VITEK 2 AST-Yeast Anidulafungin (<= 0.015 - >= 8 µg/mL)

K232963 · bioMerieux, Inc. · NGZ · Jun 7, 2024 · Microbiology

Device Facts

• Record ID: K232963
• Device Name: VITEK 2 AST-Yeast Anidulafungin (<= 0.015 - >= 8 µg/mL)
• Applicant: bioMerieux, Inc.
• Product Code: NGZ · Microbiology
• Decision Date: Jun 7, 2024
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.1640
• Device Class: Class 2
• Attributes: AI/ML

Intended Use

VITEK® 2 AST-Yeast Anidulafungin is designed for antifungal susceptibility testing of Candida species and is intended for use with the VITEK® 2 Systems as a laboratory aid in the determination of in vitro susceptibility to antifungal agents. VITEK 2 AST-Yeast Anidulafungin is a quantitative test. Anidulafungin 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 glabrata Candida parapsilosis Candida tropicalis In vitro data are available, but clinical significance is unknown: Candida guilliermondii Candida krusei 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 Anidulafungin is an automated, quantitative antifungal susceptibility test card for use with VITEK 2 and VITEK 2 Compact systems. The device uses a miniaturized, automated version of the broth dilution technique. Input: saline-diluted yeast isolate suspension. Operation: system fills, seals, and incubates the 64-well card; optical scanner measures light attenuation every 15 minutes to monitor growth. Output: MIC values and interpretive category results (S/I/R) generated via software report. Used in clinical laboratories by technicians/microbiologists. Results assist clinicians in selecting appropriate antifungal therapy. Benefits: standardized, automated susceptibility testing for Candida species.

Clinical Evidence

Performance evaluated via external study comparing VITEK 2 AST-YS Anidulafungin to CLSI broth microdilution reference method. Study used fresh and stock clinical isolates plus challenge strains. Results showed high essential agreement (EA) across Candida species (range 90.5%–100%) and category agreement (CA) (range 86.1%–100%). Reproducibility was 98.15%. One very major error (VME) was observed for C. tropicalis (33.3%).

Technological Characteristics

Miniaturized 64-well test card containing premeasured anidulafungin concentrations (0.0625–8 µg/mL). Sensing principle: growth-based detection via visible light transmittance optics. System: VITEK 2/VITEK 2 Compact. Connectivity: networked system. Software: VITEK 2 Systems 9.04 or later. Algorithm: Discriminant Analysis.

Indications for Use

Indicated for antifungal susceptibility testing of Candida species (C. albicans, C. glabrata, C. parapsilosis, C. tropicalis, C. guilliermondii, C. krusei) using VITEK 2 and VITEK 2 Compact systems. Prescription use only.

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

• VITEK® 2 AST-Yeast Caspofungin (K213899)

Submission Summary (Full Text)

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June 7, 2024

bioMérieux, Inc. Esther Hernandez Regulatory Specialist 595 Anglum Rd. Hazelwood, Missouri 63042

Re: K232963

Trade/Device Name: VITEK 2 AST-Yeast Anidulafungin (< 0.015 -> 8 us/mL) Regulation Number: 21 CFR 866.1640 Regulation Name: Antimicrobial Susceptibility Test Powder Regulatory Class: Class II Product Code: NGZ, LTT, LTW, LRG, LON Dated: September 21, 2023 Received: September 21, 2023

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 (the 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 available at https://www.accessdata.fda.gov/scripts/cdrb/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.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

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Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 and Part 809); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safetyreporting-combination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 -S

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

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# Indications for Use

510(k) Number (if known) K232963

Device Name VITEK 2 AST-Yeast Anidulafungin (< 0.015 - > 8 ug/mL)

#### Indications for Use (Describe)

VITEK 2 AST-Yeast Anidulafungin 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 Anidulafungin is a quantitative test. Anidulafungin 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 glabrata Candida parapsilosis Candida tropicalis

In vitro data are available, but clinical significance is unknown: Candida guillermondii Candida krusei

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 yeasts to antifungal agents when used as instructed.

