VITEK 2 AST-Gram Positive Delafloxacin (<=0.015 - >=1 µg/mL)

K200590 · bioMerieux, Inc. · LON · Apr 28, 2020 · Microbiology

Device Facts

• Record ID: K200590
• Device Name: VITEK 2 AST-Gram Positive Delafloxacin (<=0.015 - >=1 µg/mL)
• Applicant: bioMerieux, Inc.
• Product Code: LON · Microbiology
• Decision Date: Apr 28, 2020
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.1645
• Device Class: Class 2

Intended Use

VITEK® 2 AST-Gram Positive Delafloxacin is designed for antimicrobial susceptibility testing of Gram positive microorganisms 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 Positive 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. Active in vitro and in clinical infections: Acute Bacterial Skin and Skin Structure Infections (ABSSSI): Staphylococcus aureus (including methicillin-resistant and methicillin-susceptible isolates) Streptococcus agalactiae Enterococcus faecalis Community-Acquired Bacterial Pneumonia (CABP): Staphylococcus aureus (methicillin-susceptible isolates only) The VITEK® 2 Gram-positive Susceptibility Card is intended for use with the VITEK® 2 Systems in clinical laboratories as an in vitro test to determine the susceptibility of Staphylococcus spp., Enterococcus spp., and S. agalactiae to antimicrobial agents when used as instructed.

Device Story

VITEK 2 AST-Gram Positive Delafloxacin is an automated, miniaturized, broth-based dilution test for determining minimum inhibitory concentrations (MIC). System uses 64-well cards containing premeasured antimicrobial concentrations and nutrient media. Input: bacterial isolate suspension (standardized via DensiCHEK Plus). Operation: VITEK 2/VITEK 2 Compact systems fill, seal, and incubate cards; optical scanner measures light attenuation every 15 minutes to monitor growth. Output: MIC values and interpretive category results. Used in clinical laboratories by technicians/microbiologists. Results assist clinicians in selecting appropriate antimicrobial therapy for ABSSSI and CABP. Benefits include standardized, automated susceptibility reporting.

Clinical Evidence

External evaluation using contemporary, stock, and challenge clinical isolates. Compared VITEK 2 AST-GP Delafloxacin performance against CLSI broth microdilution reference method. Overall Essential Agreement (EA) 96.6% and Categorical Agreement (CA) 94.0% for ABSSSI isolates. Reproducibility 100%.

Technological Characteristics

Miniaturized, automated broth microdilution card; 64-well format. Sensing: optical scanner measuring light attenuation (transmittance). Energy: visible light. Connectivity: VITEK 2/VITEK 2 Compact systems. Software: VITEK 2 Systems 9.04 or later. Sterilization: not specified.

Indications for Use

Indicated for antimicrobial susceptibility testing of Gram-positive microorganisms (Staphylococcus spp., Enterococcus spp., and S. agalactiae) in clinical laboratories 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-Gram Positive Dalbavancin (K190616)

Submission Summary (Full Text)

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April 28, 2020

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

Re: K200590

Trade/Device Name: VITEK 2 AST-Gram Positive Delafloxacin (≤0.015 - ≥1 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: March 4, 2020 Received: March 6, 2020

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/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. 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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### 510(k) SUMMARY

C.

# VITEK® 2 AST-Gram Positive Delafloxacin (≤0.015-≥1 µg/mL)

### A. 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: | March 4, 2020 |
| B. Device Name: | |
| Formal/Trade Name: | VITEK® 2 AST-Gram Positive Delafloxacin (≤0.015 - ≥1 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-GP Delafloxacin (≤0.015 - ≥1 µg/mL) |
| C. Predicate Device: | VITEK® 2 AST-Gram Positive Dalbavancin (≤0.015 -<br>≥1 µg/mL) (K190616) |
| 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).

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

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specific antibiotic combined with culture media. The 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.

