VITEK 2 AST-Gram Negative Ceftazidime (=<0.5 - =>32 µg/mL)

K193299 · bioMerieux, Inc. · LON · Sep 28, 2020 · Microbiology

Device Facts

• Record ID: K193299
• Device Name: VITEK 2 AST-Gram Negative Ceftazidime (=<0.5 - =>32 µg/mL)
• Applicant: bioMerieux, Inc.
• Product Code: LON · Microbiology
• Decision Date: Sep 28, 2020
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.1645
• Device Class: Class 2

Intended Use

VITEK® 2 AST-Gram Negative Ceftazidime 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 Ceftazidime is a quantitative test. Ceftazidime 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: Citrobacter species Enterobacter species Escherichia coli Klebsiella species Proteus mirabilis Proteus vulgaris Pseudomonas aeruginosa Serratia species In vitro data are available, but clinical significance is unknown: Acinetobacter species Citrobacter koseri (formerly Citrobacter diversus) Citrobacter freundii Providencia species (including Providencia rettgeri) Salmonella species Shigella species Yersinia enterocolitica 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 Ceftazidime is an automated in vitro diagnostic test for determining minimum inhibitory concentrations (MIC) of ceftazidime against aerobic Gram-negative bacilli. The device uses miniaturized, 64-well test cards containing premeasured antimicrobial concentrations and nutrient media. Clinical laboratories prepare a standardized saline suspension of the patient isolate (via auto-dilution or manual dilution), which rehydrates the card. The VITEK 2 system incubates the card and uses an optical scanner to measure light attenuation every 15 minutes, monitoring bacterial growth. The system's software analyzes growth patterns to calculate MIC values. Results are reported as quantitative MICs and interpretive categories (Susceptible, Intermediate, Resistant). The device aids clinicians in selecting appropriate antimicrobial therapy for infections. Limitations exist for specific organism/antibiotic combinations (e.g., P. aeruginosa at 8 µg/mL) requiring alternative testing methods.

Clinical Evidence

Bench testing only. Performance evaluated using 981 clinical and 118 challenge isolates. Comparison against CLSI broth microdilution reference method showed acceptable essential agreement (EA) and category agreement (CA). For P. aeruginosa, adjusted very major error rate was 2.6% after accounting for MIC values one doubling dilution from reference. Trending analysis identified a bias toward lower MIC values for Yersinia enterocolitica.

Technological Characteristics

Automated growth-based detection system using light transmittance optics. 64-well test card format. Energy source: electrical (VITEK 2/Compact systems). Connectivity: networked/standalone. Software: VITEK 2 Systems 9.02 or later. Standardized inoculum preparation via DensiCHEK Plus. Materials: nutrient media and premeasured antimicrobial concentrations.

Indications for Use

Indicated for antimicrobial susceptibility testing of clinically significant aerobic Gram-negative bacilli (Citrobacter, Enterobacter, E. coli, Klebsiella, Proteus, Pseudomonas, Serratia, Acinetobacter, Providencia, Salmonella, Shigella, Yersinia) in clinical laboratories using VITEK 2 or 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 Eravacycline (K191766)

Submission Summary (Full Text)

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December 15, 2020

BioMerieux, Inc. Cherece Jones Staff Regulatory Affairs Specialist 595 Anglum Rd. Hazelwood, Missouri 63042

Re: K193299

Trade/Device Name: VITEK 2 AST-Gram Negative Ceftazidime (≤0.5 - ≥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, LTT, LTW

Dear Cherece Jones:

The Food and Drug Administration (FDA) is sending this letter to notify you of an administrative change related to your previous substantial equivalence (SE) determination letter dated September 28, 2020. Specifically, FDA is updating this SE Letter (i.e., correct inaccuracies in the Indications for Use form, 510(k) Summary, and device labeling) as an administrative correction.

Please note that the 510(k) submission was not re-reviewed. For questions regarding this letter please contact Ribhi Shawar, Ph.D., OHT7: Office of In Vitro Diagnostics and Radiological Health, 301-796-6698, [e-mail].

