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 Tetracycline on the Synergies plus** Gram-Negative MIC/Combo Panels.

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

Acinetobacter calcoaceticus
Acinetobacter spp
Escherichia coli
Enterobacter aerogenes
Klebsiella oxytoca
Klebsiella ozaenae
Klebsiella pneumoniae
Klebsiella rhinoscleromatis
Klebsiella spp
Shigella flexneri
Shigella sonnei
Shigella spp

Device Description

MicroScan® rapID/S plus™ Gram-Negative MIC/Combo Panels are designed for use in eteterming quantitative and/or qualitative antimicrobial agent susceptibility of colonies grown on solid media of rapidly growing and facultative anaerobic gram-negative bacilli. The MicroScan® rapID/S play® 40 growing aeroon: and faculiative androone grain negative occessed or equivalent (upgraded WalkAway® 40 or WalkAway® 96 instruments).

The antimicrobial susceptibility tests are miniaturizations of the broth dilution susceptibility test that have The antimicrobial susceptionity tests are inimations bridging the range of clinical interest and are been unders in micro-titer wells in dried form. rapID/S plus™ panels are inoculated with a standardized suspension of the organism and incubated at 35°C in the WalkAway® SI System or equivalent standardized suspension of the organism and measuration (MIC) for the test organism is determined by the lowest antimicrobial concentration showing inhibition of growth.

AI/ML Overview

The provided text describes the MicroScan® Synergies plus™ Gram-Negative MIC/Combo Panels with Tetracycline. This device is an antimicrobial susceptibility testing device.

Here's an analysis of the acceptance criteria and study information provided:

1. Table of Acceptance Criteria and Reported Device Performance

The text explicitly mentions: "The proposed MicroScan® rapID/S plus™ Gram-Negative MIC/Combo Panel demonstrated substantially The proposed MRTOSCall TaptDib Pras - One Negal Reference Panel, as defined in the FDA DRAFT document "Guidance on Review Criteria for Assessment of Antimicrobial Susceptibility Devices", DRAPT Uccument Ourlance on Reviow Criceation (510[k]) presents data in support of the MicroScan® rapID/S plus™ Gram-Negative MIC/Combo Panel Tetracycline. ... Essential Agreement of 92.7% for Tetracycline when compared with the frozen Reference panel."

Performance Metric	Acceptance Criteria (implied from FDA Guidance)	Reported Device Performance
Essential Agreement	Not explicitly stated in the document, but typically >90% for AST devices	92.7% for Tetracycline
Reproducibility	Acceptable reproducibility	Acceptable
Precision	Acceptable precision	Acceptable
Quality Control	Acceptable results	Acceptable

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

Sample Size: Not explicitly stated as a single number. The study utilized "fresh and stock Efficacy isolates and stock Challenge strains." However, the exact number of these isolates/strains used in the external evaluation is not provided.
Data Provenance: Not explicitly stated. The study refers to "external evaluation," but does not specify the country of origin. It also doesn't explicitly state whether the data was retrospective or prospective.

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

The document does not provide information on the number of experts used or their qualifications for establishing ground truth. The comparison was made against an "NCCLS frozen Reference panel" and "Expected Results," which implies a standardized reference method rather than expert consensus on individual cases.

4. Adjudication Method for the Test Set

The document does not describe an adjudication method involving human experts. The comparison was made against a "frozen Reference panel" and "Expected Results," indicating a comparison to a predefined standard.

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

No Multi-Reader Multi-Case (MRMC) Study was conducted. This device is an automated antimicrobial susceptibility testing device, not an imaging device that requires human interpretation. The "comparison with the evaluation" mentioned in the text refers to the device's results compared to a reference standard, not human readers improving with or without AI assistance.

6. Standalone Performance

Yes, standalone performance was evaluated. The study assessed the device's performance ("Essential Agreement of 92.7% for Tetracycline") by comparing its results directly against a "frozen Reference panel" and "Expected Results." This is a standalone evaluation of the algorithm/device itself without human intervention in the result interpretation.

7. Type of Ground Truth Used

The ground truth used was based on an "NCCLS frozen Reference panel" and "Expected Results." This represents a reference standard method rather than expert consensus, pathology, or outcomes data.

8. Sample Size for the Training Set

The document does not provide any information regarding a training set or its sample size. This is typical for AST devices, where the "training" (calibration/development) might involve optimizing the interpretation rules based on known antimicrobial-organism interactions and then validating against a reference standard.

9. How Ground Truth for the Training Set Was Established

Since no training set information is provided, there is no information on how ground truth for a training set was established.

Summary

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Image /page/0/Picture/2 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. In the center of the seal is a stylized caduceus, which is a symbol of medicine. The caduceus is made up of three intertwined snakes and a staff.

AUG 3 0 2004

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

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

Re: K020173 Trade/Device Name: MicroScan® Synergies plus™ Gram-Negative MIC/Combo Panels with Tetracycline (0.12-128 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 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,

Leedsville Road
Astin for

Sally A. Hojvat, M.Sc., Ph 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): K020173

MicroScan® Synergies plus™ Gram-Negative MIC/Combo Panels with Tetracycline Device Name: (0.12-128 ug/ml)

Indications For Use:

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

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

Acinetobacter calcoaceticus Acinetobacter spp Escherichia coli Enterobacter aerogenes Klebsiella oxytoca Klebsiella ozaenae Klebsiella pneumoniae Klebsiella rhinoscleromatis Klebsiella spp Shigella flexneri Shigella sonnei Shigella 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)

Freddie L. Pooly

vision Sign-Off

Office of In Vitro Diagnostic Device Evaluation and Safety

Page 1 of _ 1

510(k) 020 173

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K020173

FEB 0 6 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:	January 15, 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: Tetracycline
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 The proposed MRTOSCall TaptDib Pras - One Negal Reference Panel, as defined in the FDA DRAFT document "Guidance on Review Criteria for Assessment of Antimicrobial Susceptibility Devices", DRAPT Uccument Ourlance on Reviow Criceation (510[k]) presents data in support of the MicroScan® rapID/S plus™ Gram-Negative MIC/Combo Panel Tetracycline.

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-The extential evaluations were tessgired to commit an NCCLS frozen Reference panel. CCCallenge strains Negative Pater by Companie to performation with the evaluation. The rapID/S plus™ of the September Were compared to Expected Nesults dolernment prior of any essential Agreement of 92.7% for Tetracycline when compared with the frozen Reference panel.

Instrument reproducibility testing demonstrated acceptable reproducibility and precision with Tetracycline 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 Tetracycline.

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.”