### E. Substantial Equivalence Information:

The similarities and differences of the VITEK® 2 AST-GP Delafloxacin (≤0.015-≥1 µg/mL) when compared to the predicate device, VITEK® 2 AST-Gram Positive Dalbavancin (≤0.015 ->1 ug/mL), are described in the Table 1 below.

| Item | Device:<br>VITEK® 2 AST-GP Delafloxacin<br>(≤0.015 - ≥1 µg/mL) | Predicate:<br>VITEK® 2 AST-Gram Positive<br>Dalbavancin (≤0.015 - ≥1 µg/mL)<br>(K190616) |
|--------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Similarities | |
| Intended Use | VITEK® 2 AST-Gram Positive<br>Delafloxacin is designed for<br>antimicrobial susceptibility testing of<br>Gram positive microorganisms and is<br>intended for use with the VITEK® 2<br>and VITEK® 2 Compact Systems as<br>a laboratory aid in the determination<br>of <i>in vitro</i> susceptibility to<br>antimicrobial agents. VITEK® 2<br>AST-Gram Positive Delafloxacin is a<br>quantitative test. Delafloxacin 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>Active <i>in vitro</i> and in clinical<br>infections:<br>Acute Bacterial Skin and Skin<br>Structure Infections (ABSSSI):<br><i>Staphylococcus aureus</i> (including<br>methicillin-resistant and methicillin-<br>susceptible isolates)<br><i>Streptococcus agalactiae</i><br><i>Enterococcus faecalis</i><br><br>Community-Acquired Bacterial | VITEK® 2 AST-Gram Positive<br>Dalbavancin is designed for<br>antimicrobial susceptibility testing of<br>Gram positive microorganisms and is<br>intended for use with the VITEK® 2<br>and 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 Positive<br>Dalbavancin is a quantitative test.<br>Dalbavancin 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.<br><br>Active both <i>in vitro</i> and in clinical<br>infections<br><i>Staphylococcus aureus</i> (including<br>methicillin-resistant isolates)<br><i>Enterococcus faecalis</i> (vancomycin-<br>susceptible isolates only)<br><i>Streptococcus agalactiae</i><br><br>The VITEK® 2 Gram-positive<br>Susceptibility Card is intended for use<br>with the VITEK® 2 Systems in clinical |

#### Table 1: Substantial Equivalence

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| Item | Device:<br>VITEK® 2 AST-GP Delafloxacin<br>(≤0.015 - ≥1 µg/mL) | Predicate:<br>VITEK® 2 AST-Gram Positive<br>Dalbavancin (≤0.015 - ≥1 µg/mL)<br>(K190616) |
|---------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Similarities | | |
| | Pneumonia (CABP):<br>Staphylococcus aureus (methicillin-<br>susceptible isolates only)<br>The VITEK® 2 Gram-positive<br>Susceptibility Card is intended for<br>use with the VITEK® 2 Systems in<br>clinical laboratories as an in vitro test<br>to determine the susceptibility of<br>Staphylococcus spp., Enterococcus<br>spp., and S. agalactiae to<br>antimicrobial agents when used as<br>instructed. | laboratories as an in vitro test to<br>determine the susceptibility of<br>Staphylococcus spp., Enterococcus<br>spp., and S. agalactiae to<br>antimicrobial agents when used as<br>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 in vitro<br>susceptibility of microorganisms | Same |
| Inoculum | Saline suspension of organism | Same |
| Test Card | Gram Positive (AST-GP)<br>Susceptibility Card | Same |
| Analysis Algorithms | Growth Pattern Analysis | Same |
| Instrument | VITEK® 2 and VITEK® 2 Compact<br>Systems | Same |
| Differences | | |
| Antimicrobial Agent | Delafloxacin | Dalbavancin |
| Concentrations | 0.008, 0.03, 0.06, 0.25 | 0.0625, 0.125, 0.25, 0.5 |

### F. Indications for Use:

VITEK® 2 AST-Gram Positive Delafloxacin is designed for antimicrobial susceptibility testing of Gram positive microorganisms 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 Positive 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.

