The MicroScan MICroSTREP plus® Panel is used to determine quantitative and/or qualitative antimicrobial agent susceptibility of colonies grown on solid media of aerobic streptococci, including Streptococcus pneumoniae. After inoculation, panels are incubated for 20 - 24 hours at 35°C +/- 1°C in a non-CO2 incubator, and read visually according to the Package Insert. Additionally, the panels may be incubated in and read by a MicroScan® WalkAway instrument. This particular submission is for the addition of instrument read capability of the antimicrobial Cefepime, at concentrations of 0.015 - 8 mcg/ml on the MicroScan MICroSTREP plus® Panel. The organisms which may be used for Cefepime susceptibility testing on this panel are: Streptococcus pneumoniae, Streptococcus pyogenes (Lancefield's Group A streptococci), Streptococcus agalactiae (Lancefield's Group B streptococci), Viridans group streptococci

Device Description

The antimicrobial susceptibility tests are miniaturizations of the broth dilution susceptibility test. I ho annimer only case of at a started in water, buffer or minute concentrations of broth to concentrations bridging the range of clinical interest. Panels are rehydrated with 115 ul Muellereontoont one origing the with 2-5% lysed horse blood (LHB) and buffered with 50 mM HEPES, rfinen orolation of the broth with a standardized suspension of the organism in saline. After incubation in a non-CO2 incubator for 20-24 hours, the minimum inhibitory concentration (MIC) for the test organism is manually read by observing the lowest antimicrobial concentration showing inhibition of growth. Additionally, the panels may be incubated in and read by a MicroScan WalkAway instrument.

AI/ML Overview

The information provided is centered around the 510(k) submission for the MicroScan MICroSTREP plus® Panel for determining bacterial susceptibility to Cefepime, specifically for the instrument read method. This submission does not pertain to an AI device or a comparative effectiveness study involving human readers with and without AI assistance. Therefore, some of the requested categories, such as "multi reader multi case (MRMC) comparative effectiveness study," "effect size of how much human readers improve with AI vs without AI assistance," and "standalone (i.e. algorithm only) performance," are not directly applicable or cannot be extracted from the given text.

Based on the provided text, here is a summary of the acceptance criteria and the study details:

Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Acceptance Criteria	Reported Device Performance
Overall Essential Agreement	Defined in FDA document "Class II Special Controls Guidance Document: Antimicrobial Susceptibility Test (AST) Systems; Guidance for Industry and FDA", dated February 5, 2003. (Specific percentage not explicitly stated in document, but generally high for AST systems to assure clinical relevance.)	95.7% for Cefepime instrument read results compared with Expected Result.
Instrument Reproducibility	Acceptable reproducibility and precision for Cefepime and the WalkAway® instrument.	Demonstrated acceptable reproducibility and precision.
Quality Control	Acceptable results for Cefepime.	Demonstrated acceptable results.

Study Details

Study Parameter	Description
1. Sample size used for the test set	Not explicitly stated as a numerical value. The evaluation was conducted with "stock and CDC Challenge strains."
2. Data provenance (e.g. country of origin of the data, retrospective or prospective)	Not explicitly stated regarding country of origin. The study was an "evaluation" designed to confirm acceptability, suggesting it was prospective for the purpose of the 510(k) submission. "Stock and CDC Challenge strains" imply controlled, laboratory-based isolates.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts	Not applicable. Ground truth was established by "Expected Results determined before the evaluation" based on a "CLSI frozen Reference Panel." This suggests a standardized methodology rather than individual expert consensus from a specified number of experts.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set	Not applicable. Ground truth was based on a "CLSI frozen Reference Panel" (Expected Results), and comparison was made against this reference, not adjudicated by human experts in the context of interpretation discrepancies.
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 submission is for an instrument-read method of an antimicrobial susceptibility panel, not an AI or human-in-the-loop diagnostic system. The focus is on the performance of the instrument reading compared to a reference standard.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done	This is a standalone performance assessment of the instrument-read method. The "algorithm" here refers to the instrument's capability to read the MICroSTREP plus® Panel with Cefepime, without human intervention for the reading process itself. Manual reading is mentioned as an alternative method in the product description.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)	"Expected Results determined before the evaluation" based on a "CLSI frozen Reference Panel." This represents a standardized, laboratory-based reference method, which is the established "ground truth" for antimicrobial susceptibility testing.
8. The sample size for the training set	Not applicable. This document describes a validation study for an existing instrument's capability, not the development of a novel machine learning algorithm that requires a "training set." The instrument's underlying reading mechanism would have been developed and "trained" separately.
9. How the ground truth for the training set was established	Not applicable, as no training set for a new algorithm is discussed.

