MO 63042 |
| Contact Person: | Esther Hernandez<br>Regulatory Affairs Specialist |
| Phone Number: | 314-731-8841 |
| Fax Number: | 314-731-8689 |
| Date of Preparation: | September 29, 2021 |
| B. Device Name: | |
| Formal/Trade Name: | VITEK® 2 AST-Yeast Fluconazole (≤ 0.5 – ≥64 µg/mL) |
| Classification Name: | 21 CFR 866.1645<br>Fully Automated Short-Term Incubation Cycle<br>Antimicrobial Susceptibility System<br>Product Code LON |
| Common Name: | VITEK® 2 AST-YS Fluconazole |
| C. Predicate Device: | VITEK® 2 AST-Yeast Fluconazole (K133817) |

### D. Device Description:

The principle of the VITEK® 2 AST cards is based on the microdilution minimum inhibitory concentration (MIC) technique reported by MacLowry and Marsh (1) and Gerlach (2). The VITEK® 2 AST card is essentially a miniaturized, abbreviated and automated version of the doubling dilution technique (3).

Each VITEK® 2 AST card contains 64 wells. A control well which only contains microbiological culture media is resident on all cards. The remaining wells contain premeasured portions of a specific antibiotic combined with culture media. The bacterial or yeast isolate to be tested is diluted to a standardized concentration with 0.45 - 0.5% saline before being used to rehydrate the antimicrobial medium within the card. The VITEK® 2

{4}------------------------------------------------

System automatically fills, seals and places the card into the incubator/reader. The VITEK® 2 Compact has a manual filling, sealing and loading operation. The VITEK® 2 Systems monitor the growth of each well in the card over a defined period of time. At the completion of the incubation cycle, a report is generated that contains the MIC value along with the interpretive category result for each antibiotic contained on the card.

VITEK® 2 AST-YS Fluconazole has the following concentrations in the card: 2, 4, 8, 16, 32, and 64 (equivalent standard method concentration by efficacy in us/mL).

## E. Substantial Equivalence Information

The similarities and differences of the VITEK 2 AST-YS Fluconazole when compared to the predicate device, VITEK 2 AST-YS Fluconazole (K133817), are described in the following table. The only difference between both devices are the Indications for Use and the breakpoints used to analyze the data performance. The below table provides the similarities and differences:

| Item | Device:<br>VITEK® 2 AST-YS Fluconazole | Predicate:<br>VITEK® 2 AST-GN Fluconazole<br>(K133817) |
|--------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | VITEK® 2 AST-Yeast Fluconazole<br>is designed for antifungal<br>susceptibility testing of Candida<br>species and is intended for use with<br>the VITEK® 2 and VITEK® 2<br>Compact Systems as a laboratory aid<br>in the determination of in vitro<br>susceptibility to antifungal agents.<br>VITEK® 2 AST-Yeast Fluconazole<br>is a quantitative test. Fluconazole<br>has been shown to be active against<br>most strains of the microorganisms<br>listed below, according to the FDA<br>label for this antifungal.<br><br>Active in vitro and in clinical<br>infections:<br><i>Candida albicans</i><br><i>Candida parapsilosis</i><br><i>Candida tropicalis</i><br><br>The VITEK® 2 Fungal Susceptibility<br>Card is intended for use with the<br>VITEK® 2 Systems in clinical<br>laboratories as an in vitro test to<br>determine the susceptibility of | VITEK® 2 AST-Yeast Fluconazole is<br>designed for antifungal susceptibility<br>testing of Candida species and is a<br>quantitative test intended for use with<br>the VITEK® 2 and VITEK® 2<br>Compact Systems as a laboratory aid<br>in the determination of in vitro<br>susceptibility to antifungal agents.<br>VITEK® 2 AST-Yeast Fluconazole<br>has been shown to be active against<br>most strains of the microorganisms<br>listed below, according to the FDA<br>label for this antifungal.<br><br>Active in vitro and in clinical<br>infections:<br><i>Candida albicans</i><br><i>Candida parapsilosis</i><br><i>Candida tropicalis</i><br><br>The following in vitro data are<br>available, but their clinical<br>significance is unknown:<br><i>Candida dubliniensis</i><br><i>Candida guilliermondii</i><br><i>Candida lusitaniae</i> |

{5}------------------------------------------------

| | clinically significant yeasts to<br>antifungal agents when used as<br>instructed. | The VITEK® 2 Antimicrobial<br>Susceptibility Test (AST) is intended to<br>for use with the VITEK 2 Systems for<br>the automated quantitative or qualitative<br>susceptibility testing of isolated colonies<br>for most clinically significant aerobic<br>Gram-negative bacilli, Staphylococcus<br>spp., Enterococcus spp., Streptococcus<br>spp. and clinical significant yeast. |
|---------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Test Methodology | Automated quantitative antimicrobial<br>susceptibility test for use with the<br>VITEK® 2 and VITEK® 2 Compact<br>Systems to determine the in vitro<br>susceptibility of yeast. | Same |
| Antimicrobial Agent | Fluconazole | Same |
| Inoculum | Saline suspension of organism | Same |
| Test Card | VITEK® 2 Yeast (AST) Susceptibility<br>Test Card | Same |
| Analysis Algorithms | Discriminant Analysis | Same |
| Instrument | VITEK® 2 and VITEK® 2 Compact<br>Systems | Same |
| Concentrations | 2, 4, 8, 16, 32, 64 | Same |
| | Differences | |
| Indications for Use | Candida albicans<br>Candida parapsilosis<br>Candida tropicalis | Candida albicans<br>Candida parapsilosis<br>Candida tropicalis<br>Candida dubliniensis<br>Candida guilliermondii<br>Candida lusitaniae |
| Breakpoints for Candida<br>spp. | Candida albicans: ≤2 (S), 4 (I), ≥8 (R)<br>Candida parapsilosis: ≤2 (S), 4 (I),<br>≥8 (R)<br>Candida tropicalis: ≤2 (S), 4 (I), ≥8<br>(R) | Candida spp.: ≤8 (S), 16-32 (I), ≥64<br>(R) |