### Active in vitro and in clinical infections: Acute Bacterial Skin and Skin Structure Infections (ABSSSI):

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Staphylococcus aureus (including methicillin-resistant and methicillin-susceptible isolates) Streptococcus agalactiae Enterococcus faecalis

## Community-Acquired Bacterial Pneumonia (CABP):

Staphylococcus aureus (methicillin-susceptible isolates only)

The VITEK® 2 Gram-positive Susceptibility Card is intended for use with the VITEK® 2 Systems in clinical laboratories as an in vitro test to determine the susceptibility of Staphylococcus spp., Enterococcus spp., and S. agalactiae to antimicrobial agents when used as instructed.

### G. Performance Overview and Conclusion:

VITEK® 2 AST-Gram Positive 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-Gram Positive Delafloxacin. An external evaluation was conducted with contemporary 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-Gram Positive Delafloxacin by comparing its performance with the CLSI broth microdilution reference method incubated at 16-20 hrs for Staphylococci and Enterococci and 20-24 hrs for Streptococci. The data is representative of performance on both the VITEK® 2 Compact instrument platforms.

The VITEK® 2 AST-Gram Positive Delafloxacin demonstrated acceptable performance as presented in Table 2 below:

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| Antimicrobial | Comment | Essential Agreement Category | | | | Category Agreement | | | | % Reproducibility |
|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------|------------------------------|-----|-----|-----|--------------------|-----------------|-----------------|------------------|-------------------|
| | | %EA | VME | ME | mE | %CA | VME | ME | mE | |
| | #, E<br>ABSSSI<br>(Overall) | (737/763)<br>96.6% | N/A | N/A | N/A | (717/763)<br>94.0% | (2/136)<br>1.5% | (3/594)<br>0.5% | (41/763)<br>5.4% | |
| | #, E<br>ABSSSI (E.<br>faecalis) | (342/360)<br>95.0% | N/A | N/A | N/A | (340/360)<br>94.4% | (2/98)<br>2.0% | (1/252)<br>0.4% | (17/360)<br>4.7% | |
| Delafloxacin | #, E<br>ABSSSI<br>(MSSA+MRS<br>A) | (320/326)<br>98.2% | N/A | N/A | N/A | (300/326)<br>92.0% | (0/36)<br>0.0% | (2/267)<br>0.7% | (24/326)<br>7.4% | 100.0 |
| | #, E<br>ABSSSI<br>(S.agalactiae) | (75/77)<br>97.4% | N/A | N/A | N/A | (77/77)<br>100% | (0/2)<br>0.0% | (0/75)<br>0.0% | (0/77)<br>0.0% | |
| | #, E<br>CABP<br>(MSSA) | (169/170)<br>99.4% | N/A | N/A | N/A | (165/170)<br>97.1% | (0/7)<br>0.0% | (0/155)<br>0.0% | (5/170)<br>2.9% | |
| NOTE: VITEK® 2 AST-Gram Positive Delafloxacin MIC values tended to be in exact agreement or at least one doubling dilution higher<br>when testing Staphylococcus aureus compared to the CLSI reference broth microdilution method. | | | | | | | | | | |
| NOTE: When evaluating performance of the challenge isolates on the manual dilution option for the VITEK® 2 and VITEK® 2 Compact,<br>testing with MRSA isolates yielded an EA of 85% (17/20) and an CA of 80% (16/20). For challenge isolates on the auto dilution option for<br>the VITEK® 2, testing with MRSA isolates yielded an EA of 85% (17/20) and an CA of 85% (17/20). All categorical errors were<br>considered minor | | | | | | | | | | |

## Toblo 21 VITEY® 2 AST Crom Pocitive Dolofloxacin Parfarmon

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

E = External performance data

Quality Control demonstrated acceptable results.

#### 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.

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- 3. Barry, A.L., The Antimicrobic Susceptibility Test, Principles and Practices, Lea and Febiger, Philadelphia, PA, 1976.