Summary

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510(k) Summary Information:

Device Manufacturer: Dade Behring Inc.
Contact name:	May Morishima, Regulatory Affairs Administrator	NOV - 1 2006
Phone/Fax:	916-374-2006/916-374-3144
Date prepared:	October 4, 2006
Product Name:	Microdilution Minimum Inhibitory Concentration (MIC) Panels
Trade Name:	MicroScan MICroSTREP plus® Panel
Intended Use:	To determine bacterial susceptibility to Cefepime
Indication for Use:	For determining antimicrobic susceptibility with aerobic streptococciincluding Streptococcus pneumoniae
Predicate device:	MicroScan® MICroSTREP plus® Panel (K021188)

510(k) Summary:

The proposed instrument read method for the MicroScan MICroSTREP plus® Panel demonstrated I ho propoted mixalent performance with streptococcal isolates when compared with an expected result generated on a CLSI frozen Reference Panel, as defined in the FDA document "Class II Special Controls Guidance Document: Antimicrobial Susceptibility Test (AST) Systems; Guidance for Industry and FDA", dated February 5, 2003.

This Premarket Notification (510[k]) presents data in support of reading the MICroSTREP plus® Panel with Cefepime on the MicroScan® WalkAway instrument.

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The evaluations were conducted with stock and CDC Challenge strains. The evaluations were designed to confirm the acceptability of the proposed instrument read method for the MICroSTREP plus® Panel by comparing its performance with Expected Results determined before the evaluation. The MICroSTREP plus® Panel demonstrated acceptable performance with an overall Essential Agreement of 95.7% for Cefepime instrument read results compared with the Expected Result.

Instrument reproducibility testing demonstrated acceptable reproducibility and precision with Cefepime and the WalkAway® instrument.

Quality Control testing demonstrated acceptable results for Cefepime.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus, a symbol often associated with medicine and healthcare. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" is arranged in a circular pattern around the caduceus. The logo is in black and white.

Public Health Service

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Ms. May Morishima Regulatory Affairs Administrator Dade Behring, Inc. 1584 Enterprise Boulevard West Sacramento, CA 95691-9972

NOV - 1 2006

Re: K063099

Trade/Device Name: MicroScan MICroSTREP plus® Panel Cefepime (0.015 - 8 mcg/ml) Regulation Number: 21 CFR § 866.1640 Regulation Name: Antimicrobial susceptibility test powder Regulatory Class: II Product Code: LRG, LTT Dated: October 4, 2006 Received: October 11, 2006

Dear Ms. Morishima:

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 application (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 such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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 Parts 801 and 809); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).

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This letter will allow you to begin 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 information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (240)276-0450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.

Sincerely yours,

Sally, autum

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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Indication for Use Statement

510(k) No.:	K063099(To be assigned by FDA)
Device Name:	MicroScan MICroSTREP plus® PanelCefepime (0.015 - 8 mcg/ml)
Intended Use	To determine bacterial antimicrobial agent susceptibility
Indications for Use:	The MicroScan MICroSTREP plus® Panel is used to determinequantitative and/or qualitative antimicrobial agent susceptibility ofcolonies grown on solid media of aerobic streptococci, includingStreptococcus pneumoniae. After inoculation, panels are incubatedfor 20 - 24 hours at 35°C +/- 1°C in a non-CO2 incubator, and readvisually according to the Package Insert. Additionally, the panels maybe incubated in and read by a MicroScan® WalkAway instrument.This particular submission is for the addition of instrument readcapability of the antimicrobial Cefepime, at concentrations of0.015 - 8 mcg/ml on the MicroScan MICroSTREP plus® Panel.The organisms which may be used for Cefepime susceptibility testingon this panel are:Streptococcus pneumoniaeStreptococcus pyogenes (Lancefield's Group A streptococci)Streptococcus agalactiae (Lancefield's Group B streptococci)Viridans group streptococci
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 Tu. Poole
Division Sign-Off

Page 1 of _1

Office of In Vitro Diagnostic Device Evaluation and Safety

K063099

Regulation Number and Section

§ 866.1640 Antimicrobial susceptibility test powder.

(a)
Identification. An antimicrobial susceptibility test powder is a device that consists of an antimicrobial drug powder packaged in vials in specified amounts and intended for use in clinical laboratories for determining in vitro susceptibility of bacterial pathogens to these therapeutic agents. Test results are used to determine the antimicrobial agent of choice in the treatment of bacterial diseases.(b)
Classification. Class II (performance standards).