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.

AI/ML Overview

The provided document describes the 510(k) summary for Beckman Coulter's MicroScan Dried Gram-Negative MIC/Combo Panels with Meropenem, a device used to determine antimicrobial agent susceptibility.

Here's an analysis of the acceptance criteria and study details:

1. Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Acceptance Criteria (as per FDA Guidance "Class II Special Controls Guidance Document: Antimicrobial Susceptibility Test (AST) Systems; Guidance for Industry and FDA", dated August 28, 2009)	Reported Device Performance
Essential Agreement (EA)	Not explicitly stated in the provided text, but generally, for AST devices, EA is expected to be ≥ 90%.	Enterobacteriaceae: 95.5%
		Pseudomonas aeruginosa: 93.1%
Categorical Agreement (CA)	Not explicitly stated in the provided text, but generally, for AST devices, CA is expected to be ≥ 90%.	Enterobacteriaceae: 98.8%
		Pseudomonas aeruginosa: 92.4%
Reproducibility and Precision	Acceptable reproducibility and precision	Demonstrated acceptable reproducibility and precision with meropenem, regardless of inoculum method (Turbidity or Prompt) or instrument (autoSCAN-4 or WalkAway).
Quality Control (QC)	Acceptable QC results	Demonstrated acceptable results for meropenem.

The device demonstrated acceptable performance by meeting the (unstated, but implied typical) thresholds for Essential Agreement and Categorical Agreement, as well as showing acceptable reproducibility and quality control.

2. Sample Size and Data Provenance

The document does not explicitly state the exact sample sizes for the test set. However, it indicates:

"The external evaluations were conducted with fresh, recent and stock Efficacy isolates and stock Challenge strains."
Data Provenance: The document does not specify the country of origin. The study was retrospective as it used "stock Efficacy isolates and stock Challenge strains" implying pre-existing samples. "Fresh, recent" isolates suggest some prospective collection, but the overall context of "external evaluations designed to confirm" typically refers to testing against a well-characterized panel.

3. Number of Experts and Qualifications

The document does not provide information on the number of experts used or their qualifications for establishing the ground truth.

4. Adjudication Method

The document does not specify an adjudication method.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not conducted or described. The study focuses on comparing the device's performance against a CLSI frozen Reference Panel, not on human reader performance with or without AI assistance.

6. Standalone (Algorithm Only) Performance Study

Yes, a standalone study was conducted. The "Dried Gram-Negative Panel inoculated with Prompt® and read on the WalkAway instrument demonstrated acceptable performance" compared to the CLSI frozen Reference Panel. This describes the performance of the device (algorithm/system) itself without human interpretation as the primary endpoint beyond the initial setup.

7. Type of Ground Truth Used

The ground truth used was a CLSI frozen Reference Panel. This is a standardized and well-characterized panel typically used for evaluating antimicrobial susceptibility test systems, representing a robust and accepted form of ground truth in this field.

8. Sample Size for the Training Set

The document does not provide any information about the sample size for a training set. This is typical for submissions focused on the validation of an in-vitro diagnostic device against a reference method, rather than the development of a novel algorithm through machine learning, where training sets are usually discussed.

9. How the Ground Truth for the Training Set Was Established

As no training set is mentioned (see point 8), there is no information on how its ground truth would have been established. The focus is solely on the performance against the CLSI frozen Reference Panel during evaluation.

Summary

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the text "FDA U.S. FOOD & DRUG ADMINISTRATION" on the right. The symbol on the left is a stylized image of a human figure, and the text on the right is in blue. The text is arranged in three lines, with "FDA" on the first line, "U.S. FOOD & DRUG" on the second line, and "ADMINISTRATION" on the third line.

November 14, 2019

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

Re: K192355

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: JWY, LTT, LRG, LTW Dated: August 28, 2019 Received: August 29, 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

{1}------------------------------------------------

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 (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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

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/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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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

{2}------------------------------------------------

Image /page/2/Picture/0 description: The image shows the logo for Beckman Coulter. The logo consists of a red circular symbol on the left, followed by the company name "BECKMAN COULTER" in bold, black font. The symbol appears to be a stylized representation of two curved shapes within the circle.

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:	August 23, 2019
Product Name:	Microdilution Minimum Inhibitory Concentration (MIC) Panels
Trade Name:	MicroScan Dried Gram-Negative MIC/Combo Panels with Meropenem (Mer) (0.004 -32 µg/mL)
Intended Use:	To determine antimicrobial agent susceptibility
Classification:	Class II
Product Code:	LTT
510(k) Notification:	Updated Breakpoints - Meropenem
Predicate device:	MicroScan Dried Gram-Negative MIC/Combo Panels Eravacycline - (K190109)

510(k) Summary:

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 meropenem.

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 inculated with Prompt® and read on the WalkAway instrument demonstrated acceptable performance with an Enterobacteriaceae Essential Agreement (EA) of 95.5% and Categorical Agreement (CA) of 98.8%, and Pseudomonas aeruginosa EA of 93.1% and CA of 92.4% 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.

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.

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

Regulation Number and Section

§ 866.1640 Antimicrobial susceptibility test powder.

(a)
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.(b)
Classification. Class II (performance standards).