SYNERGIES PLUS GRAM-POSITIVE MIC/COMBO PANELS by DADE BEHRING, INC.

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°C +/- 1°C, 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 oxacillin, at concentrations of 0.03 to 8 ug/ml Long Dilution Sequence for S. aureus and S. lugdunensis, and 0.03 - 2 ug/ml 7-Dilution MIC Dilution Sequence, and 0.12 -- 2 ug/ml 5-Dilution Breakpoint Sequence, for all Staphylococcus species, to the test panel.

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

. Staphylococcus species

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 Synergics plus" Pos Broth, after inoculation with a standardized suspension of the organism. After incubation in the WalkAway® SI, or equivalent, 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

The provided document describes the 510(k) submission for the MicroScan® Synergies plus™ Gram-Positive MIC/Combo Panels with the addition of oxacillin, intended for antimicrobial susceptibility testing.

Here's an analysis based on your requested information:

1. Table of Acceptance Criteria and Reported Device Performance

Parameter	Acceptance Criteria (Implicit for AST systems per FDA guidance)	Reported Device Performance (Essential Agreement)
Overall Essential Agreement	Not explicitly stated but typically 90% or higher	97.1%

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

Sample Size: Not explicitly stated as a number. The study mentions "fresh and stock Efficacy isolates and stock Challenge strains." However, the exact count of isolates and strains used for external validation is not provided.
Data Provenance: The document does not specify the country of origin. It indicates the study was an "external validation."
Retrospective or Prospective: Retrospective, as "stock Efficacy isolates and stock Challenge strains" are used, implying pre-existing samples.

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

This information is not provided in the document. The reference panel is described as a "frozen Reference Panel" and "Expected Results," but the process for establishing the ground truth for this reference is not detailed.

4. Adjudication Method for the Test Set

This information is not provided in the document. The comparison is made against a "frozen Reference Panel" and "Expected Results," which implies a single, established ground truth rather than a process requiring adjudication among multiple experts for the test set.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No, an MRMC comparative effectiveness study was not done. This study focuses on the performance of an automated system (MicroScan® Synergies plus™ panels) compared to a reference method, not on human reader performance with or without AI assistance. The document mentions that the AST portions can be read visually, but the primary validation is for the automated instrument reading.

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

Yes, a standalone performance evaluation was done. The study explicitly states that the "MicroScan® Synergies plus™ Gram-Positive MIC/Combo Panel demonstrated substantially equivalent performance when compared with a frozen Reference Panel." The assessment is of the device's ability to determine susceptibility, which is an automated measurement, even though visual reading is also possible.

7. The Type of Ground Truth Used

The ground truth was established by a "frozen Reference Panel" and "Expected Results." For antimicrobial susceptibility testing (AST) systems, this typically involves a standardized reference broth microdilution method, which is considered the gold standard.

8. The Sample Size for the Training Set

The document does not provide information regarding a separate training set. The study focuses on "external validation" with "fresh and stock Efficacy isolates and stock Challenge strains," which serve as the test set. For AST systems, the "training" aspect is more about the development and optimization of the panel's design and interpretation rules, often involving a large internal collection of characterized strains, rather than a distinct "training set" in the machine learning sense for the final validation study.

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

As no specific training set is detailed, the method for establishing its ground truth is not provided. If an internal development set was used, its ground truth would have likely been established through similar reference methods as the validation set.

Summary

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K07/076

510(k) Summary

MAY 2 1 2007

510(k) Submission Information:
Device Manufacturer: Dade Behring Inc.
Contact name: Robert Eusebio, Regulatory Affairs Manager
Fax: 916-374-3144
Date prepared:	April 10, 2007
Product Name:	Microdilution Minimum Inhibitory Concentration (MIC) Panels
Trade Name:	MicroScan® Synergies plus™ Gram-Positive MIC/Combo Panels
Intended Use:	To determine antimicrobial agent susceptibility
510(k) Notification:	New antimicrobial agent - oxacillin
Predicate device:	MicroScan® Synergies plus™ Gram-Negative MIC/Combo Panels andMicroScan® 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 Tcst (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 oxacillin.

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 Expected Results determined prior to the evaluation. The Synergies plus" Gram-Positive Panel demonstrated acceptable performance with an overall Essential Agreement of 97.1%, for the 7-Dilution Sequence (which includes all Staphylococcus species) when compared with the frozen Reference panel and Expected Results.

Ox 510k.doc 4/12/2007

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

Quality Control testing demonstrated acceptable results for the MicroScan® Synergies plus™ Gram-Positive MIC/Combo Panel with oxacillin.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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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

MAY 2 1 2007

Re: K071076

Trade/Device Name: MicroScan® Synergies plus ™ Gram-Positive MIC/Combo Panels with oxacillin (0.03 - 8 ug/ml Long Dilution Sequence, 0.03 - 2 ug/ml 7 Dilution MIC Sequence and 0.12 - 2 ug/ml 5 Dilution Breakpoint Sequence) Regulation Number: 21 CFR § 866.1645 Regulation Name: Antimicrobial Susceptibility Test Powder Regulatory Class: II Product Code: LON, LRG, LTT, LWY Dated: April 13, 2007 Received: April 16, 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 (OS) 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 equivalence 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 note 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 attorn

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): KO U0 7/0

Device Name: MicroScan® Synergies plus™ Gram-Positive MIC/Combo Panels with oxacillin (0.03 - 8 ug/ml Long Dilution Sequence, 0.03 - 2 ug/ml 7-Dilution MIC Sequence and 0.12 - 2 ug/ml 5-Dilution Breakpoint Sequence)

Indications For Use:

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

. Staphylococcus species

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)

Luddie M. Poole

KO71076

Division Sign-Off

510(k)_

Office of In Vitro Diagnostic Device Evaluation and Safety

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Ox 510k.doc 4/12/2007

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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.”