MicroScan® Synergies plus™ 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 (Enterobacteriaceae, glucose nonfermenters, and non-Enterobacteriaceae glucose fermenters. After inoculation, panels are read on the WalkAway® S7 System or equivalent (upgraded WalkAway® 40 or WalkAway® 96) according to the Package Insert.

This particular submission is for the antimicrobial Gatifloxacin on the Synergies plus" Gram-Negative MIC/Combo Panels.

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

Escherichia coli Klebsiella pneumoniae Proteus mirabilis Acinetobacter lwoffii Citrobacter koseri Proteus vulgaris

Citrobacter freundii Enterobacter aerogenes Enterobacter cloacae Klebsiella oxytoca Morganella morganii

Device Description

MicroScan rapID/S plus ™ Gram-Negative 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 MicroScan rapID/S plus ™ Gram-Negative MIC/Combo Panels are read on the WalkAway SI System or equivalent (upgraded WalkAway® 40 or WalkAway® 96 instruments).

The antimicrobial susceptibility tests are miniaturizations of the broth dilution susceptibility test that have been diluted in Mueller-Hinton Broth to concentrations bridging the range of clinical interest and are presented in micro-titer wells in dried form. rapID/S plus ™ panels are inoculated and rehydrated with a standardized suspension of the organism and incubated at 35℃ in the WalkAway® SI System or equivalent for 4.5 - 18 hours. The minimum inhibitory concentration (MIC) for the test organism is determined by the lowest antimicrobial concentration showing inhibition of growth.

AI/ML Overview

The provided text describes the 510(k) summary for the MicroScan® Synergies Plus Gram-Negative MIC/Combo Panels with Gatifloxacin (0.004 - 16 ug/ml). This device is used to determine the susceptibility of Gram-Negative bacilli to antimicrobial agents. The information below is extracted from the provided text to answer your questions.

1. A table of acceptance criteria and the reported device performance

The provided summary mentions the device's performance compared to an NCCLS frozen Reference Panel. While explicit "acceptance criteria" are not numerically stated as such, the "acceptable performance" is defined by the following agreement percentages:

Metric	Acceptance Criteria (Implied as "acceptable performance")	Reported Device Performance
Essential Agreement	Acceptable Performance (Specific % not given as a threshold, but 98.8% achieved)	98.8% (399/404)
Categorical Agreement	Acceptable Performance (Specific % not given as a threshold, but 96.5% achieved)	96.5% (306/317)

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Test Set Sample Size:
- Essential Agreement: 404 isolates tested (presumably 404 comparisons).
- Categorical Agreement: 317 isolates tested (presumably 317 comparisons).
Data Provenance: The document states "The external evaluation was conducted with fresh and stock Efficacy isolates and stock Challenge strains." This suggests a combination of prospective (fresh isolates) and retrospective (stock isolates/strains) data. The country of origin is not specified, but the submission is to the U.S. FDA.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not provided in the given text. The ground truth was established by an "NCCLS frozen Reference panel," but details about the experts or their qualifications for establishing this reference are not mentioned.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not provided in the given text. The comparison was made against an NCCLS frozen Reference panel, but how that panel's results were adjudicated is not detailed.

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

MRMC Study: No, a multi-reader multi-case (MRMC) comparative effectiveness study was not conducted. This device is an automated system for determining antimicrobial susceptibility, not an AI-assisted diagnostic tool for human readers.
Effect Size: Not applicable, as no MRMC study was performed involving human readers and AI assistance.

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

Yes, a standalone performance evaluation was done. The "MicroScan® Synergies Plus Gram-Negative MIC/Combo Panels with Gatifloxacin" is an automated system that provides the Minimum Inhibitory Concentration (MIC) for test organisms. The evaluation compared the device's results directly against an "NCCLS frozen Reference panel" to assess its accuracy. The text describes the device's performance as an algorithm/system generating results directly.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The ground truth used was the results obtained from an NCCLS frozen Reference Panel. This panel represents a standardized and accepted method for determining antimicrobial susceptibility, likely established through rigorous laboratory procedures and potentially expert consensus on those methods.

8. The sample size for the training set

The text does not specify a separate "training set" or its sample size. The description focuses on the external evaluation (test set) and quality control. For such an automated system relying on established biochemical reactions, the "training" might be inherent in the manufacturing and calibration processes rather than a distinct machine learning-style training set of data.