## F. Intended Use:

VITEK® 2 AST-Yeast Fluconazole is designed for antifungal susceptibility testing of Candida species and is intended for use with the VITEK® 2 and VITEK® 2 Compact Systems as a laboratory aid in the determination of in vitro susceptibility to antifiungal agents. VITEK® 2 AST-Yeast Fluconazole is a quantitative test. Fluconazole has been shown to be active against most strains of the microorganisms listed below, according to the FDA label for this antifungal.

Active in vitro and in clinical infections:

{6}------------------------------------------------

Image /page/6/Picture/0 description: The image shows the logo for bioMerieux. The logo consists of a stylized circular graphic with vertical lines on the left half and a curved line extending from the right side. Below the graphic, the word "BIOMERIEUX" is written in a sans-serif font, with the letters evenly spaced.

Candida albicans Candida parapsilosis Candida tropicalis

The VITEK® 2 Fungal Susceptibility Card is intended for use with the VITEK® 2 Systems in clinical laboratories as an in vitro test to determine the susceptibility of clinicant veasts to antifungal agents when used as instructed.

## G. Performance Overview:

VITEK® 2 AST-YS Fluconazole demonstrated substantially equivalent performance when compared with the CLSI broth microdilution reference method, as defined in the FDA Class II Special Controls Guidance Document: Antimicrobial Susceptibility Test (AST) Systems; Guidance for Industry and FDA (Issued August 28, 2009).

The Premarket Notification (Special 510[k]) presents data in support of VITEK® 2 AST-YS Fluconazole. An external evaluation was conducted with fresh and stock clinical isolates, as well as a set of challenge strains. The external evaluations were designed to confirm the acceptability of VITEK® 2 AST-YS Fluconazole by comparing its performance with the CLSI broth microdilution reference method incubated at 24 hours (or up to 48 hours for isolates that are not growing well at 24 hours). The data is representative of performance on both the VITEK® 2 and VITEK® 2 Compact instrument platforms.

VITEK® 2 AST-YS Fluconazole demonstrated acceptable performance of 96.2% overall Essential Agreement and 93.7% overall Category Agreement with the reference method when testing C. albicans. C. parapsilosis, and C. tropicalis.

| Antimicrobial | Anti-<br>microbial<br>Code | Antibiotic<br>Version | Bp1 | Comment | Essential Agreement | | | | Category Agreement | | | | %Repro-<br>ducibility |
|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------|-----------------------|---------------|---------|---------------------|-----|-----|-----|--------------------|---------------|-----------------|-----------------|-----------------------|
| | | | | | % EA | VME | ME | mE | % CA | VME | ME | mE | |
| Fluconazole | FLU | flu02n | CLSI<br>(FDA) | #, E, | (425/442)<br>96.2 | N/A | N/A | N/A | (414/442)<br>93.7 | (2/26)<br>7.7 | (12/398)<br>3.0 | (14/442)<br>3.2 | 100 |
| An overall essential agreement rate of 99.1% and an overall category<br>agreement rate of 94.5% were observed for Candida parapsilosis when<br>tested with VITEK 2 Fluconazole. Compared to the reference broth<br>microdilution, two of 14 results for Candida parapsilosis (one of which<br>was in essential agreement) resulted in very major errors.<br><br>VITEK 2 Fluconazole MIC values tended to be in exact agreement or at<br>least one doubling dilution higher when testing C. albicans, C<br>parapsilosis, and C. tropicalis compared to the broth microdilution<br>reference method. | | | | | | | | | | | | | |

{7}------------------------------------------------

Abbreviations - Bo = breakpoint committee; EA = essential agreement; VME = Very Major Error(susceptbleresult withesistantreferenceresult; ME Major Enror (resistant with succeptible reference result); mE = minor (susceptible or resistant result, or an intermediate result, or an internediate result, or an internedia with a susceptible or resistant reference result) # = US Food and Drug Administration 510(k) cleared CLSI = Clinical and Laboratory Standards Institute E = External performance data N/A = Not applicable

Reproducibility and Quality Control demonstrated acceptable results.

### H. Conclusion:

The performance data presented in this submission support a substantial equivalence decision. VITEK® 2 AST-Yeast Fluconazole (≤ 0.5 –>64 µg/mL) is substantially equivalent to VITEK® 2 AST-Yeast Fluconazole (K133817).

### References:

- 1. MacLowry, J.D. and Marsh, H.H., Semi-automatic Microtechnique for Serial Dilution Antibiotic Sensitivity Testing in the Clinical laboratory, Journal of Laboratory Clinical Medicine, 72:685-687, 1968.
- 2. Gerlach, E.H., Microdilution 1: A Comparative Study, p. 63-76. Current Techniques for Antibiotic Susceptibility Testing. A. Balows (ed.), Charles C. Thomas, Springfield, IL, 1974.
- 3. Barry, A.L., The Antimicrobic Susceptibility Test, Principles and Practices, Lea and Febiger, Philadelphia, PA, 1976.