Sincerely,

### Ribhi Shawar -S

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 Quality Center for Devices and Radiological Health

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September 28, 2020

bioMérieux, Inc. Cherece Jones Staff Regulatory Affairs Specialist 595 Anglum Rd. Hazelwood, Missouri 63042

#### Re: K193299

Trade/Device Name: VITEK 2 AST-Gram Negative Ceftazidime (≤0.5 - ≥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, LTT, LTW Dated: November 26, 2019 Received: November 27, 2019

Dear Cherece Jones:

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/cfpmp/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 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see

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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 (DICE(@fda.hhs.gov) or phone [phone] or 301-796-7100).

Sincerely,

# Ribhi Shawar -S

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 Quality Center for Devices and Radiological Health

Enclosure

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#### Indications for Use

510(k) Number (if known)

K193299

#### Device Name

VITEK® 2 AST-Gram Negative Ceftazidime (≤ 0.5 - ≥ 32 µg/mL)

#### Indications for Use (Describe)

VITEK® 2 AST-Gram Negative Ceftazidime 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 test. Ceftazidime 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:

Citrobacter species Enterobacter species Escherichia coli Klebsiella species Proteus mirabilis Proteus vulgaris Pseudomonas aeruginosa Serratia species

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

Acinetobacter species Citrobacter koseri (formerly Citrobacter diversus) Citrobacter freundii Providencia species (including Providencia rettgeri) Salmonella species Shigella species Yersinia enterocolitica

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)

X | Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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#### 510(k) SUMMARY

B.

C.

#### VITEK® 2 AST-Gram Negative Ceftazidime (≤0.5 - ≥32 µg/mL)

#### 510(k) Submission Information:

| Submitter's Name: | bioMérieux, Inc. |
|----------------------|----------------------------------------------------------------------------------------------------------------------------|
| Address: | 595 Anglum Road<br>Hazelwood, MO 63042 |
| Contact Person: | Cherece L. Jones<br>Staff Regulatory Affairs Specialist |
| Phone Number: | 314-731-8684 |
| Fax Number: | 314-731-8689 |
| Date of Preparation: | November 26, 2019 |
| Device Name: | |
| Formal/Trade Name: | VITEK® 2 AST-Gram Negative Ceftazidime (≤0.5 - ≥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 Ceftazidime (≤0.5 - ≥32 µg/mL) |
| Predicate Device: | VITEK® 2 AST-GN Eravacycline (≤0.12 - ≥4<br>µg/mL) (K191766) |

#### 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(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/5/Picture/0 description: The image shows the logo for bioMérieux. The logo is a circle with a blue top half and a yellow-green gradient bottom half. The word "BIOMÉRIEUX" is written in white letters in the blue portion of the 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 Ceftazidime (≤0.5 - ≥32 ug/mL) has the following concentrations in the card: 1, 2. 4. 8. and 32ug/mL (equivalent standard method concentration by efficacy in ug/mL).

#### E. Substantial Equivalence Information:

The similarities and differences of the VITEK® 2 AST-GN Ceftazidime (≤0.5 - ≥32 µg/mL) when compared to the predicate device, VITEK® 2 AST-GN Eravacycline ( ≤ 0.12 –> 4 µg/mL), are described in the Table 1 below.

