MicroScan Dried Gram Negative MIC/Combo Panels with Eravacycline (ERV) (0.016-32 ug/mL)

K190109 · Beckman Coulter, Inc. · JWY · Apr 18, 2019 · Microbiology

Device Facts

• Record ID: K190109
• Device Name: MicroScan Dried Gram Negative MIC/Combo Panels with Eravacycline (ERV) (0.016-32 ug/mL)
• Applicant: Beckman Coulter, Inc.
• Product Code: JWY · Microbiology
• Decision Date: Apr 18, 2019
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.1640
• Device Class: Class 2

Intended Use

To determine antimicrobial agent susceptibility

Device Story

MicroScan Dried Gram-Negative MIC/Combo Panels are miniaturized broth microdilution tests for antimicrobial susceptibility. The device uses dehydrated Mueller Hinton broth supplemented with calcium and magnesium, containing eravacycline (0.016–32 µg/mL). Clinical laboratory personnel inoculate the panel using either a turbidity-based method or the Prompt Inoculation System. Panels are incubated at 35°C for 16–20 hours in a non-CO2 incubator. Results are determined by observing the lowest concentration inhibiting visible growth, either visually or via automated MicroScan WalkAway or autoSCAN-4 instrumentation. The output is a Minimum Inhibitory Concentration (MIC) and categorical interpretation (Susceptible). The device assists clinicians in selecting appropriate antibiotic therapy for gram-negative bacterial infections. Limitations exist regarding specific organism/method combinations due to potential errors, requiring manual read confirmation for certain results.

Clinical Evidence

Performance evaluated using 414 clinical and 79 challenge isolates of Enterobacteriaceae. Overall essential agreement (EA) and category agreement (CA) were ≥90% across all inoculation (Turbidity, Prompt) and read methods (Manual, WalkAway, autoSCAN-4). Adjusted very major error rate was 0% after accounting for essential agreement. Trending analysis showed a tendency toward lower MIC readings for certain method combinations, which is addressed in device labeling. No clinical sensitivity/specificity data reported; bench-based performance testing only.

Technological Characteristics

Miniaturized broth microdilution panel; dehydrated Mueller Hinton broth with calcium/magnesium. Inoculation: Turbidity (0.5 McFarland equivalent) or Prompt system. Incubation: 35°C ± 1°C, 16-20 hours. Read methods: Manual, WalkAway, or autoSCAN-4. Connectivity: Standalone or networked via MicroScan instrumentation. Standards: CLSI M07-A11, CLSI M100.

Indications for Use

Indicated for quantitative and/or qualitative antimicrobial susceptibility testing of aerobic and facultatively anaerobic gram-negative bacilli (Citrobacter freundii, Citrobacter koseri, Enterobacter cloacae, Enterobacter cloacae complex, Escherichia coli, Klebsiella aerogenes, Klebsiella oxytoca, Klebsiella pneumoniae) grown on solid media. For prescription use only.

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 Ceftazidime/Avibactam (K172337)

Submission Summary (Full Text)

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# 510(k) Summarv

#### 510(k) Submission Information:

| Device Manufacturer: | Beckman Coulter |
|----------------------|---------------------------------------------------------------------------------------------|
| Contact name: | Elaine Duncan, Senior Analyst Regulatory Affairs |
| Phone: | 916-374-3279 |
| Fax: | 916-374-2480 |
| Date prepared: | January 22, 2019 |
| Product Name: | Microdilution Minimum Inhibitory Concentration (MIC) Panels |
| Trade Name: | MicroScan Dried Gram-Negative MIC/Combo Panels with Eravacycline (ERV) (0.016-<br>32 µg/mL) |
| Intended Use: | To determine antimicrobial agent susceptibility |
| Classification: | Class II |
| Product Code: | LTT |
| 510(k) Notification: | New antimicrobial agent - Eravacycline |
| Predicate device: | MicroScan Dried Gram-Negative MIC/Combo Panels Ceftazidime/Avibactam -<br>(K172337) |

#### 510(k) Summary:

MicroScan Dried Gram-Negative 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-neqative 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 eravacycline.

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 96.8% for eravacycline when compared with the frozen Reference panel.

Inoculum and instrument reproducibility testing demonstrated acceptable reproducibility and precision with eravacycline, 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 eravacycline.

Beckman Coulter, the stylized logo, and the Beckman Coulter product and service marks or registered trademarks of Beckman Coulter, Inc. in the United States and other countries.

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

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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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### April 18, 2019

Beckman Coulter, Inc. Elaine Duncan Senior Analyst Regulatory Affairs 1584 Enterprise Blvd. West Sacramento, California 95691

## Re: K190109

Trade/Device Name: MicroScan Dried Gram Negative MIC/Combo Panels with Eravacycline (ERV) (0.016-32 ug/mL) Regulation Number: 21 CFR 866.1640 Regulation Name: Antimicrobial susceptibility test powder Regulatory Class: Class II Product Code: JWY, LTT, LRG, LTW Dated: January 22, 2019 Received: January 23, 2019

## Dear Elaine Duncan:

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

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801 and Part 809); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); 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 mediation-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