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 Cefaclor, at concentrations of 0.5 to 8 mcg/ml on the MicroScan MICroSTREP plus® Panel. The organisms which may be used for Cefaclor susceptibility testing in this panel are: Streptococcus pneumoniae

Device Description

The antimicrobial susceptibility tests are miniaturizations of the broth dilution susceptibility test. Various antimicrobial agents are diluted in water, buffer or minute concentrations of broth to concentrations bridging the range of clinical interest. Panels are rehydrated with 115 µl Mueller-Hinton broth supplemented with 2-5% lysed horse blood (LHB) and buffered with 50 mM HEPES, after inoculation 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

Acceptance Criteria and Study Details for MicroScan MICroSTREP plus® Panel (Cefaclor)

This submission describes the acceptance criteria and study proving the MicroScan MICroSTREP plus® Panel meets these criteria for determining bacterial susceptibility to Cefaclor using the MicroScan WalkAway instrument.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Acceptance Criteria	Reported Device Performance
Overall Performance	"Acceptable performance with an overall Essential Agreement" as defined by the FDA document "Class II Special Controls Guidance Document: Antimicrobial Susceptibility Test (AST) Systems; Guidance for Industry and FDA", dated February 5, 2003, for instrument read results compared with Expected Results.	Overall Essential Agreement: 92.5% for Cefaclor instrument read results compared with the Expected Result.
Reproducibility	Acceptable reproducibility and precision for Cefaclor instruments and the WalkAway® instrument.	Demonstrated acceptable reproducibility and precision with Cefaclor and the WalkAway® instrument. (Specific quantitative metrics for reproducibility are not provided in this summary but are stated to be acceptable.)
Quality Control	Acceptable results for Cefaclor during Quality Control testing.	Demonstrated acceptable results for Cefaclor during Quality Control testing. (Specific quantitative metrics for quality control are not provided in this summary but are stated to be acceptable.)

Note: Essential Agreement (EA) for AST devices typically refers to the percentage of MIC results that are within one doubling dilution of the reference method's MIC result. The FDA guidance document (cited in the submission) specifies the expected thresholds for EA for different AST systems. While the exact threshold isn't explicitly stated in this summary, the 92.5% achieved is reported as "acceptable."

2. Sample Size and Data Provenance for the Test Set

Sample Size for Test Set: The study was conducted with "stock and CDC Challenge strains." The exact number of strains/isolates is not explicitly stated in the provided text.
Data Provenance: The external evaluation was conducted as described, implying prospective testing of these strains. The country of origin for the data is not specifically mentioned, but given the manufacturer (Dade Behring Inc.) and FDA submission, it can be inferred to be a US-based or internationally collected set of strains used in a US regulatory context.

3. Number of Experts and Qualifications for Ground Truth

Number of Experts: Not specified.
Qualifications of Experts: Not specified. The ground truth was established as "Expected Results determined before the evaluation," and also referenced a "CLSI frozen Reference Panel." This suggests that the ground truth was derived from established reference methods, likely interpreted by qualified microbiologists, but the specifics are not detailed.

4. Adjudication Method for the Test Set

The text describes the comparison of instrument read results with an "Expected Result generated on a CLSI frozen Reference Panel." This indicates that the CLSI reference panel serves as the gold standard against which the device's performance is measured.
There is no mention of a traditional expert adjudication (e.g., 2+1, 3+1 consensus) of the device's results. Instead, the device's results are directly compared to the established "Expected Result" from the CLSI reference method.

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

No, an MRMC comparative effectiveness study was not explicitly done. This study focuses on the mechanical/automated reading of the MicroScan MICroSTREP plus® Panel by the MicroScan WalkAway instrument compared to a defined reference standard ("Expected Result"). The focus is on the instrument's performance, not on direct human reader improvement with or without AI assistance. The original method, to which this instrument-read method is an addition, involves manual reading, but the study described here is not a comparison of human readers with and without the instrument.

