The MicroScan® Synergies plus™ 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 enterococci and staphylococci. After inoculation, panels are incubated for 4.5 - 18 hours at 35℃ +/- 1℃, in a WalkAway® SI, or equivalent, and read by the MicroScan® Instrumentation. Additionally, the panels may be incubated in a non-CO2 incubator and the Antimicrobial Susceptibility Testing (AST) portions can be read visually, according to the Package Insert.

This particular submission is for the addition of the antimicrobial chloramphenicol, at concentrations of 4 to 16 µg/ml, for enterococci and staphylococci, to the test panel.

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

Staphylococcus aureus

Device Description

MicroScan® Synergies plus™ Gram-Positive MIC/Combo Panels, utilizing both the MicroScan® Rapid Fluorogenic Identification and Dried Overnight Antimicrobial Susceptibility Testing (AST) technologies, 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 enterococci and staphylococci.

The antimicrobial susceptibility tests are miniaturizations of the broth dilution susceptibility test that have been diluted in water and dehydrated. Various antimicrobial agents are diluted in water, buffer, or minute concentrations of broth, to concentrations bridging the range of clinical interest. Panels are rehydrated with Synergies plus™ Pos Broth, after inoculation with a standardized suspension of the organism. After incubation in the WalkAway® SI, or equivalent, System, for 4.5 -18 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 for the K063564 510(k) submission:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance (Chloramphenicol)
Substantially equivalent performance compared to a frozen Reference Panel, as defined in "Class II Special Controls Guidance Document: Antimicrobial Susceptibility Test (AST) Systems; Guidance for Industry and FDA", dated February 5, 2003.	Overall Categorical Agreement of 96.1% when compared with the frozen Reference panel.
Acceptable reproducibility and precision for chloramphenicol with Turbidity inoculum preparation method and the WalkAway® SI System or equivalent.	Demonstrated acceptable reproducibility and precision.
Acceptable Quality Control results for chloramphenicol.	Demonstrated acceptable results.

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

The text states: "The external validation was conducted with fresh and stock Efficacy isolates and stock Challenge strains." However, the exact number of isolates (sample size) used in the test set is not explicitly provided in the given text.

The data provenance is:

Country of Origin: Not explicitly stated, but the submission is to the US FDA.
Retrospective or Prospective: Not explicitly stated, but the phrase "external validation was conducted" suggests a prospective collection or evaluation against an existing reference. The use of "fresh" isolates implies a prospective component.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

The text mentions comparison to "Expected Results determined prior to the evaluation" for Challenge strains, and a "frozen Reference panel." This implies a pre-established ground truth, likely based on well-characterized strains and a reference method.

Number of Experts: The number of experts involved in establishing the ground truth for the reference panel or "Expected Results" is not explicitly stated.
Qualifications of Experts: The qualifications of any experts involved in establishing the ground truth are not explicitly stated. However, given the nature of antimicrobial susceptibility testing, it's implied that these would be microbiologists or clinical laboratory experts.

4. Adjudication Method for the Test Set

The text compares the device's performance directly to a "frozen Reference panel" and "Expected Results." This implies a direct comparison rather than an adjudication process among multiple readers or interpretations of the device's output. Therefore, an explicit adjudication method like "2+1" or "3+1" is not applicable or described in this context.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size

No, an MRMC comparative effectiveness study involving human readers and AI assistance was not done or described in this 510(k) summary. This device is an automated system for antimicrobial susceptibility testing, not an AI-assisted diagnostic tool for human interpretation of images or data.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Yes, this study is inherently a standalone performance evaluation of the MicroScan® Synergies plus™ Gram-Positive MIC/Combo Panel with chloramphenicol. The device, in conjunction with the WalkAway® SI system, automatically determines the MIC. The performance is compared to a reference standard (frozen reference panel), indicating an assessment of the algorithm's (or system's) output without direct human interpretation being the primary variable.

7. The Type of Ground Truth Used

The ground truth used is a "frozen Reference panel" and "Expected Results" for Challenge strains. This reference panel likely represents the established gold standard method for determining antimicrobial susceptibility, which would typically involve a recognized broth microdilution method read visually by experienced microbiologists or a calibrated instrument.

8. The Sample Size for the Training Set

The text does not provide any information about a specific "training set" or its sample size. This is typical for a traditional microbiology device validation, where the system is designed based on established principles, and then its performance is validated against reference methods, rather than being "trained" in the machine learning sense.

