MICROSCAN SYNERGIES PLUS GRAM POSITIVE MIC/COMBO PANELS NEW ANTIMICROBIAL-STREPTOMYCIN SYNERGY SCREEN 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℃ +/- 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 Streptomycin Synergy Screen, at a concentration of 1000 ug/ml, for enterococci, to the test panel.

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

Enterococcus 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 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 information for the MicroScan® Synergies plus™ Gram-Positive MIC/Combo Panels with Streptomycin Synergy Screen, based on the provided text:

Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Substantially equivalent performance compared to 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.	Overall Categorical Agreement of 98.4% for Streptomycin Synergy Screen when compared with the frozen Reference panel.
Acceptable reproducibility and precision for Streptomycin Synergy Screen.	Demonstrated acceptable reproducibility and precision with Turbidity inoculum preparation method and the WalkAway® SI System or equivalent.
Acceptable Quality Control testing results for Streptomycin Synergy Screen.	Demonstrated acceptable results for Streptomycin Synergy Screen.

Study Information

2. Sample size used for the test set and the data provenance:

Test Set Description: The external validation was conducted with "fresh and stock Efficacy isolates and stock Challenge strains."
Sample Size: The exact numerical sample size for the test set is not specified in the provided text.
Data Provenance: The text does not explicitly state the country of origin. It indicates "external validation," which could imply data collected from various geographical locations or a specific external site. The study seems to be prospective in nature for the "fresh" isolates, and potentially retrospective for the "stock" isolates and challenge strains.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

The text does not specify the number of experts or their qualifications used to establish the ground truth for the test set.

4. Adjudication method for the test set:

The text does not describe any specific adjudication method used for the test set. It mentions "Challenge strains were compared to Expected Results determined prior to the evaluation," implying a pre-defined ground truth for these strains, but not an adjudication process for discrepancies.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

No, an MRMC comparative effectiveness study was not done. This device (antimicrobial susceptibility test panel) is a diagnostic assay, not an AI-assisted reading tool for human interpretation of images or other complex data.

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

Yes, it was a standalone performance study. The device is designed to provide quantitative and/or qualitative antimicrobial agent susceptibility directly by determining the lowest antimicrobial concentration showing inhibition of growth after incubation. While human intervention is involved in preparing the inoculum and reading (or setting up an instrument to read), the core performance measurement (Categorical Agreement) is against a reference method. The text mentions "the minimum inhibitory concentration (MIC) for the test organism is read by determining the lowest antimicrobial concentration showing inhibition of growth," and this reading can be done by the WalkAway® SI system or equivalent, indicating an automated or semi-automated standalone nature for the reading part.

7. The type of ground truth used:

The ground truth was established by a frozen Reference Panel. For the challenge strains, "Expected Results" were determined prior to the evaluation, which would likely be derived from a validated reference method.

8. The sample size for the training set:

The text does not mention a training set sample size. This type of device (a diagnostic panel) typically undergoes R&D and validation but not in the same "training set" manner as machine learning algorithms.

9. How the ground truth for the training set was established:

As a training set is not explicitly mentioned or applicable in the traditional sense for this type of device, the method for establishing its ground truth is not described. The "frozen Reference Panel" is used for validation/testing, not for training.

Summary

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K0713/6

AUE 2 0 2007

510(k) Submission Information:

Device Manufacturer: Dade Behring Inc. Contact name: Robert Eusebio, Regulatory Affairs Manager 916-374-3144 Fax: Date prepared: May 4, 2007 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 - Streptomycin Synergy Screen 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 Streptomycin Synergy Screen.

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 Categorical

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Agreement of 98.4% for Streptomycin Synergy Screen when compared with the frozen Reference panel.

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

Quality Control testing demonstrated acceptable results for Streptomycin Synergy Screen.

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Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Mr. Robert Eusebio Regulatory Affairs Specialist Dade Behring, Inc. 2040 Enterprise Blvd West Sacramento, CA 95691

Re: K071316

Trade/Device Name: MicroScan® Synergies plus™ Gram-Positive MIC/Combo Panels with Streptomycin Synergy Screen (1000 µg/ml) Regulation Number: 21 CFR 866.1645 Regulation Name: Fully Automated Short Term Incubation Cycle Antimicrobial Susceptibility Device Regulatory Class: Class II Product Code: LRG, JWY, LTT Dated: May 9, 2007 Received: August 7, 2007

AUG 2 0 2007

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 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 advice for your device on our labeling regulation (21 CFR Part 801), 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). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Sally attaym

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): KO74316/S |

Device Name: MicroScan® Synergies plus™ Gram-Positive MIC/Combo Panels with Streptomycin Synergy Screen (1000 ug/ml)

Indications For Use:

This particular submission is for the addition of the antimicrobial Streptomycin Synergy Screen, at a concentration of 1000 ug/ml, for enterococci, to the test panel.

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

Enterococcus 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)

Freddie L. Poole
Division Sign-Off

Division Sign-Off

Office of In Vitro Diagnostic Device Evaluation and Safety

1071316 510(k)_

510(k) Summary

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).