Etest Ceftolozane/ Tazobactam (0.016-256 ug/ml)

K170670 · bioMerieux, Inc. · JWY · May 31, 2017 · Microbiology

Device Facts

• Record ID: K170670
• Device Name: Etest Ceftolozane/ Tazobactam (0.016-256 ug/ml)
• Applicant: bioMerieux, Inc.
• Product Code: JWY · Microbiology
• Decision Date: May 31, 2017
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.1640
• Device Class: Class 2

Intended Use

Etest® is a quantitative technique for determination of antimicrobial susceptibility of both nonfastidious Gram negative and Gram positive aerobic bacteria such as Enterobacteriaceae, Pseudomonas, Staphylococcus, and Enterococcus species and fastidious bacteria, such as anaerobes, N. gonorrhoeae, S. pneumoniae, Streptococcus and Haemophilus species. The system comprises a predefined antibiotic gradient which is used to determine the Minimum Inhibitory Concentration (MIC), in Ug/mL, of different antimicrobial agents against microorganisms as tested on agar media using overnight incubation. Etest® Ceftolozane / Tazobactam has been shown to be active against the Gram negative aerobic microorganisms listed below, according to the FDA label for this antimicrobial agent: Active both in vitro and in clinical infections: Enterobacter cloacae Escherichia coli Klebsiella oxytoca Klebsiella pneumoniae Proteus mirabilis Pseudomonas aeruginosa The following in vitro data are available, but clinical significance is unknown: Citrobacter koseri Morganella morganii Proteus vulgaris Providencia rettgeri Providencia stuartii Serratia liquefaciens Serratia marcescens

Device Story

Etest is a thin, inert, non-porous plastic strip with a predefined antibiotic gradient on one side and an MIC reading scale on the other. Used in clinical microbiology laboratories; applied to inoculated agar surfaces. Antibiotic gradient transfers into agar matrix, forming a stable, continuous, exponential concentration gradient. Following overnight incubation, bacterial growth forms a symmetrical inhibition ellipse. The MIC value is determined by visual inspection where the ellipse intersects the strip. Provides quantitative susceptibility data to assist clinicians in selecting appropriate antimicrobial therapy for patients with bacterial infections.

Clinical Evidence

Performance evaluated against CLSI M07-A10 broth microdilution reference method. Study used clinical isolates (fresh and stock) and challenge strains. Results demonstrated 97.2% overall Essential Agreement and 98.6% overall Category Agreement. Reproducibility and Quality Control testing met acceptance criteria.

Technological Characteristics

Thin, inert, non-porous plastic strip; predefined antibiotic gradient; MIC reading scale. Manual antimicrobial susceptibility test system. No energy source required. Sterilization not specified. No software/algorithm.

Indications for Use

Indicated for susceptibility testing of Gram-negative aerobic microorganisms (Enterobacter cloacae, Escherichia coli, Klebsiella oxytoca, Klebsiella pneumoniae, Proteus mirabilis, Pseudomonas aeruginosa) to Ceftolozane/Tazobactam.

Regulatory Classification

Identification

An antimicrobial susceptibility test powder is a device that consists of an antimicrobial drug powder packaged in vials in specified amounts and intended for use in clinical laboratories for determining in vitro susceptibility of bacterial pathogens to these therapeutic agents. Test results are used to determine the antimicrobial agent of choice in the treatment of bacterial diseases.

Predicate Devices

• Etest® Ceftaroline (K151873)

Submission Summary (Full Text)

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

May 31, 2017

BIOMÉRIEUX, INC. CHERECE JONES STAFF REGULATORY AFFAIRS SPECIALIST 595 ANGLUM RD. HAZELWOOD MO 63042

Re: K170670

Trade/Device Name: Etest Ceftolozane/ Tazobactam (0.016-256 us/ml) Regulation Number: 21 CFR 866.1640 Regulation Name: Antimicrobial susceptibility test powder Regulatory Class: II Product Code: JWY Dated: March 3, 2017 Received: March 6, 2017

Dear Ms. Jones:

We have reviewed vour 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. 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 Parts 801 and 809); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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If you desire specific advice for your device on our labeling regulations (21 CFR Parts 801 and 809), please contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

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Sincerely yours,

# Ribhi Shawar -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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# Indications for Use

510(k) Number (if known) K170670

Device Name Etest® Ceftolozane / Tazobactam (0.016 - 256 ug/mL)

#### Indications for Use (Describe)

Etest® is a quantitative technique for determination of antimicrobial susceptibility of both non-fastidious Gram negative and Gram positive aerobic bacteria such as Enterobacteriaceae, Pseudomonas, Staphylococcus, and Enterococcus species and fastidious bacteria, such as anaerobes, N. gonorrhoeae, S. pneumoniae, Streptococus and Haemophilus species. The system comprises a predefined antibiotic gradient which is used to determine the Minimum Inhibitory Concentration (MIC), in ug/mL, of different antimicrobial agents against microorganisms as tested on agar media using overnight incubation.