| Table 1: Substantial Equivalence | | |
|----------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Item | Device:<br>VITEK® 2 AST-Gram Negative<br>Ceftazidime<br>( $\leq$ 0.5 - $\geq$ 32 µg/mL) | Predicate:<br>VITEK® 2 AST-GN Eravacycline<br>( $\leq$ 0.12 - $\geq$ 4 µg/mL)<br>(K191766) |
| Intended Use | VITEK® 2 AST-Gram Negative<br>Ceftazidime 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 antimicrobial<br>agents. VITEK® 2 AST-Gram<br>Negative Ceftazidime is a<br>quantitative test. Ceftazidime has<br>been shown to be active against most<br>strains of the microorganisms listed<br>below, according to the FDA label<br>for this antimicrobial.<br><br><b>Active <i>in vitro</i> and in clinical<br/>infections:</b><br><i>Citrobacter</i> species<br><i>Enterobacter</i> species<br><i>Escherichia coli</i> | VITEK® 2 AST-Gram Negative<br>Eravacycline 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 antimicrobial<br>agents. VITEK® 2 AST-Gram<br>Negative Eravacycline is a quantitative<br>test. Eravacycline has been shown to<br>be active against most strains of the<br>microorganisms listed below,<br>according to the FDA label for this<br>antimicrobial.<br><br><b>Active <i>in vitro</i> and in clinical<br/>infections:</b><br><i>Citrobacter freundii</i><br><i>Enterobacter cloacae</i><br><i>Escherichia coli</i> |
| Item | Device:<br>VITEK® 2 AST-Gram Negative<br>Ceftazidime<br>(≤0.5 - ≥32 µg/mL) | Predicate:<br>VITEK® 2 AST-GN Eravacycline<br>( ≤ 0.12 – ≥ 4 µg/mL)<br>(K191766) |
| Similarities | | |
| | Klebsiella species | Klebsiella oxytoca |
| | Proteus mirabilis | Klebsiella pneumoniae |
| | Proteus vulgaris | |
| | Pseudomonas aeruginosa | <i>In vitro</i> data are available, but |
| | Serratia species | clinical significance is unknown: |
| | | Citrobacter koseri |
| | <i>In vitro</i> data are available, but | Klebsiella (Enterobacter) aerogenes |
| | clinical significance is unknown: | |
| | Acinetobacter species | The VITEK® 2 Gram-Negative |
| | Citrobacter koseri (formerly | Susceptibility Card is intended for use |
| | Citrobacter diversus) | with the VITEK® 2 Systems in clinical |
| | Citrobacter freundii | laboratories as an <i>in vitro</i> test to |
| | Providencia species (including | determine the susceptibility of |
| | Providencia rettgeri) | clinically significant aerobic Gram- |
| | Salmonella species | negative bacilli to antimicrobial agents |
| | Shigella species | when used as instructed. |
| | Yersinia enterocolitica | |
| | The VITEK® 2 Gram-Negative | |
| | Susceptibility Card is intended for | |
| | use with the VITEK® 2 Systems in | |
| | clinical laboratories as an <i>in vitro</i> test | |
| | to determine the susceptibility of | |
| | clinically significant aerobic Gram- | |
| | negative bacilli to antimicrobial | |
| | agents when used as instructed. | |
| Test 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 microorganisms | Same |
| Inoculum | Saline suspension of organism | Same |
| Test Card | Gram Negative (AST-GN)<br>Susceptibility Card | Same |
| Analysis Algorithms | Growth Pattern Analysis | Same |
| Instrument | VITEK® 2 and VITEK® 2 Compact<br>Systems | Same |
| Differences | | |
| Antimicrobial Agent | Ceftazidime | Eravacycline |

#### Table 1: Substantial Equivalence

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#### F. Intended Use:

VITEK® 2 AST-Gram Negative Ceftazidime 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 Ceftazidime is a quantitative test. Ceftazidime 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:

Citrobacter species Enterobacter species Escherichia coli Klebsiella species Proteus mirabilis Proteus vulgaris Pseudomonas aeruginosa Serratia species

#### In vitro data are available, but clinical significance is unknown:

Acinetobacter species Citrobacter koseri (formerly Citrobacter diversus) Citrobacter freundii Providencia species (including Providencia rettgeri) Salmonella species Shigella species Yersinia enterocolitica

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 Ceftazidime 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).

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The Premarket Notification (510[k]) presents data in support of VITEK® 2 AST-GN Ceftazidime. 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 Ceftazidime by comparing its performance with the CLSI broth microdilution reference method incubated at 16-20 hrs. The data is representative of performance on both the VITEK® 2 and VITEK® 2 Compact instrument platforms.

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

| Antimicrobial | Comment | Essential Agreement Category | | | | Category Agreement | | | | % Reproducibility |
|---------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------|-----|-----|-----|---------------------|-----------------|----------------|------------------|-------------------|
| | | | | | | | | | | |
| | | % Error | | | | % Error | | | | |
| | | %EA | VME | ME | mE | %CA | VME | ME | mE | |
| Ceftazidime | #, E<br>(Overall) | (1054/1095)<br>96.3 | N/A | N/A | N/A | (1062/1095)<br>97.0 | (9/228)<br>3.9 | (6/863)<br>0.7 | (18/1095)<br>1.6 | 97.04 |
| | #, E<br>Enterobacteri<br>aceae…