MicroScan Dried Gram Negative MIC/Combo Panels with Ceftolozane/tazobactam (0.25/4 - 16/4 ug/mL)

K172255 · Beckman Coulter, Inc. · LTT · Dec 1, 2017 · Microbiology

Device Facts

• Record ID: K172255
• Device Name: MicroScan Dried Gram Negative MIC/Combo Panels with Ceftolozane/tazobactam (0.25/4 - 16/4 ug/mL)
• Applicant: Beckman Coulter, Inc.
• Product Code: LTT · Microbiology
• Decision Date: Dec 1, 2017
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.1640
• Device Class: Class 2

Intended Use

The MicroScan Dried Gram-Negative MIC/Combo Panel is used to determine quantitative and/or qualitative antimicrobial agent susceptibility of colonies grown on solid media of rapidly and facultative anaerobic gram-negative bacilli. After inoculation, panels are incubated for 16 - 20 hours at 35°C +/ - 1°C in a non-CO2 incubator, and read either visually or with MicroScan instrumentation, according to the Package Insert. This particular submission is for the antimicrobial ceftolozane/tazobactam at concentrations of 0.25/4 to 16/4 ug/mL to the test panel.

Device Story

MicroScan Dried Gram-Negative MIC/Combo Panels are miniaturized, dehydrated broth dilution susceptibility tests. The device uses Mueller Hinton broth supplemented with calcium and magnesium to test antimicrobial concentrations. Inoculation is performed via Prompt or turbidity methods. Panels are incubated for 16–20 hours at 35°C in a non-CO2 incubator. Results are determined by observing the lowest antimicrobial concentration inhibiting growth, either visually or via MicroScan WalkAway or autoSCAN-4 instrumentation. The device provides MIC values and categorical interpretations (S, I, R) to assist clinicians in selecting appropriate antibiotic therapy for Gram-negative bacterial infections. Limitations exist for specific organisms (e.g., E. cloacae, M. morganii) requiring manual interpretation or retesting with turbidity methods when using specific instrument/inoculation combinations.

Clinical Evidence

Performance evaluated using 575 clinical isolates and 118 challenge isolates (total 693). Study compared MicroScan results to CLSI frozen broth microdilution reference. Essential Agreement (EA) and Category Agreement (CA) were generally >90%. Specific performance issues identified for E. cloacae, M. morganii, P. rettgeri, and S. liquefaciens when using Prompt inoculation with WalkAway/autoSCAN-4, resulting in labeling limitations. MIC trending observed for Enterobacteriaceae (one doubling dilution higher) with WalkAway/Prompt. Reproducibility >95% across all methods.

Technological Characteristics

Miniaturized, dehydrated broth microdilution panels. Energy source: non-CO2 incubator. Inoculation: Prompt or turbidity (0.5 McFarland). Read methods: Visual, MicroScan WalkAway, or autoSCAN-4. Connectivity: Instrument-based automated reading. Materials: Mueller Hinton broth supplemented with calcium and magnesium. Software: Automated growth detection and MIC calculation.

Indications for Use

Indicated for determining quantitative and/or qualitative antimicrobial susceptibility of colonies grown on solid media of rapidly growing aerobic and facultative anaerobic gram-negative bacilli, including Enterobacter cloacae, Escherichia coli, Klebsiella oxytoca, Klebsiella pneumoniae, Proteus mirabilis, Pseudomonas aeruginosa, Citrobacter koseri, Morganella morganii, Proteus vulgaris, Providencia rettgeri, Providencia stuartii, Serratia liquefaciens, and Serratia marcescens.

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

• MicroScan Dried Gram-Negative MIC/Combo Panels with Imipenem (K162740)

Submission Summary (Full Text)

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December 1, 2017

Beckman Coulter, Inc Shannon Popson Staff Regulatory Affairs 1584 Enterprise Blvd West Sacramento, CA 95691

Re: K172255

Trade/Device Name: MicroScan Dried Gram Negative MIC/Combo Panels with Ceftolozane/tazobactam (0.25/4 - 16/4 ug/mL) Regulation Number: 21 CFR 866.1640 Regulation Name: Antimicrobial susceptibility test powder Regulatory Class: Class II Product Code: LTT, LRG, JWY Dated: July 25, 2017 Received: July 26, 2017

Dear Ms. Popson:

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. 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); 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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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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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,

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) K172255

#### Device Name

MicroScan Dried Gram-Negative MIC/Combo Panels with Ceftolozane/Tazobactam (0.25/4 - 16/4 µg/mL)

#### Indications for Use (Describe)

The MicroScan Dried Gram-Negative MIC/Combo Panel is used to determine quantitative and/or qualitative antimicrobial agent susceptibility of colonies grown on solid media of rapidly and facultative anaerobic gram-negative bacilli. After inoculation, panels are incubated for 16 - 20 hours at 35°C +/ - 1°C in a non-CO2 incubator, and read either visually or with MicroScan instrumentation, according to the Package Insert. This particular submission is for the antimicrobial ceftolozane/tazobactam at concentrations of 0.25/4 to 16/4 ug/mL to the test panel.

