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 Ichnemore: "This "how and WalkAway" 96) according to the Package Insert.

This particular submission is for the antimicrobial Meropenem on the rapID/S plus " Gram-Negative MIC/Combo Panels.

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

Acinetobacter spp Aeromonas hydrophila Citrobacter koseri (diversus) Citrobacter freundii Escherichia coli Enterobacter cloacae Hafnia alvei Klebsiella oxytoca Klebsiella pneumoniae Morganella morganii Pasteurella multocida Proteus mirabilis Proteus vulgaris Serratia marcescens Shigella spp Salmonella spp Yersinia enterolitica

The MicroScan® rapID/S plus "Gram-Negative with Meropenem is not intended for use with:

Pseudomonas aeruginosa

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® SY 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® SV 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

Here's an analysis of the provided text, focusing on the acceptance criteria and the study details:

Device Name: MicroScan® plus™ Gram-Negative MIC/Combo Panels with Meropenem (0.12-32 µg/ml)

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Metric	Acceptance Criteria (target performance)	Reported Device Performance (Meropenem)
Comparative Study	Overall Essential Agreement (vs. NCCLS frozen panel)	> (not explicitly stated, but implied by "acceptable")	> 97.3%
Reproducibility Testing	Reproducibility and Precision	Acceptable	Acceptable
Quality Control Testing	Quality Control Results	Acceptable	Acceptable

Additional context: The "Guidance on Review Criteria for Assessment of Antimicrobial Susceptibility Devices," dated March 8, 2000, is mentioned, suggesting that the criteria followed this FDA DRAFT document. While a specific numerical threshold for "Essential Agreement" isn't provided as a literal "acceptance criteria" in the text, the statement of "greater than 97.3%" being acceptable implies it met the internal or FDA's expected threshold.

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

Test Set Description: "fresh and stock Efficacy isolates and stock Challenge strains."
Sample Size: Not explicitly stated. The text only mentions "external evaluation was conducted."
Data Provenance: Not explicitly stated. There's no information about the country of origin or whether the data was retrospective or prospective.

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

Not applicable. The ground truth for the comparative study was established using an NCCLS frozen Reference Panel and Expected Results determined prior to the evaluation for Challenge strains, not by individual experts or a consensus panel in the traditional sense of human readers interpreting images or data.

4. Adjudication Method for the Test Set

Not applicable. The ground truth was based on an NCCLS frozen Reference Panel and pre-determined Expected Results, not a process requiring adjudication of expert opinions.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No. This is an antimicrobial susceptibility device, not a medical imaging device. The study design described is a comparative study against a reference method (NCCLS frozen panel), not an MRMC study involving human readers with and without AI assistance.

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

Yes. The study focused on the performance of the MicroScan® rapID/S plus™ Gram-Negative MIC/Combo Panel when read on the WalkAway® SY System (or equivalent), comparing its results directly to the NCCLS frozen Reference Panel. This represents the standalone performance of the device and its automated reading system.

7. The Type of Ground Truth Used

For the "Efficacy isolates": NCCLS frozen Reference Panel. The NCCLS (now CLSI - Clinical and Laboratory Standards Institute) provides standardized methods and reference materials for antimicrobial susceptibility testing, so their frozen panels serve as a recognized ground truth for comparison.
For "Challenge strains": "Expected Results determined prior to the evaluation." These expected results would likely be established through rigorous laboratory testing using a gold standard method.

8. The Sample Size for the Training Set

Not applicable. The text describes a comparative performance study of an in vitro diagnostic device, not a machine learning model that requires a "training set" in the conventional sense. The device's underlying principles are based on established microbiology techniques, not trained on a distinct dataset like an AI algorithm.

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

Not applicable, as there is no mention of a training set for a machine learning model.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. 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 caduceus, a symbol often associated with medicine and healthcare.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

AUG 3 0 200

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

K020249 Re: Trade/Device Name: MicroScan® plus™ Gram-Negative MIC/Combo Panels with Meropenem (0.12-32 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 February 6, 2002, regarding the trade I his letter corrects our subominatify oque 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 we nave roviewed your becamed in in it is substantially equivalent [(for the indications for use stated in the enclosure)] to legally marketed predicate devices marketed in interstate for ass based in the enactment date of the enactment date of the Medical Device Amendments or to commerce print to May 20, 1978, are exactions of the Federal Food. Drug, Drug, do floos that have over 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 therefore, markeville as a reactivements 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 11 your de roo to additional controls. Existing major regulations affecting your device can be may be subject to additions, 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 I lease of actives and I Drivination that your device complies with other requirements of the Act that I Dri has intact a wond regulations administered by other Federal agencies. You must of any I coclar statutes and regulations annuding, but not limited to: registration and listing (21 Comply with an the Fee orequirements)01); good manufacturing practice requirements as set OF K Fart 607); adoling (21 CFR Part 820); and if applicable, the electronic form in the quality by evense (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) This letter will anow you to commission of substantial equivalence of your device to a legally premailed notification. The Pro Massification 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 11 Jud as a sport 809.10 for in vitro diagnostic devices), please contact the Office of Compliance additionally Part 00710 For questions on the promotion and advertising of your device, at ( 3 ) 2 t t 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. Rood for

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): K020249

MicroScan® Synergies plus™ Gram-Negative MIC/Combo Panels with Meropenem Device Name: (0.12 - 32 ug/ml)

Indications For Use:

This particular submission is for the antimicrobial Meropenem on the rapID/S plus " Gram-Negative MIC/Combo Panels.

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

The MicroScan® rapID/S plus "Gram-Negative with Meropenem is not intended for use with:

Pseudomonas aeruginosa

X 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)

ncurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Luddi Pool
Division Sign-Off

Division Sign 511

Office of In Vitro Diagnostic Device Evaluation and Safety

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510(k) 020249

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FEB 0 6 2002

K020249

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:	January 22, 2002
Product Name:	Microdilution Minimum Inhibitory Concentration (MIC) Panel
Trade Name:	MicroScan® rapID/S plus ™ Gram-Negative MIC/Combo panel
Intended Use:	To determine antimicrobial agent susceptibility
510(k) Notification:	Antimicrobials: Meropenem
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 Meropenem.

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 97.3% for Meropenem when compared with the frozen Reference panel.

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

Quality Control testing demonstrated acceptable results for Meropenem.

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.”