VITEK2 AST-Gram Negative Delafloxacin (<=0.06->=4 ug/mL)

K183524 · bioMerieux, Inc. · LON · Mar 12, 2019 · Microbiology

Device Facts

• Record ID: K183524
• Device Name: VITEK2 AST-Gram Negative Delafloxacin (<=0.06->=4 ug/mL)
• Applicant: bioMerieux, Inc.
• Product Code: LON · Microbiology
• Decision Date: Mar 12, 2019
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.1645
• Device Class: Class 2

Intended Use

VITEK® 2 AST-Gram Negative Delafloxacin 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. The VITEK® 2 Antimicrobial Susceptibility Test (AST) is intended to be used with the VITEK® 2 Systems for the automated quantitative or qualitative susceptibility testing of isolated colonies for the most clinically significant aerobic gram-negative bacilli, Staphylococcus spp., Enterococcus spp., Streptococcus spp. and clinically significant yeast.

Device Story

VITEK 2 AST-GN Delafloxacin is an automated, miniaturized, broth-based dilution system for determining minimum inhibitory concentrations (MIC) of delafloxacin against Gram-negative bacilli. Input: standardized saline suspension of clinical isolates. Operation: system fills, seals, and incubates cards containing premeasured antimicrobial concentrations; optical scanner monitors growth via light attenuation in 64 micro-wells over time. Output: MIC values and interpretive category results (S/I/R) generated automatically. Used in clinical laboratories by technicians/microbiologists. Results assist clinicians in selecting appropriate antimicrobial therapy for patients with infections caused by susceptible organisms.

Clinical Evidence

Bench testing only. Performance evaluated using 404 clinical and 206 challenge isolates (total 609 results). Overall performance: 98.0% Essential Agreement (EA) and 95.9% Category Agreement (CA). Major error rate 0.7% (2/291 susceptible isolates); minor error rate 3.7%. Growth failure rate 0.25%. Reproducibility >99%. Trending analysis showed higher MIC values for Enterobacteriaceae compared to reference method, addressed in labeling.

Technological Characteristics

Miniaturized broth microdilution card; automated optical growth monitoring; incubation up to 18 hours. Compatible with VITEK 2 and VITEK 2 Compact platforms. Quantitative measurement of MIC. No specific materials or software algorithm class (e.g., ML) specified beyond standard automated incubation/reading.

Indications for Use

Indicated for antimicrobial susceptibility testing of isolated colonies of clinically significant aerobic gram-negative bacilli, including Enterobacter cloacae, Escherichia coli, Klebsiella pneumoniae, and Pseudomonas aeruginosa, to determine in vitro susceptibility to Delafloxacin.

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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March 12, 2019

bioMerieux, Inc. Esther Hernandez Regulatory Affairs Specialist 595 Anglum Road Hazlewood, Missouri 63042

## Re: K183524

Trade/Device Name: VITEK2 AST-Gram Negative Delafloxacin (≤0.06 - ≥4 ug/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 18, 2018 Received: December 19, 2018

Dear Ms. 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 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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; 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,

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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# Indications for Use

510(k) Number (if known)

Device Name

Indications for Use (Describe)

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)

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VITEK® 2 AST-GN Delafloxacin Traditional 510(k) Submission

## 510(k) SUMMARY

# VITEK® 2 AST-GN Delafloxacin

### 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: | December 19, 2018 |
| B. Device Name: | |
| Formal/Trade Name: | VITEK® 2 AST- GN Delafloxacin (≤ 0.06 – ≥ 4<br>ug/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 Delafloxacin |
| C. Predicate Device: | VITEK® 2 AST-GN Amikacin (K172731) |

### D. 510(k) Summary:

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

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

VITEK® 2 AST-GN Delafloxacin Traditional 510(k) Submission

Active in vitro and in clinical infections: Enterobacter cloacae Escherichia coli Klebsiella pneumoniae Pseudomonas aeruginosa

The VITEK® 2 Antimicrobial Susceptibility Test (AST) is intended to be used with the VITEK® 2 Systems for the automated quantitative or qualitative susceptibility testing of isolated colonies for the most clinically significant aerobic gram-negative bacilli, Staphylococcus spp., Enterococcus spp., Streptococcus spp. and clinically significant yeast.

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 Delafloxacin 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 Delafloxacin. 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 Delafloxacin by comparing its performance with the CLSI broth microdilution reference method incubated at 16-20 hours. The data is representative of performance on both the VITEK® 2 and VITEK® 2 Compact instrument platforms. VITEK® 2 AST-GN Delafloxacin demonstrated acceptable performance of 98.0% overall Essential Agreement and 95.9% overall Category Agreement with the reference method. Reproducibility and Ouality Control demonstrated acceptable results.