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

Since no training set is mentioned in the context of machine learning, the question of how its ground truth was established is not applicable here. The device's underlying principles are based on established microbiology methods, and its performance is validated against a reference standard.

Summary

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K063564

F-B 8 2007 510(k) Summary

510(k) Submission Information:

Device Manufacturer: Dade Behring Inc. Robert Eusebio, Regulatory Affairs Manager Contact name: 916-374-3144 Fax: Date prepared: November 13, 2006 Product Name: Microdilution Minimum Inhibitory Concentration (MIC) Panels MicroScan® Synergies plus™ Gram-Positive MIC/Combo Panels Trade Name: To determine antimicrobial agent susceptibility Intended Use: New antimicrobial - chloramphenicol 510(k) Notification: MicroScan® Synergies plus™ Gram-Negative MIC/Combo Predicate device: Panels and MicroScan® Dried Gram-Positive Panels

510(k) Summary:

The proposed MicroScan® Synergies plus™ Gram-Positive MIC/Combo Panel demonstrated substantially equivalent performance when compared with a 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 February 5, 2003. The Premarket Notification (510[k]) presents data in support of the MicroScan® Synergies plus™ Gram-Positive MIC/Combo Panel with chloramphenicol.

The external validation was conducted with fresh and stock Efficacy isolates and stock Challenge strains. The external validations were designed to confirm the acceptability of the proposed Synergies plus™ Gram-Positive Panel by comparing its performance with a frozen Reference panel. Challenge strains were compared to

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Expected Results determined prior to the evaluation. The Synergies plus™ Gram-Positive Panel demonstrated acceptable performance with an overall Categorical Agreement of 96.1% for chloramphenicol when compared with the frozen Reference panel.

Instrument reproducibility testing demonstrated acceptable reproducibility and precision for chloramphenicol with Turbidity inoculum preparation method and the WalkAway® SI System or equivalent.

Quality Control testing demonstrated acceptable results for chloramphenicol.

C 510k_a.doc 11/27/2006

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Image /page/2/Picture/0 description: The image shows the text "DEPARTMENT OF HEALTH & HUMAN SERVICES" in a bold, sans-serif font. The text is centered and appears to be the heading of a document or letter. The words are all capitalized and evenly spaced.

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Public Health Service

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Mr. Robert Eusebio Regulatory Affairs Manager Dade Behring, Inc. 2040 Enterprise Boulevard West Sacramento, CA 95691-9972

FEB 8 2007

Re: K063564 Trade/Device Name: MicroScan® Synergies plus™ Gram-Positive MIC/Combo Panels with Chloramphenicol (4 - 16 ug/ml) Regulation Number: 21 CFR 866.1645 Regulation Name: Fully automated short-term incubation cycle antimicrobial susceptibility system. Regulatory Class: Class II Product Code: LON Dated: November 27, 2006 Received: December 08, 2006

Dear Mr. Eusebio:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).

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This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial your device of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (240)276-0450. Also, please not the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll -free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.

Sincerely yours.

Sally, artman

Sally A. Hojvat, M.Sc., Ph.D. Director Division of Microbiology Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known): K063564

Device Name: MicroScan® Synergies plus™ Gram-Positive MIC/Combo Panels with Chloramphenicol (4 - 16 ug/ml)

Indications For Use:

This particular submission is for the addition of the antimicrobial chloramphenicol, at concentrations of 4 to 16 µg/ml, for enterococci and staphylococci, to the test panel.

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

Staphylococcus aureus

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Freddie Lee. Poole

Sion Sicamill

Office of In Vitro Diagnostic Device Evelophand Sacry

510(k) K063564

Page 1 of

C 510k a.doc 11/27/2006

Regulation Number and Section

§ 866.1645 Fully automated short-term incubation cycle antimicrobial susceptibility system.

(a)
Identification. A fully automated short-term incubation cycle antimicrobial susceptibility system is a device that incorporates concentrations of antimicrobial agents into a system for the purpose of determining in vitro susceptibility of bacterial pathogens isolated from clinical specimens. Test results obtained from short-term (less than 16 hours) incubation are used to determine the antimicrobial agent of choice to treat bacterial diseases.(b)
Classification. Class II (special controls). The special control for this device is FDA's guidance document entitled “Class II Special Controls Guidance Document: Antimicrobial Susceptibility Test (AST) Systems; Guidance for Industry and FDA.”