VITEK 2 AST-Gram Negative Imipenem (</=0.25->= 16 ug/mL)

K183415 · bioMerieux, Inc. · LON · Feb 20, 2019 · Microbiology

Device Facts

• Record ID: K183415
• Device Name: VITEK 2 AST-Gram Negative Imipenem (</=0.25->= 16 ug/mL)
• Applicant: bioMerieux, Inc.
• Product Code: LON · Microbiology
• Decision Date: Feb 20, 2019
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.1645
• Device Class: Class 2

Intended Use

VITEK® 2 AST-Gram Negative Imipenem 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 Imipenem is a quantitative test. Imipenem 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: Acinetobacter spp. Citrobacter spp. E.cloacae / E.cloacae complex Escherichia coli Klebsiella spp. Pseudomonas aeruginosa 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 Imipenem is an automated, quantitative in vitro diagnostic test for determining the minimum inhibitory concentration (MIC) of imipenem against aerobic Gram-negative bacilli. The system uses miniaturized test cards containing premeasured antimicrobial concentrations and nutrient media. Clinical laboratories prepare a standardized saline suspension of the bacterial isolate; the VITEK 2 system performs automated dilution, filling, and sealing, while the VITEK 2 Compact requires manual preparation. Cards are incubated within the instrument, which uses an optical scanner to monitor bacterial growth via light attenuation. The system's algorithm analyzes growth patterns to calculate MIC values and interpretive categories (Susceptible, Intermediate, Resistant). Results are reported to clinicians to aid in antimicrobial therapy selection. The device provides rapid susceptibility data, potentially improving patient outcomes by guiding targeted antibiotic treatment.

Clinical Evidence

Bench testing only. Performance evaluated using clinical isolates (fresh and stock) and challenge strains compared to CLSI broth microdilution reference method. Overall performance: 95.9% Essential Agreement, 95.4% Category Agreement. Subgroup performance: Enterobacteriaceae (96.2% EA, 97.0% CA), Acinetobacter spp. (98.3% EA, 98.3% CA), and P. aeruginosa (94.4% EA, 91.0% CA). Reproducibility and Quality Control results were acceptable.

Technological Characteristics

Miniaturized broth microdilution card containing Imipenem concentrations (≤0.25 - ≥16 μg/mL). Automated incubation and optical growth monitoring system. Compatible with VITEK 2 and VITEK 2 Compact platforms. Quantitative MIC determination.

Indications for Use

Indicated for antimicrobial susceptibility testing of clinically significant aerobic Gram-negative bacilli (Acinetobacter spp., Citrobacter spp., E. cloacae complex, E. coli, Klebsiella spp., P. aeruginosa) in clinical laboratories.

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 Amikacin (K172731)

Submission Summary (Full Text)

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FDA U.S. FOOD &amp; DRUG ADMINISTRATION

February 20, 2019

bioMerieux, Inc.
Craig Buehler
Sr. Regulatory Affairs Specialist
595 Anglum Road
Hazelwood, Missouri 63042

Re: K183415
Trade/Device Name: VITEK 2 AST - Gram Negative Imipenem (≤0.25 - ≥16 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, LTW, LTT
Dated: December 7, 2018
Received: December 10, 2018

Dear Craig Buehler:

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 (reporting of medical device-related adverse events) (21 CFR

U.S. Food &amp; Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov

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K183415 - Craig Buehler
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803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

Steven R. Gitterman -S for

Uwe Scherf, M.Sc, Ph.D.

