MicroScan Dried Gram Negative MIC/Combo Panels with Ceftazidime/Avibactam (0.25/4 - 64/4 ug/mL)

K172337 · Beckman Coulter, Inc. · LTT · Dec 15, 2017 · Microbiology

Device Facts

• Record ID: K172337
• Device Name: MicroScan Dried Gram Negative MIC/Combo Panels with Ceftazidime/Avibactam (0.25/4 - 64/4 ug/mL)
• Applicant: Beckman Coulter, Inc.
• Product Code: LTT · Microbiology
• Decision Date: Dec 15, 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 growing aerobic 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 ceftazidime/avibactam at concentrations of 0.25/4 to 64/4 ug/mL to the test panel. The gram-negative organisms which may be used for ceftazidime/avibactam susceptibility testing in this panel are: Citrobacter freundii complex, Citrobacter koseri, Enterobacter cloacae, Escherichia coli, Klebsiella oxytoca. Klebsiella pneumoniae, Morganii, Proteus mirabilis. Pseudomonas aeruginosa. Providencia rettgeri, Providencia stuartii, and Serratia marcescens

Device Story

MicroScan Dried Gram-Negative MIC/Combo Panels determine antimicrobial susceptibility of gram-negative bacilli. Device uses dehydrated miniaturized broth microdilution; Mueller Hinton broth supplemented with calcium/magnesium. Inoculation via turbidity or Prompt Inoculation System; incubation 16–20 hours at 35°C. Read methods include manual visual inspection or automated MicroScan WalkAway/autoSCAN-4 instruments. Output is Minimum Inhibitory Concentration (MIC) and categorical interpretation (SIR). Used in clinical microbiology laboratories to guide antibiotic therapy for gram-negative infections. Provides quantitative susceptibility data to assist clinicians in selecting appropriate antimicrobial treatment.

Clinical Evidence

Bench-only study. Evaluated 539 clinical and 87 challenge Enterobacteriaceae isolates, plus 79 clinical and 29 challenge P. aeruginosa isolates. Compared MicroScan panels (Prompt/Turbidity inoculation; Manual/WalkAway/autoSCAN-4 read) against frozen broth microdilution reference. Overall essential agreement (EA) and category agreement (CA) were ≥90%. Adjusted very major error rates were 0% for Enterobacteriaceae and 7.7% for P. aeruginosa. Limitations noted for P. rettgeri, S. marcescens, P. stuartii, and P. aeruginosa due to error rates or lack of resistant strains.

Technological Characteristics

Miniaturized broth microdilution panels; dehydrated antimicrobial agents in wells. Rehydrated with water. Incubation: 16-20 hours at 35°C. Compatible with visual reading or automated instrumentation (autoSCAN-4, WalkAway).

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, specifically: Citrobacter freundii complex, Citrobacter koseri, Enterobacter aerogenes, Enterobacter cloacae, Escherichia coli, Klebsiella oxytoca, Klebsiella pneumoniae, Morganella morganii, Proteus mirabilis, Pseudomonas aeruginosa, Providencia rettgeri, Providencia stuartii, 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 - Imipenem (K162740)

Submission Summary (Full Text)

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December 15, 2017

Beckman Coulter, Inc. Teresa Wong Senior Regulatory Analyst 1584 Enterprise Blvd. West Sacramento, California 95691

## Re: K172337

Trade/Device Name: MicroScan Dried Gram Negative MIC/Combo Panels with Ceftazidime/Avibactam (0.25/4 - 64/4 ug/mL) Regulation Number: 21 CFR 866.1640 Regulation Name: Antimicrobial susceptibility test powder Regulatory Class: Class II Product Codes: LTT. JWY. LRG. LTW Dated: August 1, 2017 Received: August 2, 2017

## Dear Teresa Wong:

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

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Part 820); 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 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) K172337

#### Device Name

MicroScan Dried Gram-Negative MIC/Combo Panels with Ceftazidime/Avibactam (0.25/4 - 64/4 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 growing aerobic 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 ceftazidime/avibactam at concentrations of 0.25/4 to 64/4 ug/mL to the test panel.

The gram-negative organisms which may be used for ceftazidime/avibactam susceptibility testing in this panel are:

Citrobacter freundii complex, Citrobacter koseri, Enterobacter cloacae, Escherichia coli, Klebsiella oxytoca. Klebsiella pneumoniae, Morganii, Proteus mirabilis. Pseudomonas aeruginosa. Providencia rettgeri, Providencia stuartii, and Serratia marcescens

| Type of Use (Select one or both, as applicable) | |
|----------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------|
| <div> <span> <span style="font-size: 16px;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) </span> </div> | <div> <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: | Teresa Wong, Senior Analyst Regulatory Affairs |
| Phone: | 916-374-2432 |
| Fax: | 916-374-2119 |
| Date prepared: | October 27, 2017 |
| Product Name: | Microdilution Minimum Inhibitory Concentration (MIC) Panels |
| Trade Name: | MicroScan Dried Gram-Negative MIC/Combo Panels with Ceftazidime/Avibactam<br>(0.25/4 – 64/4 µg/mL) |
| Intended Use: | To determine antimicrobial agent susceptibility |
| Classification: | Class II |
| Product Code: | LTT |
| 510(k) Notification: | New antimicrobial agent - Ceftazidime/Avibactam |
| 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 an 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 ceftazidime/avibactam.

The external evaluations were conducted with fresh 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 95% for Enterobacteriaceae and 96.3% for Pseudomonas aeruginosa when using our most common inoculum and read method for ceftazidime/avibactam when compared with the frozen Reference panel.

Inoculum and instrument reproducibility testing demonstrated acceptable reproducibility and precision with ceftazidime/avibactam, 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 ceftazidime/avibactam.

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