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

As no specific training set is mentioned, information on how its ground truth was established is not provided in the text.

Summary

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Image /page/0/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged in a circular pattern around the symbol. The logo is black and white.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

AUG 3 0 2004

Mr. Robert Eusebio Manager Regulatory Affairs Dade MicroScan, Inc. 1584 Enterprise Boulevard West Sacramento, CA 95691

Re: K023361 Trade/Device Name: MicroScan® Synergies Plus Gram Negative MIC/Combo Panels With Gatifloxacin (0.004 - 16 ug/ml) Regulation Number: 21 CFR 866.1645 Regulation Name: Fully Automated Short-Term Incubation Cycle Antimicrobial Susceptibility System Regulatory Class: II Product Code: LON Dated: July 30, 2004 Received: August 3, 2004

Dear Mr. Eusebio:

This letter corrects our substantially equivalent letter of December 16, 2002, regarding the trade name which was changed to MicroScan® Synergies Plus to better reflect the intended use of the device.

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 (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 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.

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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); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (sections 531-542 of the Act); 21 CFR 1000-1050.

This letter will allow you to continue 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 and additionally Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-3084. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at their toll free number (800) 638-2041 or at (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.

Sincerely yours,

Fuddie Lu. Pate
fo

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 Statement

510(k) Number (if known): K023361

Device Name: MicroScan® Synergies plus " Gram-Negative MIC/Combo Panels with Gatifloxacin

(0.004 – 16 µg/ml)

Indications For Use:

This particular submission is for the antimicrobial Gatifloxacin on the
Synergies plus" Gram-Negative MIC/Combo Panels.

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

Escherichia coli Klebsiella pneumoniae Proteus mirabilis Acinetobacter lwoffii Citrobacter koseri Proteus vulgaris

Citrobacter freundii Enterobacter aerogenes Enterobacter cloacae Klebsiella oxytoca Morganella morganii

Prescription Use (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)

Fredda W. Cole
Division Sign-Off

Office of In Vitro Diagnostic Device Evaluation and Safety

Page 1 of _ 1

510(k) K023361

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510(k) Summary

DEC 1 6 2002

510(k) Submission Information:

Device Manufacturer:	Dade Behring Inc.
Contact name:	Cynthia Van Duker, Manager Regulatory Affairs
Fax:	916-374-3144
Date prepared:	October 3, 2002
Product Name:	Microdilution Minimum Inhibitory Concentration (MIC) Panels
Trade Name:	MicroScan rapID/S plus™ Gram-Negative MIC/Combo panels
Intended Use:	To determine antimicrobial agent susceptibility
510(k) Notification:	Antimicrobials: Gatifloxacin
Predicate device:	MicroScan Dried Gram Negative MIC/Combo Panels

510(k) Summary:

The proposed MicroScan rapID/S plus™ Gram-Negative MIC/Combo Panel demonstrated substantially equivalent performance when compared with an NCCLS frozen Reference Panel, as defined in the FDA DRAFT document "Guidance on Review Criteria for Assessment of Antimicrobial Susceptibility Devices", dated March 8, 2000. The Premarket Notification (510[k]) presents data in support of the MicroScan® rapID/S plus™ Gram-Negative MIC/Combo Panel with Gatifloxacin.

The external evaluation was conducted with fresh and stock Efficacy isolates and stock Challenge strains. The external evaluations were designed to confirm the acceptability of the proposed rapID/S plus ™ Gram-Negative Panel by comparing its performance with an NCCLS frozen Reference panel. Challenge strains were compared to Frozen Results determined prior to the evaluation. The rapID/S plus ™ Gram-Negative Panel demonstrated acceptable performance with an overall Essential Agreement of 98.8% (399/404) and Categorical Agreement of 96.5% (306/317) compared with the frozen Reference panel.

Instrument reproducibility testing demonstrated acceptable reproducibility and precision with Gatifloxacin with Turbidity inoculum preparation method and the WalkAway® SY System or equivalent (upgraded WalkAway® 40 or WalkAway® 96 instruments).

Quality Control testing demonstrated acceptable results for Gatifloxacin.

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.”