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 ciprofloxacin (Cp-S) at concentrations of 0.004 to 8 µg/ mL to the test panel.

The gram-negative organism which may be used for ciprofloxacin susceptibility testing on this panel is:

Salmonella Typhi

Device Description

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.

AI/ML Overview

Here's a summary of the acceptance criteria and the study details for the MicroScan Dried Gram-Negative MIC/Combo Panels with Ciprofloxacin-S based on the provided FDA 510(k) summary:

Device: MicroScan Dried Gram-Negative MIC/Combo Panels with Ciprofloxacin-S (0.004 - 8 µg/mL)
Intended Use: 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. Specifically, this submission is for the antimicrobial ciprofloxacin (Cp-S) at concentrations of 0.004 to 8 µg/mL for the organism Salmonella Typhi.

1. Table of Acceptance Criteria and Reported Device Performance

The provided document does not explicitly state numerical acceptance criteria for "Essential Agreement" in a formal table format with specific thresholds. However, it indicates that the device demonstrated "acceptable performance" and details the "Essential Agreement" obtained.

Criterion Type	Acceptance Criteria (Implicit from "acceptable performance")	Reported Device Performance (for Ciprofloxacin-S and Salmonella Typhi)
Essential Agreement	Acceptable performance when compared with a CLSI frozen Reference Panel, as defined in "Class II Special Controls Guidance Document: Antimicrobial Susceptibility Test (AST) Systems; Guidance for Industry and FDA", dated August 28, 2009.	100% Essential Agreement
Reproducibility & Precision	Acceptable reproducibility and precision for ciprofloxacin across different inoculum methods and instruments.	Demonstrated acceptable reproducibility and precision.
Quality Control	Acceptable results for ciprofloxacin in quality control testing.	Demonstrated acceptable results.

2. Sample Size Used for the Test Set and Data Provenance

Test Set Organism: The specific organism mentioned for testing in this submission is Salmonella Typhi. The document refers to "stock Challenge strains" for the external evaluation.
Sample Size: The document does not specify the exact number of Salmonella Typhi isolates or challenges strains used in the test set. It mentions "external evaluation was conducted with stock Challenge strains."
Data Provenance: Not explicitly stated (e.g., country of origin, retrospective/prospective). However, the use of "stock Challenge strains" implies a controlled laboratory setting, which is typical for in vitro diagnostic device evaluations.

3. Number of Experts and Qualifications for Ground Truth

The document does not mention the use of human experts to establish ground truth for the test set.
Ground Truth Method: The ground truth for antimicrobial susceptibility testing (in vitro diagnostic devices) is typically established by using a CLSI frozen Reference Panel. This standardized method eliminates the need for human expert consensus on individual results because the reference method itself serves as the gold standard for comparison.

4. Adjudication Method for the Test Set

Not applicable as the ground truth is established by a standardized reference method (CLSI frozen Reference Panel), not by human expert review requiring adjudication.

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

No, an MRMC study was not conducted. This type of study (AI assistance for human readers) is not relevant for an in vitro diagnostic device like an antimicrobial susceptibility test panel, which determines susceptibility directly. The device itself is the primary determinant of the result, not an aid to human interpretation of images or complex data as seen in AI imaging applications.

6. Standalone (Algorithm Only) Performance

Yes, a standalone performance evaluation was done. The entire study described is a standalone evaluation of the device's ability to accurately determine antimicrobial susceptibility concentrations when compared against a recognized reference method (CLSI frozen Reference Panel). The "Essential Agreement" reported is a measure of this standalone performance.

7. Type of Ground Truth Used

CLSI frozen Reference Panel: This is the established "gold standard" reference method for antimicrobial susceptibility testing, providing the ground truth for comparison.

8. Sample Size for the Training Set

The document does not specify a separate training set or its sample size. For in vitro diagnostic devices based on chemical reactions (like MIC panels), there isn't typically a "training set" in the machine learning sense. The device's performance is inherently based on its chemical design and manufacturing, which is validated through performance studies as described.

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

Not applicable, as there is no mention of a traditional "training set" and its ground truth in the context of this device. The development of such panels relies on established microbiological principles and validated manufacturing processes to ensure the correct antimicrobial concentrations are present in each well.

Summary

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December 7, 2017

Beckman Coulter Inc. Shannon Popson Staff Regulatory Affairs 2040 Enterprise Blvd West Sacramento, California 95691

Re: K172912

Trade/Device Name: MicroScan Dried Gram-Negative MIC/Combo Panels with Ciprofloxacin-S (0.004 - 8 µg/mL) Regulation Number: 21 CFR 866.1640 Regulation Name: Antimicrobial susceptibility test powder Regulatory Class: Class II Product Code: LTT, JWY, LRG, LTW Dated: September 22, 2017 Received: September 25, 2017

Dear Shannon 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

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803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR 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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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) K172912

Device Name

MicroScan Dried Gram-Negative MIC/Combo Panels with Ciprofloxacin-S (0.004-8 ug/mL)

Indications for Use (Describe)

This particular submission is for the antimicrobial ciprofloxacin (Cp-S) at concentrations of 0.004 to 8 µg/ mL to the test panel.

The gram-negative organism which may be used for ciprofloxacin susceptibility testing on this panel is:

Salmonella Typhi

Type of Use (Select one or both, as applicable)
-------------------------------------------------

X Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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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:	December 6, 2017
Product Name:	Microdilution Minimum Inhibitory Concentration (MIC) Panels
Trade Name:	MicroScan Dried Gram-Negative MIC/Combo Panels with Ciprofloxacin-S (0.004 - 8µg/mL)
Intended Use:	To determine antimicrobial agent susceptibility
Classification:	Class II
Product Code:	LTT
510(k) Notification:	Antimicrobial agent - ciprofloxacin
Predicate device:	MicroScan Dried Gram Negative MIC/Combo Panels - Imipenem (K162740)

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 ciprofloxacin.

The external evaluation was conducted with stock Challenge strains. The external evaluation was 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 Essential Agreement of 100% for Ciprofloxacin-S and Salmonella Typhi when compared with the frozen Reference panel.

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

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 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).