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® S/ System or equivalent (upgraded WalkAway® 40 or WalkAway® 96) according to the Package Insert.

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

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

Escherichia coli (Piperacillin-resistant, ß-lactamase producing) Klebsiella oxytoca Klebsiella pneumoniae Morganella morganii Proteus mirabilis Proteus vulgaris Pseudomonas aeruginosa Serratia spp.

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

Acinetobacter spp. Citrobacter spp. Enterobacter spp

Device Description

MicroScan® rapID/S plus™ Gram-Negative MIC/Combo Panels are designed for use in determing MicroScan® rapLDS plus™ Gram-Negative This. Contines grown on solid media of rapidly of rapidly quantiative and facultative anaerobic gram-sacive bacilli. The MicroScan® rapIDS plas™ rapIDS plas™ Gramgrowing aerobic and facultative anaerobic graili-ligative basin. The University of System or equivalent (upgraded WalkAway® 40 or WalkAway® 96 instruments).

The antimicrobial susceptibility tests are miniaturizations susceptibility tost that have The antimicrobial susceptibility tests are inninatinations bridging in clinical interest and are been diluted in Mueller-Himon Broun to concentuations of the coulded and rehydrated with a presented in micro-titer wells in arred form. Tapines at 350 in the Walks ways System or equivalent standardized suspension of the organism and included at 35 ° In the was any was and one of the lowest antimicrobial concentration showing inhibition of growth.

AI/ML Overview

Acceptance Criteria and Study Details for MicroScan® Synergies Plus Gram-Negative MIC/Combo Panels with Piperacillin/Tazobactam

1. Table of Acceptance Criteria and Reported Device Performance

The provided 510(k) summary explicitly states that the device demonstrated "substantially equivalent performance" to the predicate device. The primary metric cited for this equivalence is a "greater than 94% Essential Agreement" with an NCCLS (National Committee for Clinical Laboratory Standards) frozen Reference panel. While specific numerical acceptance criteria for "Essential Agreement" are not explicitly listed in the summary, the statement implies that >94% essential agreement was the target for acceptance.

Acceptance Criteria (Implied)	Reported Device Performance (Piperacillin/Tazobactam)
Essential Agreement > 94%	Greater than 94% Essential Agreement
Acceptable Reproducibility	Acceptable reproducibility and precision
Acceptable Quality Control	Acceptable Quality Control results

Note: Essential Agreement is a common metric in antimicrobial susceptibility testing, representing the agreement between a new method and a reference method within a certain range of concentrations (e.g., +/- 1 dilution). The specific NCCLS document referenced (DRAFT document dated March 16, 2000, for Assessment of Antimicrobial Susceptibility Devices) would contain the precise definition and thresholds for Essential Agreement.

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

The 510(k) summary states, "The external evaluation was conducted with fresh and stock Efficacy isolates and stock Challenge strains." However, the exact sample size (number of isolates/strains) used for the test set is NOT explicitly provided in the given text.

Data Provenance: The study was an "external evaluation" conducted with "fresh and stock Efficacy isolates and stock Challenge strains." This implies the data was collected for the purpose of the study (prospective or a blend of prospective with pre-existing stock strains). The country of origin of the data is not specified, but given the context of FDA submission, it is likely that the testing was conducted in the United States or by organizations adhering to US regulatory standards.

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

The 510(k) summary states that the comparison was made against an "NCCLS frozen Reference panel." This implies that the ground truth was established by standardized laboratory methods as defined by NCCLS, rather than solely by human expert consensus or individual interpretation.

Therefore, the ground truth was established by a reference method that follows established guidelines, not by individual experts. The summary does not specify the number or qualifications of experts involved in the initial creation or validation of the NCCLS frozen Reference panel itself, as this panel serves as the established "gold standard" for comparison.

4. Adjudication Method for the Test Set

The concept of an adjudication method (like 2+1 or 3+1) is typically used when human readers or varying interpretations need to be reconciled. In this study, the device performance was compared against an "NCCLS frozen Reference panel," which serves as the established ground truth.

Therefore, no multi-reader adjudication method was employed as the primary comparison point was a standardized laboratory reference method, not individual human interpretations requiring consensus.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No MRMC comparative effectiveness study was done. The summary describes a standalone performance evaluation of the device against a reference standard for determining antimicrobial susceptibility. There is no mention of human readers, AI assistance, or comparing human performance with and without AI.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

Yes, a standalone study was performed. The study described evaluates the performance of the "MicroScan® rapID/S plus™ Gram-Negative MIC/Combo Panels" (the device under review) when read on the "WalkAway® S/ System or equivalent" against an "NCCLS frozen Reference panel." This constitutes an evaluation of the device as a system for determining MICs, without human intervention in interpreting the results once the automated system has processed the panel.