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

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## 510(k) SUMMARY

### VITEK® 2 AST-YS Anidulafungin

#### 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: | 02 May, 2024 |
| B. Device Name: | Formal/Trade Name: | VITEK® 2 AST-Yeast Anidulafungin (≤ 0.015 – ≥8 $ \mu $ g/mL) |
| | Classification Name: | 21 CFR 866.1640<br>Antimicrobial susceptibility test powder<br>Product Code NGZ, LRG, LTT, LTW, LON |
| | Common Name: | VITEK® 2 AST-YS Anidulafungin |
| C. Predicate Device: | VITEK® 2 AST-Yeast Caspofungin (K213899) | |

### 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 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

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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 Anidulafungin has the following concentrations in the card: 0.0625, 0.125, 0.5, 2, and 8 (equivalent standard method concentration by efficacy in ug/mL).

## E. Substantial Equivalence Information

The similarities and differences of the VITEK 2 AST-YS Anidulafungin when compared to the predicate device, VITEK 2 AST-YS Caspofungin (K213899), 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 Anidulafungin<br>(K232963) | Predicate:<br>VITEK® 2 AST-YS Caspofungin<br>(K213899) |
|-----------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Similarities | | |
| Intended<br>Use | VITEK 2 AST-Yeast Anidulafungin<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 Compact<br>Systems as a laboratory aid in the<br>determination of in vitro<br>susceptibility to antifungal agents.<br>VITEK 2 AST-Yeast Anidulafungin<br>is a quantitative test. Anidulafungin<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>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<br>clinically significant yeasts to<br>antifungal agents when used as<br>instructed. | VITEK 2 AST-Yeast Caspofungin is<br>designed for antifungal susceptibility<br>testing of Candida species and is<br>intended for use with the VITEK 2 and<br>VITEK 2 Compact Systems as a<br>laboratory aid in the determination of in<br>vitro susceptibility to antifungal agents.<br>VITEK 2 AST-Yeast Caspofungin is a<br>quantitative test. Caspofungin has been<br>shown to be active against most strains<br>of the microorganisms listed below,<br>according to the FDA label for this<br>antifungal.<br><br>The VITEK 2 Fungal Susceptibility<br>Card is intended for use with the VITEK<br>2 Systems in clinical laboratories as an<br>in vitro test to determine the<br>susceptibility of clinically significant<br>yeasts to antifungal agents when used as<br>instructed. |

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| Test<br>Methodology | Automated quantitative antimicrobial<br>susceptibility test for use with the<br>VITEK 2 and VITEK 2 Compact<br>Systems to determine the <i>in vitro</i><br>susceptibility of yeast. | Automated quantitative antimicrobial<br>susceptibility test for use with the VITEK<br>2 and VITEK 2 Compact Systems to<br>determine the <i>in vitro</i> susceptibility of<br>yeast. |
|---------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Inoculum | Saline suspension of organism | Saline suspension of organism |
| Test Card | VITEK 2 Yeast Susceptibility Test Card | VITEK 2 Yeast Susceptibility Test Card |
| Instrument | VITEK 2 and VITEK 2 Compact<br>Systems | VITEK 2 and VITEK 2 Compact Systems |
| Analysis<br>Algorithms | Discriminant Analysis | Discriminant Analysis |
| Differences | | |
| Antifungal<br>Agent | Anidulafungin | Caspofungin |
| Antimicrobial<br>Concentrations | 0.0625, 0.125, 0.5, 2, 8 | 0.125, 0.5, 2, 8 |
| Claimed<br>Species | <i>Active in vitro</i> and in clinical<br>infections:<br>Candida albicans<br>Candida glabrata<br>Candida parapsilosis<br>Candida tropicalis<br><br><i>In vitro</i> data are available, but clinical<br>significance is unknown:<br>Candida guilliermondii<br>Candida krusei | <i>Active in vitro</i> and in clinical infections:<br>Candida albicans<br>Candida guilliermondii<br>Candida krusei<br>Candida parapsilosis<br>Candida tropicalis |

## F. Intended Use:

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VITEK® 2 AST-Yeast Anidulafungin is designed for antifungal susceptibility testing of Candida species and is intended for use with the VITEK® 2 Systems as a laboratory aid in the determination of in vitro susceptibility to antifungal agents. VITEK 2 AST-Yeast Anidulafungin is a quantitative test. Anidulafungin 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 glabrata Candida parapsilosis Candida tropicalis

In vitro data are available, but clinical significance is unknown: Candida guilliermondii Candida krusei

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.

