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

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

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

Citrobacter spp Escherichia coli Enterobacter spp (excluding Enterobacter cloacae) Klebsiella spp Proteus spo Pseudomonas spp Serratia spp

The MicroScan® Synergies plus™ Gram-Negative Ceftazidime is not intended for use with:

Enterobacter cloacae

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°C in the WalkAway® S7 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

This document describes the 510(k) premarket notification for the MicroScan® Synergies plus™ Gram-Negative MIC/Combo Panels with Ceftazidime (1-16 µg/ml) (originally named MicroScan® rapID/S plus™ Gram-Negative MIC/Combo Panels in the initial 510(k) summary).

Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

The document states that the proposed device demonstrated substantially equivalent performance to an NCCLS frozen Reference Panel, as defined in the "Guidance on Review Criteria for Assessment of Antimicrobial Susceptibility Devices," dated March 8, 2000. Specifically, the criterion mentioned is "Essential Agreement of greater than 96%."

Acceptance Criteria	Reported Device Performance
Essential Agreement (EA) > 96% with reference method	Overall Essential Agreement > 96% for Ceftazidime
Acceptable Reproducibility and Precision	Demonstrated acceptable reproducibility and precision
Acceptable Quality Control results	Demonstrated acceptable results

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

Sample Size (Test Set): Not explicitly stated with a specific number for organisms or isolates. The document mentions "fresh and stock Efficacy isolates and stock Challenge strains." However, no precise count is provided.
Data Provenance: Not explicitly stated regarding country of origin. The study appears to be retrospective, using "stock Efficacy isolates and stock Challenge strains" alongside "fresh" isolates. It's an external evaluation.

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

Not applicable. The ground truth was established by an NCCLS (National Committee for Clinical Laboratory Standards, now Clinical and Laboratory Standards Institute - CLSI) frozen Reference Panel, not by human experts adjudicating individual cases.

4. Adjudication Method for the Test Set

Not applicable. The comparison was made against a standardized reference panel, not requiring adjudication of human-interpreted results.

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

Not applicable. This device is an automated antimicrobial susceptibility testing system, not an AI-assisted diagnostic tool for human interpretation.

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

Yes, a standalone performance evaluation was done. The device (MicroScan® Synergies plus™ Gram-Negative MIC/Combo Panel with Ceftazidime) was evaluated by comparing its results directly with an NCCLS frozen Reference Panel. The "WalkAway® SI System or equivalent" reads the panels and determines MICs, which is an automated process without direct human interpretation of the MIC determination itself. The study focused on the performance of the device itself against a reference standard.

7. The Type of Ground Truth Used

NCCLS frozen Reference Panel. This is a standardized, recognized method for determining antimicrobial susceptibility, serving as the gold standard for comparison in this type of device submission.

8. The Sample Size for the Training Set

Not applicable. This document describes a 510(k) for an updated version of an existing device (MicroScan® rapID/S plus™), not a de novo submission of a novel algorithmic device that would typically involve a distinct "training set" in the context of machine learning. The "training" in this context would likely refer to the initial development and validation of the broader MicroScan system and panel technology. The current submission focuses on the performance of a specific antimicrobial (Ceftazidime) on the panel.

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

Not applicable for the reasons mentioned above. The "ground truth" for the overall system development would have been established through extensive laboratory testing and validation against recognized reference methods (like NCCLS/CLSI standards) during the initial development of the MicroScan technology.

Summary

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Public Health Service

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: K020413 Trade/Device Name: MicroScan® Synergies plus™ Dried Gram-Negative MIC/Combo Panels with Ceftazidime (1-16 µg/ml) Regulation Number: 21 CFR 866.1645 Regulation Name: Fully Automated Short-Term Incubation Cycle Antimicrobial Susceptibility Devices Regulatory Class: Class II Product Code: LON Dated: July 30, 2004 Received: August 3, 2004

Dear Mr. Eusebio:

This letter corrects our substantially equivalent letter of July 17, 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,

Luddiitu. Pode for

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): K020413

MicroScan® Synergies plus™ Gram-Negative MIC/Combo Panels with Ceftazidime Device Name: (1 - 16 ug/ml)

Indications For Use:

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

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

Citrobacter spp Escherichia coli Enterobacter spp (excluding Enterobacter cloacae) Klebsiella spp Proteus spo Pseudomonas spp Serratia spp

The MicroScan® Synergies plus™ Gram-Negative Ceftazidime is not intended for use with:

Enterobacter cloacae

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)

Luella Poole

Division Sign-Off

Office of In Vitro Diagnostic Device Evaluation and Safety

Page 1 of __ 1

510(k) 020413

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K0204/13

JUL 1 7 2002

510(k) Summary

510(k) Submission Information:

Device Manufacturer:	Dade Behring Inc.
Contact name:	Maureen Mende, Group Manager Regulatory Affairs
Fax:	916-374-3144
Date prepared:	February 6, 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: Ceftazidime
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 Ceftazidime.

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 Expected Results determined prior to the evaluation. The rapID/S plus™ Gram-Negative Panel demonstrated acceptable performance with an overall Essential Agreement of greater than 96% for Ceftazidime when compared with the frozen Reference panel.

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

Quality Control testing demonstrated acceptable results for Ceftazidime.

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.”