The MicroScan® Dried Gram-Positive 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-positive bacteria. 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 reformulated antimicrobial Vancomycin at concentrations of 0.25 to 64 ug/ml to the test panel.

The gram-positive organisms which may be used for Vancomycin susceptibility testing in this panel are:

Enterococci (e.g., Enterococcus faecalis)

Staphylococci, including Staphylococcus aureus and Staphylococcus epidermidis (including heterogeneous methicillinresistant strains)

Device Description

MicroScan Dried Gram-Positive 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-positive bacteria.

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 breakdown of the acceptance criteria and study details based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Performance Metric	Acceptance Criteria (Stated or Implied)	Reported Device Performance
Essential Agreement (EA)	Not explicitly stated, but high (e.g., >90%)	Ranged from 97.6% to 99.0% for Enterococcus spp.
Reproducibility	"Acceptable reproducibility and precision"	Demonstrated acceptable reproducibility and precision with vancomycin.
Quality Control (QC)	"Acceptable results"	Demonstrated acceptable results for vancomycin.

2. Sample Size and Data Provenance

Test Set Sample Size:
- The document mentions "fresh and stock Efficacy isolates and stock Challenge strains" and "Reproducibility isolates." Specific numerical sample sizes for each of these categories are not provided.
- The Essential Agreement figures are reported for Enterococcus spp. but the total number of isolates tested to achieve these percentages is not given.
Data Provenance: The text does not specify the country of origin of the data. The study involved a reevaluation of clinical evaluation data. It is a retrospective analysis of existing data combined with new testing for reproducibility and quality control.

3. Number of Experts and Qualifications

Number of Experts: Not specified.
Qualifications of Experts: Not specified. The document refers to "CLSI frozen Reference Panel" as a comparator, implying that the ground truth was established using standard clinical laboratory methods, likely by trained microbiologists, but explicit details are missing.

4. Adjudication Method

Adjudication Method: Not specified. The comparison is made against a "CLSI frozen Reference Panel," which acts as the reference standard. There is no mention of multiple experts independently reading and then adjudicating discrepancies.

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

MRMC Study Done: No, an MRMC comparative effectiveness study was not done. This device is an automated antimicrobial susceptibility test (AST) system, not a diagnostic imaging device that typically involves human readers. The comparison is between the device's performance and a reference standard.
Effect Size of Human Readers Improvement: Not applicable, as this was not an MRMC study.

6. Standalone Performance (Algorithm Only)

Standalone Performance: Yes, the study evaluates the standalone performance of the MicroScan Dried Gram-Positive MIC/Combo Panel. It compares the panel's results (read either visually or with MicroScan instrumentation) against a CLSI frozen Reference Panel. The "MicroScan instrumentation" represents the automated component of the device's performance.

7. Type of Ground Truth Used

Type of Ground Truth: The ground truth was established by a CLSI frozen Reference Panel. This is a recognized reference method for antimicrobial susceptibility testing, providing a reliable standard against which the device's performance can be measured.

8. Sample Size for the Training Set

Training Set Sample Size: The document does not explicitly mention a "training set" or its size. The study described is a validation study comparing the modified panel's performance against a reference standard. If machine learning or AI was used in the panel's development, information about its training set would typically be separate from this validation study. However, the core technology described (microdilution MIC panels) is a biochemical testing method, not typically an AI/machine learning application requiring an explicit "training set" in the sense of AI models.

9. How Ground Truth for Training Set Was Established

Ground Truth for Training Set: Not applicable/not provided. As noted above, the document doesn't detail a separate training set for an AI/machine learning model. For traditional AST panels like this, the "ground truth" for developing and calibrating the panel's concentrations and reading parameters would have been established through extensive microbiological research and correlation with clinical outcomes, usually against reference methods like broth microdilution, which is foundational to CLSI standards.

Summary

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

September 16, 2015

BECKMAN COULTER, INC. SHANNON POPSON STAFF REGULATORY AFFAIRS 1584 ENTERPRISE BLVD. WEST SACRAMENTO CA 95691

Re: K152346

Trade/Device Name: MicroScan Dried Gram Positive Mic/combo Panels - Vancomvcin (0.25-64 ug/ml) Regulation Number: 21 CFR 866.1640 Regulation Name: Antimicrobial susceptibility test powder Regulatory Class: II Product Code: JWY, LRG, LTT, LTW Dated: August 19, 2015 Received: August 20, 2015

Dear Ms. 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 Parts 801 and 809); medical device reporting (reporting of medical device-related adverse events) (21 CFR 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.

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If you desire specific advice for your device on our labeling regulations (21 CFR Parts 801 and 809), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

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) K152346

Device Name

MicroScan Dried Gram-Positive MIC/Combo Panels with Vancomycin (0.25 - 64 µg/ml)

Indications for Use (Describe)

This particular submission is for the reformulated antimicrobial Vancomycin at concentrations of 0.25 to 64 ug/ml to the test panel.

The gram-positive organisms which may be used for Vancomycin susceptibility testing in this panel are:

Enterococci (e.g., Enterococcus faecalis)

Staphylococci, including Staphylococcus aureus and Staphylococcus epidermidis (including heterogeneous methicillinresistant strains)

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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510(k) Summary

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:	September 15, 2015
Product Name:	Microdilution Minimum Inhibitory Concentration (MIC) Panels
Trade Name:µg/ml)	MicroScan® Dried Gram-Positive MIC/Combo Panels -Vancomycin (0.25 – 64
Intended Use:	To determine antimicrobial agent susceptibility
Classification:	Class II
Product Code:	LTT
510(k) Notification:	Antimicrobial agent - Vancomycin
Predicate device:	MicroScan Dried Gram-Positive MIC/Combo Panels - Vancomycin (K150039)

510(k) Summary:

The modified MicroScan Dried Gram-Positive 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 Special Premarket Notification (510[K]) presents data in support of the MicroScan Dried Gram-Positive MIC/Combo Panel with vancomycin which includes an reduced incubation time of 16-20 hours for Enterococci isolates.

The validation study was conducted by reevaluating the clinical evaluation data which utilized fresh and stock Efficacy isolates and stock Challenge strains. Efficacy, Challenge and Reproducibility isolates were evaluated using all inoculation and reading methods. The study was designed to confirm the acceptability of the proposed Dried Gram-Positive Panel by comparing its performance with a CLSI frozen Reference panel. Challenge strains were compared to a frozen Reference panel result collected as a matched pair. The Essential Agreement of the Dried Gram Positive Panel when testing Enterococcus spp. ranged from 97.6% to 99.0% using the various inoculum preparation and reading methods.

Inoculum and instrument reproducibility testing demonstrated acceptable reproducibility and precision with vancomycin, regardless of which inoculum method (i.e., Turbidity and Prompt™), or instrument (autoSCAN-4 and WalkAway) was used.

Quality Control testing demonstrated acceptable results for vancomycin.

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).