MicroScan Dried Gram-Negative MIC/Combo Panels with Meropenem (Mer) (0.004-32 µg/mL)

K201423 · Beckman Coulter, Inc. · LTT · Jun 29, 2020 · Microbiology

Device Facts

• Record ID: K201423
• Device Name: MicroScan Dried Gram-Negative MIC/Combo Panels with Meropenem (Mer) (0.004-32 µg/mL)
• Applicant: Beckman Coulter, Inc.
• Product Code: LTT · Microbiology
• Decision Date: Jun 29, 2020
• Decision: SESE
• Submission Type: Special
• 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 utilize broth microdilution to determine minimum inhibitory concentrations (MIC) of meropenem for gram-negative bacteria. Panels contain dehydrated antimicrobial agents; clinical samples are inoculated into the panel using either Prompt or Turbidity methods. Following incubation, panels are read via automated systems (WalkAway, autoSCAN 4) or manual visual inspection. The device provides quantitative MIC results, which clinicians use to guide antibiotic therapy selection for patients with gram-negative infections. The modification adds Acinetobacter spp. to the existing indications for meropenem testing. The device is used in clinical microbiology laboratories by trained laboratory personnel.

Clinical Evidence

Bench testing only. Performance evaluated using fresh and stock efficacy and challenge isolates of Acinetobacter spp. compared to CLSI frozen reference panels. Results showed 91.1% Essential Agreement and 98.2% Categorical Agreement for Meropenem. Reproducibility and precision testing confirmed acceptable performance across both Prompt and Turbidity inoculum methods and both WalkAway and autoSCAN-4 instrument platforms. Quality control testing met acceptance criteria.

Technological Characteristics

Miniaturized broth microdilution panels; dehydrated antimicrobial agents. Inoculation via standardized suspension (Turbidity or Prompt method). Incubation 16-20 hours at non-CO2 conditions. Readout via automated instrumentation (WalkAway or autoSCAN-4).

Indications for Use

Indicated for determining quantitative and/or qualitative antimicrobial agent susceptibility of rapidly growing aerobic and facultative anaerobic gram-negative bacilli, including Acinetobacter spp., using colonies grown on solid media.

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 Meropenem (K192355)

Submission Summary (Full Text)

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June 29, 2020

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

Re: K201423

Trade/Device Name: MicroScan Dried Gram-Negative MIC/Combo Panels with Meropenem (Mer) (0.004-32 ug/mL) Regulation Number: 21 CFR 866.1640 Regulation Name: Antimicrobial Susceptibility Test Powder Regulatory Class: Class II Product Code: LTT, JWY, LRG, LTW Dated: May 26, 2020 Received: May 29, 2020

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

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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) 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 (OS) 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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## Special 510(k) Summary

## 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: | May 26, 2020 |
| Product Name: | Microdilution Minimum Inhibitory Concentration (MIC) Panels |
| Trade Name: | MicroScan Dried Gram-Negative MIC/Combo Panels with Meropenem (Mer)<br>(0.004 - 32 µg/mL) |
| Intended Use: | To determine antimicrobial agent susceptibility |
| Classification: | Class II |
| Product Code: | LTT |
| Special 510(k) Notification: | Additional Indications for Use – Acinetobacter spp. with Meropenem |
| Predicate device: | MicroScan Dried Gram-Negative MIC/Combo Panels Meropenem - (K192355 |

## 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-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 additional indications for use. Acinetobacter species, with the MicroScan Dried Gram-Negative MIC/Combo Panel with meropenem 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. This Special Premarket Notification (510|k]) presents combined efficacy and challenge data in support of the addition for Acinetobacter species indications for use with MicroScan Dried Gram-Negative MC/Combo Panel with meropenem.

The external evaluations were conducted with fresh and stock Efficacy and Challenge isolates. The external evaluations were designed to confirm the acceptability of the proposed additional indications for use with the Dried Gram-Negative Panel by comparing its performance with a CLSI frozen Reference panel. The Dried Gram-Negative Panel inoculated with Prompt® and read on the WalkAway instrument demonstrated acceptable performance with Acinetobacter spp. Essential Agreement (EA) of 91.1% and Categorical Agreement (CA) of 98.2% for meropenem when compared with the frozen Reference panel.

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

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