VITEK 2 AST-Gram Negative Cefazolin (<=1 - >=32 ug/mL)

K222073 · bioMerieux, Inc. · LON · Feb 9, 2023 · Microbiology

Device Facts

• Record ID: K222073
• Device Name: VITEK 2 AST-Gram Negative Cefazolin (<=1 - >=32 ug/mL)
• Applicant: bioMerieux, Inc.
• Product Code: LON · Microbiology
• Decision Date: Feb 9, 2023
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.1645
• Device Class: Class 2

Intended Use

VITEK® 2 AST-Gram Negative Cefazolin is designed for antimicrobial susceptibility testing of Gram negative bacilli 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 antimicrobial agents. VITEK® 2 AST-Gram Negative Cefazolin is a quantitative test. Cefazolin has been shown to be active against most strains of the microorganisms listed below, according to the FDA label for this antimicrobial. Active in vitro and in clinical infections: Escherichia coli Proteus mirabilis The VITEK® 2 Gram-Negative 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 aerobic Gram-negative bacilli to antimicrobial agents when used as instructed.

Device Story

VITEK® 2 AST-Gram Negative Cefazolin is a quantitative, automated in vitro diagnostic test for antimicrobial susceptibility. Input: bacterial isolate diluted in 0.45-0.5% saline. Operation: isolate rehydrates antimicrobial medium in 64-well AST card; VITEK® 2 system automatically fills, seals, and incubates card; system monitors growth in each well over time. Output: MIC value and interpretive category result. Used in clinical laboratories by technicians/microbiologists. Output assists healthcare providers in selecting appropriate antibiotic therapy for patients with Gram-negative infections. Benefits: standardized, automated susceptibility determination compared to manual microdilution.

Clinical Evidence

Performance evaluated using 463 isolates (387 clinical, 76 challenge) across three sites. Comparison against CLSI broth microdilution (BMD) reference method. For VITEK 2 auto-dilution, Essential Agreement (EA) was 97.4% and Category Agreement (CA) was 83.6% (with 15.6% minor errors, 1.3% major, 0.8% very major). Reproducibility testing (270 data points) showed 99.3-100% agreement within ±1 doubling dilution. Quality control using E. coli ATCC 25922 and 35218 met acceptance criteria (>95% within range). No trending observed.

Technological Characteristics

Automated microdilution MIC system. 64-well plastic test card containing premeasured antibiotic and culture media. Sensing principle: optical monitoring of bacterial growth over time. Connectivity: integrated with VITEK® 2 and VITEK® 2 Compact instrument platforms. Software: automated incubation and analysis.

Indications for Use

Indicated for antimicrobial susceptibility testing of clinically significant aerobic Gram-negative bacilli, specifically Escherichia coli and Proteus mirabilis, using the VITEK 2 and VITEK 2 Compact Systems.

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-GN Omadacycline (K213931)

Submission Summary (Full Text)

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February 9, 2023

bioMérieux, Inc. Kyle Olney Regulatory Affairs Specialist 595 Anglum Rd. Hazelwood, Missouri 63042

Re: K222073

Trade/Device Name: Vitek 2 AST Gram Negative Cefazolin (≤1 - ≥32 µg/mL) 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: July 12, 2022 Received: July 14, 2022

Dear Kyle Olney:

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 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

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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 (QS) 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 -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

Enclosure

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# Indications for Use

510(k) Number (if known) K222073

Device Name

VITEK® 2 AST-Gram Negative Cefazolin (≤1 - ≥32 µg/mL)

#### Indications for Use (Describe)

VITEK® 2 AST-Gram Negative Cefazolin is designed for antimicrobial susceptibility testing of Gram negative bacilli 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 antimicrobial agents. VITEK® 2 AST-Gram Negative Cefazolin is a quantitative test. Cefazolin has been shown to be active against most strains of the microorganisms listed below, according to the FDA label for this antimicrobial.