Director

Division of Microbiology Devices

Office of In Vitro Diagnostics

and Radiological Health

Center for Devices and Radiological Health

Enclosure

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FORM FDA 3881 (7/17)
Page 1 of 1
PSC Publishing Services [phone]
EF

| DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Indications for Use | Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below. |
| --- | --- |
| 510(k) Number (if known) K183415 | |
| Device Name VITEK® 2 AST-Gram Negative Imipenem (≤ 0.25 - ≥ 16 μg/mL) | |
| Indications for Use (Describe) VITEK® 2 AST-Gram Negative Imipenem 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 Imipenem is a quantitative test. Imipenem 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: Acinetobacter spp. Citrobacter spp. E.cloacae / E.cloacae complex Escherichia coli Klebsiella spp. Pseudomonas aeruginosa 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) ☑ Prescription Use (Part 21 CFR 801 Subpart D) ☐ Over-The-Counter Use (21 CFR 801 Subpart C) | |
| 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." | |

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BIOMÉRIEUX

# 510(k) SUMMARY

## VITEK® 2 AST-GN Imipenem

### 510(k) Submission Information:

Submitter’s Name: bioMérieux, Inc.
Address: 595 Anglum Road
Hazelwood, MO 63042
Contact Person: Craig Buehler
Sr. Regulatory Affairs Specialist
Phone Number: 314-731-8358
Fax Number: 314-731-8689
Date of Preparation: December 7, 2018

### B. Device Name:

Formal/Trade Name: VITEK® 2 AST-GN Imipenem ($\leq 0.25 - \geq 16\ \mu\mathrm{g/mL}$)
Classification Name: 21 CFR 866.1645
Fully Automated Short-Term Incubation Cycle
Antimicrobial Susceptibility System
Product Code: LON
Common Name: VITEK® 2 AST-GN Imipenem

### C. Predicate Device:

VITEK® 2 AST-GN Amikacin (K172731)

### D. 510(k) Summary:

VITEK® 2 AST-Gram Negative Imipenem 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 Imipenem is a quantitative test. Imipenem 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:
- Acinetobacter spp.
- Citrobacter spp.

bioMérieux, Inc.
595 Anglum Road, Hazelwood, Missouri 63042-2320, USA Phone: [phone] Fax: [phone]
http://www.biomerieux-usa.com
Section 8 - Page 1 of 3

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E.cloacae / E.cloacae complex
Escherichia coli
Klebsiella spp.
Pseudomonas aeruginosa

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.

The antimicrobial presented in VITEK® 2 AST-GN Cards is in concentrations equivalent by efficacy to standard method concentrations in mcg/ml. The VITEK® 2 AST Cards are essentially miniaturized versions of the doubling dilution technique for determining the minimum inhibitory concentration (MIC) microdilution methodology.

The isolate to be tested is diluted to a standardized concentration in 0.45 - 0.50% saline before being used to rehydrate the antimicrobial medium within the card. The VITEK® 2 automatically fills, seals and places the card into the incubator/reader. The VITEK® 2 Compact has a manual filling and sealing operation. The VITEK® 2 monitors the growth of each well in the card over a defined period of time (up to 18 hours). At the completion of the incubation cycle, a report is generated that contains the MIC value along with the interpretive category result for each antimicrobial contained on the card.

VITEK® 2 AST-GN Imipenem 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 Imipenem. 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 Imipenem by comparing its performance with the CLSI broth microdilution reference method incubated at 16-20 hours (20-24 hours for Acinetobacter species). The data is representative of performance on both the VITEK® 2 and VITEK® 2 Compact instrument platforms.

For all organism groups combined, VITEK® 2 AST-GN Imipenem demonstrated acceptable performance of 95.9% overall Essential Agreement and 95.4% overall Category Agreement with the reference method. Reproducibility and Quality Control demonstrated acceptable results.

For the Enterobacteriaceae group, the VITEK® 2 AST-GN Imipenem demonstrated acceptable performance of 96.2% overall Essential Agreement and 97.0% overall Category Agreement with the reference method.

Section 8 - Page 2 of 3

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For the Acinetobacter spp. group, the VITEK® 2 AST-GN Imipenem demonstrated acceptable performance of 98.3% overall Essential Agreement and 98.3% overall Category Agreement with the reference method.

For P. aeruginosa, the VITEK® 2 AST-GN Imipenem demonstrated acceptable performance of 94.4% overall Essential Agreement and 91.0% overall Category Agreement with the reference method.

Section 8 - Page 3 of 3