Etest® Ceftolozane / Tazobactam has been shown to be active against the Gram negative aerobic microorganisms listed below, according to the FDA label for this antimicrobial agent:

#### Active both in vitro and in clinical infections:

Enterobacter cloacae Escherichia coli Klebsiella oxytoca Klebsiella pneumoniae Proteus mirabilis Pseudomonas aeruginosa

### The following in vitro data are available, but clinical significance is unknown:

Citrobacter koseri Morganella morganii Proteus vulgaris Providencia rettgeri Providencia stuartii Serratia liquefaciens Serratia marcescens 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)

#### CONTINUE ON A SEPARATE PAGE IF NEEDED.

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# 510(k) SUMMARY

## Etest® Ceftolozane / Tazobactam

### A. 510(k) Submission Information:

| Submitter's Name: | bioMérieux, SA |
|----------------------|---------------------------------------------------------|
| 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 03, 2017 |

### B. Device Name:

| Formal/Trade Name: | Etest® Ceftolozane / Tazobactam (0.016 - 256 ug/ml) |
|----------------------|-------------------------------------------------------------------------------------------|
| Classification Name: | 21 CFR 866.1640<br>Manual Antimicrobial Susceptibility Test Systems<br>Product Code: JWY |
| Common Name: | Etest® Ceftolozane / Tazobactam |
| C. Predicate Device: | Etest® Ceftaroline (0.002 - 32ug/ml) (K151873) |

### D. Device Description:

Etest® is a thin, inert and non-porous plastic strip carrying on one side (A) the MIC reading scale in ug/mL, and on the other side (B) a predefined antibiotic gradient.

When the strip is applied to an inoculated agar surface, the preformed antibiotic gradient immediately transfers into the agar matrix, then forming a stable, continuous and exponential gradient of antibiotic concentrations directly underneath the strip. Bacterial growth becomes visible during incubation, and a symmetrical inhibition ellipse centered along the strip appears. The MIC value is read from the scale in terms of ug/mL at complete inhibition of bacterial growth, where the pointed end of the ellipse intersects the strip.

# E. Intended Use:

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Etest® is a quantitative technique for determination of antimicrobial susceptibility of both nonfastidious Gram negative and Gram positive aerobic bacteria such as Enterobacteriaceae, Pseudomonas, Staphylococcus, and Enterococcus species and fastidious bacteria, such as anaerobes, N. gonorrhoeae, S. pneumoniae, Streptococcus and Haemophilus species. The system comprises a predefined antibiotic gradient which is used to determine the Minimum Inhibitory Concentration (MIC), in Ug/mL, of different antimicrobial agents against microorganisms as tested on agar media using overnight incubation.

Etest® Ceftolozane / Tazobactam has been shown to be active against the Gram negative aerobic microorganisms listed below, according to the FDA label for this antimicrobial agent:

### Active both in vitro and in clinical infections:

Enterobacter cloacae Escherichia coli Klebsiella oxytoca Klebsiella pneumoniae Proteus mirabilis Pseudomonas aeruginosa

#### The following in vitro data are available, but clinical significance is unknown:

Citrobacter koseri Morganella morganii Proteus vulgaris Providencia rettgeri Providencia stuartii Serratia liquefaciens Serratia marcescens

### F. Performance Overview

Etest Ceftolozane / Tazobactam demonstrated substantially equivalent performance when compared with the CLSI M07-A10 January 2015 broth microdilution reference method, following rules as defined in the FDA Class II Special Controls Guidance Document: Antimicrobial Susceptibility Test (AST) Systems; Guidance for Industry and FDA. Issued on August 28, 2009 and following specifications as defined in CLSI M100-S26 January 2016.

This Premarket Notification (510[k]) presents data in support of Etest® Ceftolozane / Tazobactam for Gram negative aerobic bacteria: Enterobacteriaceae and Pseudomonas aeruginosa. External evaluations were conducted with fresh and stock clinical isolates, as well as a set of challenge strains. The external evaluations were designed to establish the performance of Etest Ceftolozane / Tazobactam by comparing with the CLSI broth microdilution reference method.

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Etest® Ceftolozane/Tazobactam demonstrated acceptable performance of 97.2% overall Essential Agreement and 98.6% overall Category Agreement with the reference method. Reproducibility and Quality Control demonstrated acceptable results.

# G. Conclusion:

The performance data presented in this submission support a substantial equivalence decision. The Etest Ceftolozane/Tazobactam is substantially equivalent to the Etest® Ceftaroline (K151873).