Active in vitro and in clinical infections: Escherichia coli Proteus mirabilis

The VITEK® 2 Gram-Negative 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 aerobic Gram-negative bacilli to antimicrobial agents when used as instructed.

Type of Use (Select one or both, as applicable)

| <span>☑ Prescription Use (Part 21 CFR 801 Subpart D)</span> |
|-------------------------------------------------------------|
| <span>☐ Over-The-Counter Use (21 CFR 801 Subpart C)</span> |

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## 510(k) SUMMARY

B.

C.

## VITEK® 2 AST-Gram Negative Cefazolin (≤1 - ≥32 µg/mL)

## 510(k) Submission Information:

| Submitter's Name: | bioMérieux, Inc. |
|----------------------|----------------------------------------------------------------------------------------------------------------------------|
| Address: | 595 Anglum Road<br>Hazelwood, MO 63042 |
| Contact Person: | Kyle Olney<br>Regulatory Affairs Specialist |
| Phone Number: | 314 -805-8642 |
| Fax Number: | 314-731-8689 |
| Date of Preparation: | June 24, 2022 |
| Device Name: | |
| Formal/Trade Name: | VITEK® 2 AST-Gram Negative Cefazolin (≤1 - ≥32<br>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-GN Ciprofloxacin (≤1 - ≥32 µg/mL) |
| Predicate Device: | VITEK® 2 AST-GN Omadacycline (≤0.25 - ≥16 µg/mL)<br>(K213931) |

## 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() and Gerlach(0). The VITEK® 2 AST card is essentially a miniaturized, abbreviated and automated version of the doubling dilution technique(3).

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Image /page/4/Picture/0 description: The image shows the logo for bioMérieux. The logo is a blue circle on top of a yellow-green circle. The word "BIOMÉRIEUX" is written in white letters inside the blue circle.

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 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-GN Cefazolin (≤1 - ≥32 µg/mL) has the following concentrations in the card: 1, 2, and 8 ug/mL (equivalent standard method concentration by efficacy in ug/mL).

## E. Substantial Equivalence Information:

The similarities and differences of the VITEK® 2 AST-GN Cefazolin (≤1 - ≥32 µg/mL) when compared to the predicate device, VITEK® 2 AST-GN Omadacycline (≤0.25 ->16 µg/mL), are described in the Table 1 below.

| Item | Device:<br>VITEK® 2 AST-Gram Negative<br>Cefazolin<br>(≤1 - ≥32 µg/mL) | Predicate:<br>VITEK® 2 AST-Gram Negative<br>Omadacycline (≤0.25 - ≥16 µg/mL)<br>(K213931) |
|--------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Similarities | | |
| Intended Use | VITEK® 2 AST-Gram Negative<br>Cefazolin is designed for<br>antimicrobial susceptibility testing of<br>Gram negative bacilli and is intended<br>for use with the VITEK® 2 and<br>VITEK® 2 Compact Systems as a<br>laboratory aid in the determination of<br><i>in vitro</i> susceptibility to<br>antimicrobial agents. VITEK® 2<br>AST-Gram Negative Cefazolin is a<br>quantitative test.<br><br>The VITEK® 2 Gram-Negative<br>Susceptibility Card is intended for<br>use with the VITEK® 2 Systems in<br>clinical laboratories as an <i>in vitro</i><br>test to determine the susceptibility of | VITEK® 2 AST-Gram Negative<br>Omadacycline is designed for<br>antimicrobial susceptibility testing<br>of Gram negative bacilli and is<br>intended for use with the VITEK®<br>2 and VITEK® 2 Compact Systems<br>as a laboratory aid in the<br>determination of <i>in vitro</i><br>susceptibility to antimicrobial<br>agents. VITEK® 2 AST-Gram<br>Negative Omadacycline is a<br>quantitative test.<br><br>The VITEK® 2 Gram-Negative<br>Susceptibility Card is intended for<br>use with the VITEK® 2 Systems in<br>clinical laboratories as an <i>in vitro</i> |