6. Standalone Performance Study

Yes, a standalone study was done. The study's primary objective was to evaluate the "proposed instrument read method" (i.e., the algorithm/instrument's performance without human intervention to interpret the results once the instrument has read them) against a "CLSI frozen Reference Panel" and its "Expected Result." The 92.5% Essential Agreement reflects this standalone performance of the MicroScan WalkAway instrument in reading the panels.

7. Type of Ground Truth Used

The ground truth used was based on results generated on a CLSI (Clinical and Laboratory Standards Institute) frozen Reference Panel, which is a widely accepted standard for antimicrobial susceptibility testing. These are referred to as "Expected Results determined before the evaluation." This is a highly robust and standardized form of ground truth for this type of in vitro diagnostic device.

8. Sample Size for the Training Set

Not explicitly stated. The provided summary describes the validation of the instrument-read method, not the development or training of the underlying algorithm for the instrument reading. While the instrument likely incorporates algorithms, no information on a specific "training set" or its size is given in this document.

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

Not applicable / Not explicitly stated. As noted above, the document focuses on the performance validation rather than the internal development of the instrument's reading capabilities. Therefore, how any "training set" ground truth might have been established for the instrument's internal algorithms is not detailed. The study's focus is on comparing the instrument's output to an independent ground truth reference method.

Summary

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NOV - 9 2006

510(k) Summary Information:

Device Manufacturer:	Dade Behring Inc.
Contact name:	Shannon Popson, Regulatory Affairs Manager
Phone/Fax:	916-374-3330/916-374-3144
Date prepared:	October 5, 2006
Product Name:	Microdilution Minimum Inhibitory Concentration (MIC) Panels
Trade Name:	MicroScan MICroSTREP plus® Panel
Intended Use:	To determine bacterial susceptibility to Cefaclor
Indication for Use:	For determining antimicrobic susceptibility with aerobic streptococci,including Streptococcus pneumoniae
Predicate device:	MicroScan MICroSTREP plus® Panel (K020691)

510(k) Summary:

The proposed instrument read method for the MicroScan MICroSTREP plus Panel demonstrated substantially equivalent 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 Cefaclor on the MicroScan® WalkAway instrument.

The external evaluation was conducted with stock and CDC Challenge strains. The external evaluations were designed to confirm the acceptability of the proposed instrument read method for

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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 92.5% for Cefaclor instrument read results compared with the Expected Result.

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

Quality Control testing demonstrated acceptable results for Cefaclor.

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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 consists of a stylized eagle with three bars forming its body and wings. The eagle is facing right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.

Public Health Service

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Ms. Maureen Mende Regulatory Affairs Group Manager Dade Behring, Inc. 1584 Enterprise Boulevard West Sacramento, CA 95691-9972 NOV - 9 2006

Re: K063102 Trade/Device Name: MicroScan MICroSTREP plusio Panel Cefaclor (0.5 - 8 mcg/ml) Regulation Number: 21 CFR § 866.1640 Regulation Name: Antimicrobial susceptibility test powder Regulatory Class: II Product Code: LRG, LTT Dated: October 5, 2006 Received: October 10, 2006

Dear Ms. Mende:

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, perrects 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 of 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 tollorities (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.htmil.

Sincerely yours.

Sally, artin

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.:	K063102(To be assigned by FDA)
Device Name:	MicroScan MICroSTREP plus® PanelCefaclor (0.5 - 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 incubated for20 - 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 Cefaclor, at concentrations of 0.5 to 8mcg/ml on the MicroScan MICroSTREP plus® Panel.The organisms which may be used for Cefaclor susceptibility testing inthis panel are:Streptococcus pneumoniae
Prescription UseX(Part 21 CFR 801 Subpart D)	AND/OROver-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)

Fuddie Poole
Division Sign-Off

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Office of In Vitro Diagnostic Device Evaluation and Safety

K063/02

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).