7. Type of Ground Truth Used

The type of ground truth used was a "NCCLS frozen Reference panel." This indicates a highly standardized, laboratory-based reference method for determining minimum inhibitory concentrations (MICs) of antimicrobial agents. The NCCLS (now CLSI - Clinical and Laboratory Standards Institute) publishes consensus standards for antimicrobial susceptibility testing, and a "frozen reference panel" would represent a meticulously characterized set of strains with known MICs determined by these standardized methods.

8. Sample Size for the Training Set

The 510(k) summary does NOT provide information regarding the sample size for a training set. Since this is a submission for a microdilution MIC panel (a diagnostic test kit/system) rather than an AI/machine learning algorithm that requires explicit training data, the concept of a "training set" in the context of machine learning is not directly applicable here. The device's performance is based on its chemical and biological reactions, and the "training" for such a system would involve its design, manufacturing controls, and potentially internal validation during development, not a separate data-driven training phase in the AI sense.

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

As the device is not an AI/machine learning algorithm that undergoes a training phase with a distinct "training set" of data, this question is not applicable in the context of the provided 510(k) summary. The "ground truth" referenced in the summary pertains to the external validation (test set) using the NCCLS reference standard.

Summary

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510(k) Summary

K 020511

510(k) Submission Information:
Device Manufacturer:	Dade Behring Inc.
Contact name:	Maureen Mende, Group Manager Regulatory Affairs
Fax:	916-374-3144
Date prepared:	February 13, 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: Piperacillin/Tazobactam
Predicate device:	MicroScan Dried Gram Negative MIC/Combo Panels

510(k) Summary:

The proposed MicroScan® rapID/S plus™ Gram-Negative MIC/Combo Panel demonstratled substantially The proposed MicroScan® Tapp273 plus - Gran-Negarro Parel, as defined in the FDA
equivalent performance with an NCCLS frozen Referice ration Successibility Davices" equivalent performance when compared with an Assessment of Animisrobial Susceptibility Devices", DRAFT document Culture on Review Citieria 10 110[k]) presents data in support of the MicroScan® dated March '6, 2000. - The Premient with Piperacillin/Tazobactam.

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 rapIDS plis" Grain The external evaluations were designed to commit the acceptabling on area. Challenge stains Negative Panel by companies with an to evelopment. The rapIDS plus™ CrapIDS plus™ Cram-Negative were compared to Frozel Results determined prof to the overall Essential Agreement of greater than 94 % for I and demonstrator associated with the frozen Reference panel.

testing demonstrated acceptable reproducibility and precision with Instrument reproducibility Instrument reproductioning testing includio preparation method and the WalkAway® SI System or r perachin ruzobucture walkAway® 40 or WalkAway® 96 instruments).

Quality Control testing demonstrated acceptable results for Piperacillin/Tazobactam.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/1/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is a stylized image of a human figure with outstretched arms. The figure is made up of three curved lines that resemble a bird in flight.

Public Health Service

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

SEP 1 4 2004

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

Re: K020511

Trade/Device Name: MicroScan® Synergies Plus Gram Negative MIC/Combo Panels with Piperacillin/Tazobactam (1/4, 4/4 - 256/4 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: February 13, 2002 Received: February 15, 2002

Dear Mr. Eusebio:

This letter corrects our substantially equivalent letter of March 6, 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,

Freddie Poole

Salty 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): K020511

Device Name: MicroScan® Synergies plus™ Gram-Negative MIC/Combo Panels with Piperacillin/Tazobactam (1/4, 4/4 - 256/4 ug/ml)

Indications For Use:

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

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

Escherichia coli (Piperacillin-resistant, ß-lactamase producing) Klebsiella oxytoca Klebsiella pneumoniae Morganella morganii Proteus mirabilis Proteus vulgaris Pseudomonas aeruginosa Serratia spp.

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

Acinetobacter spp. Citrobacter spp. Enterobacter spp

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)

freddin M. Poole

Sision Sign-Off

Page 1 of ____________________________________________________________________________________________________________________________________________________________________

Office of In Vitro Diagnostic Device Evaluation and Safely

510(k) K020511

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.”