Ceftolozane/azobactam has been shown to be active both clinically and in vitro against the following organisms: Enterobacter cloacae, Escherichia coli, Klebsiella pneumoniae, Proteus mirabilis, and Pseudomonas aeruginosa

In vitro data is available for the following organisms, but their clinical significance is unknown: Citrobacter koseri, Morganii, Proteus vulgaris, Providencia retteeri, Providencia stuartii, Serratia liquefaciens, and Serratia marcescens

| Type of Use (Select one or both, as applicable) | |
|---------------------------------------------------------------------------------------|--|
| <div> <span> </span> <span>Prescription Use (Part 21 CFR 801 Subpart D)</span> </div> | |
| <div> <span> </span> <span>Over-The-Counter Use (21 CFR 801 Subpart C)</span> </div> | |

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# 510(k) Summarv

### 510(k) Submission Information:

| Device Manufacturer: | Beckman Coulter |
|----------------------|-----------------------------------------------------------------------------------------------------|
| Contact name: | Shannon Popson, Staff Regulatory Affairs |
| Phone: | 916-374-3330 |
| Fax: | 916-374-2119 |
| Date prepared: | October 23, 2017 |
| Product Name: | Microdilution Minimum Inhibitory Concentration (MIC) Panels |
| Trade Name: | MicroScan Dried Gram-Negative MIC/Combo Panels with Ceftolozane/Tazobactam<br>(0.25/4 — 16/4 µg/mL) |
| Intended Use: | To determine antimicrobial agent susceptibility |
| Classification: | Class II |
| Product Code: | LTT |
| 510(k) Notification: | New antimicrobial agent - Ceftolozane/Tazobactam |
| Predicate device: | MicroScan Dried Gram-Negative MIC/Combo Panels - Imipenem (K162740) |

#### 510(k) Summary:

MicroScan Dried Gram-Neqative MIC/Combo Panels are designed for use in determining quantitative and/or qualitative antimicrobial agent susceptibility of colonies grown on solid media of rapidly growing aerobic and facultative anaerobic gram-negative bacilli.

The antimicrobial susceptibility tests are miniaturizations of the broth dilution susceptibility test that have been diluted in broth and dehydrated. Various antimicrobial agents are diluted in broth to concentrations bridging the range of clinical interest. Panels are rehydrated with water after inoculation with a standardized suspension of the organism. After incubation in a non-CO2 incubator for 16-20 hours, the minimum inhibitory concentration (MIC) for the test organism is read by determining the lowest antimicrobial concentration showing inhibition of growth.

The proposed MicroScan Dried Gram-Negative MIC/Combo Panel demonstrated substantially equivalent performance when compared with a CLSI frozen Reference Panel, as defined in the FDA document " Class II Special Controls Guidance Document: Antimicrobial Susceptibility Test (AST) Systems; Guidance for Industry and FDA", dated August 28, 2009. The Premarket Notification (510[k]) presents data in support of the MicroScan Dried Gram-Negative MIC/Combo Panel with ceftolozane/tazobactam.

The external evaluations were conducted with fresh, recent and stock Efficacy isolates and stock Challenge strains. The external evaluations were designed to confirm the acceptability of the proposed Dried Gram-Negative Panel by comparing its performance with a CLSI frozen Reference panel. The Dried Gram-Negative Panel demonstrated acceptable performance with an overall Essential Agreement of 92,8% for ceftolozane/ tazobactam when compared with the frozen Reference panel.

Inoculum and instrument reproducibility testing demonstrated acceptable reproducibility and precision with ceftolozane/tazobactam, regardless of which inoculum method (i.e., Turbidity or Prompt™), or instrument (autoSCAN-4 instrument or WalkAway system) was used.

Quality Control testing demonstrated acceptable results for ceftolozane/tazobactam.

Beckman Coulter, the stylized logo, MicroScan, and WalkAway are trademarks of Beckman Coulter and the stylized logo are registered with the USPTO.

Prompt™ is a trademark of 3M Company, St. Paul, MN USA