## G. Performance Overview:

VITEK® 2 AST-YS Anidulafungin 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 (Traditional 510[k]) presents data in support of VITEK® 2 AST-YS Anidulafungin. 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 Anidulafungin by comparing its performance with the CLSI broth microdilution reference method incubated for 24 hours for isolates that are not growing well). The data is representative of performance on both the VITEK® 2 and VITEK® 2 Compact instrument platforms.

VITEK® 2 AST-YS Anidulafungin demonstrated acceptable performance as presented in the table below.

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| Antimicrobial | Antimicrobial Code | Antibiotic Version | Bp1 | Comment | Essential Agreement | | | Category Agreement | | | | % Reproducibility | |
|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------|--------------------|------------|---------------------------|---------------------|-----|-----|--------------------|-------------------|----------------|----------------|-------------------------------|-------|
| | | | | | % EA | VME | ME | mE | % CA | VME | ME | mE | |
| Anidulafungin | ANI | ani01n | CLSI (FDA) | #, E<br>C. albicans | (206/206)<br>100 | N/A | N/A | N/A | (206/206)<br>100 | (0/0)<br>0.0 | (0/206)<br>0.0 | (0/206)<br>0.0 | 98.15 |
| | | | | #, E<br>C. glabrata | (113/116)<br>97.4 | N/A | N/A | N/A | (114/116)<br>98.3 | (0/4)<br>0.0 | (1/111)<br>0.9 | (1/116)<br>0.9 | |
| | | | | #, E<br>C. guilliermondii | (19/21)<br>90.5 | N/A | N/A | N/A | (19/21)<br>90.5 | (0/0)<br>0.0 | (0/20)<br>0.0 | (2/21)<br>9.5 | |
| | | | | #, E<br>C. krusei | (68/69)<br>98.6 | N/A | N/A | N/A | (69/69)<br>100 | (0/0)<br>0.0 | (0/69)<br>0.0 | (0/69)<br>0.0 | |
| | | | | #, E<br>C. parapsilosis | (72/72)<br>100 | N/A | N/A | N/A | (62/72)<br>86.1 | (0/0)<br>0.0 | (1/62)<br>1.6 | (9/72)<br>12.5 | |
| | | | | #, E<br>C. tropicalis | (79/81)<br>97.5 | N/A | N/A | N/A | (78/81)<br>96.3 | (1/3)<br>33.3* | (0/77)<br>0.0 | (2/81)<br>2.5 | |
| VITEK® 2 Anidulafungin MIC values for <i>C. albicans</i> tended to be in<br>exact agreement or at least one doubling dilution lower than the<br>reference MIC values. Anidulafungin MIC values for <i>C. glabrata</i> and<br><i>C. krusei</i> tended to be in exact agreement or at least one doubling<br>dilution higher than the reference MIC values.<br>*When evaluating VITEK 2 AST-YS Anidulafungin, there was a<br>single very major error (VMJ) that resulted in an unacceptable VMJ<br>rate of 33.3% (1/3) with <i>C. tropicalis</i> . | | | | | | | | | | | | | |

1 Abbreviations - Bp = breakpoint committee; EA = essential agreement; CA = category agreement; VME = Very Major Error (susceptible result with resistant reference result); ME Major Error (resistant result with susceptible reference result); mE = minor Error (susceptible or resistant result with an intermediate reference result, or an intermediate result with a susceptible or resistant reference result).

# = US Food and Drug Administration 510(k) cleared

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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-YS Anidulafungin (≤0.015 –>8 µg/mL) is substantially equivalent to VITEK® 2 AST-YS Caspofungin (K213899).

#### 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.