## Table 1: Substantial Equivalence

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| | clinically significant aerobic Gram<br>negative bacilli to antimicrobial<br>agents when used as instructed. | test to determine the susceptibility<br>of clinically significant aerobic<br>Gram negative bacilli to<br>antimicrobial agents when used as<br>instructed. |
|------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Test Methodology | Automated quantitative<br>antimicrobial susceptibility test for<br>use with the VITEK® 2 and VITEK®<br>2 Compact Systems to determine the<br><i>in vitro</i> susceptibility of<br>microorganisms | Same |
| Inoculum | Saline suspension of organism | Same |
| Test Card | Gram Negative (AST-GN)<br>Susceptibility Card | Same |
| Instrument | VITEK® 2 and VITEK® 2 Compact<br>Systems | Same |
| Type of Test | VITEK® 2 AST-Gram Negative<br>Cefazolin is a quantitative test. | Same |
| Differences | | |
| Antimicrobial<br>Agent | Cefazolin | Omadacycline |
| Concentrations | 1, 2, 8 | 0.5, 2, 8, 16 |
| Indications for use | Cefazolin has been shown to be<br>active against most strains of the<br>microorganisms listed below,<br>according to the FDA label for this<br>antimicrobial. | Omadacycline has been shown to<br>be active against most strains of<br>the microorganisms listed below,<br>according to the FDA label for this<br>antimicrobial. |
| | <b>Active <i>in vitro</i> and in clinical<br/>infections:</b><br><i>Escherichia coli</i><br><i>Proteus mirabilis</i> | <b>Active <i>in vitro</i> and in clinical<br/>infections:</b><br>For ABSSSI:<br><i>Enterobacter cloacae</i><br><i>Klebsiella pneumoniae</i><br>For CABP:<br><i>Klebsiella pneumoniae</i> |

## F. Intended Use:

VITEK® 2 AST-Gram Negative Cefazolin is designed for antimicrobial susceptibility testing of Gram negative bacilli 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 antimicrobial agents. VITEK® 2 AST-Gram Negative Cefazolin in is a quantitative test. Cefazolin has been shown to

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be active against most strains of the microorganisms listed below, according to the FDA label for this antimicrobial.

## Active in vitro and in clinical infections:

Gram-Negative Bacteria: Escherichia coli Proteus mirabilis

The VITEK® 2 Gram-Negative 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 aerobic Gram-negative bacilli to antimicrobial agents when used as instructed.

## G. Performance Overview and Conclusion:

VITEK® 2 AST-GN Cefazolin 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 (510[k]) presents data in support of VITEK® 2 AST-GN Cefazolin. 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-GN Cefazolin by comparing its performance with the CLSI broth microdilution reference method incubated at 16-24 hrs. The data is representative of performance on both the VITEK® 2 Compact instrument platforms.

The VITEK® 2 AST-GN Cefazolin demonstrated acceptable performance as presented in Table 2 below:

| Antimicrobial | Antimicrobial Code | Antibiotic Version | Bp1 | Comment2 | Essential Agreement<br>% Error | | | | Category Agreement<br>% Error | | | | % Reproducibility |
|---------------|--------------------|--------------------|---------------|----------------------------|--------------------------------|-----|-----|-----|-------------------------------|-----|-----|------|-------------------|
| | | | | | % EA | VME | ME | mE | % CA | VME | ME | mE | |
| Cefazolin | CZ | cz05n | CLSI<br>(FDA) | #, E<br>Enterobacteriaceae | 97.4 | N/A | N/A | N/A | 83.6 | 0.8 | 1.3 | 15.6 | 100 |

Table 2: VITEK® 2 AST-GN Cefazolin Performance

Reproducibility and Quality Control demonstrated acceptable results.

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## H. 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.