MICROSCAN MICROSTREP PLUS PANEL ERYTHROMYCIN (0.015 TO 2 MCG/ML) by DADE BEHRING, INC.

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 Erythromycin, at concentrations of 0.015 to 2 mcg/ml on the MicroScan MICroSTREP plus® Panel.

The organisms which may be used for Erythromycin susceptibility testing on this panel are:

Streptococcus pneumoniae Streptococcus pyogenes viridans group streptococci

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 15 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

This 510(k) summary describes the MicroScan MICroSTREP plus® Panel for determining bacterial susceptibility to Erythromycin using a MicroScan® WalkAway instrument an in vitro diagnostic device.

Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance (Erythromycin)
Overall Essential Agreement (compared to Expected Result)	98.6%
Instrument Reproducibility	Acceptable
Quality Control Testing	Acceptable

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

Sample Size: Not explicitly stated as a number. The document mentions "stock and CDC Challenge strains" for external evaluation. It indicates the study was designed to confirm acceptability by comparing performance with "Expected Results determined before the evaluation," implying a retrospective comparison against a pre-established reference standard.
Data Provenance: The document refers to "external evaluation" but does not specify the country of origin of the data. The use of "CDC Challenge strains" suggests a U.S. context for some of the strains, but this doesn't definitively determine the origin of all test data.

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

This information is not provided in the given text. The ground truth (referred to as "Expected Result" or "CLSI frozen Reference Panel") was established prior to the evaluation, but the specifics of who established it or their qualifications are not detailed.

4. Adjudication Method for the Test Set

This information is not provided. The document states that the test set's performance was compared with an "Expected Result generated on a CLSI frozen Reference Panel." This implies a reference standard rather than multi-expert adjudication for individual test cases.

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

No, an MRMC comparative effectiveness study was not done. This device is an automated instrument for reading antimicrobial susceptibility panels, not an AI intended to assist human readers in interpretation. Therefore, the concept of "how much human readers improve with AI vs without AI assistance" is not applicable here.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done

Yes, a standalone performance evaluation was conducted. The study assesses the performance of the MicroScan® WalkAway instrument in reading the MICroSTREP plus® Panel with Erythromycin. The performance is compared against an "Expected Result," implying the instrument's automated reading capability without human intervention for interpretation.

7. The Type of Ground Truth Used

The ground truth used was based on an Expected Result generated on a CLSI frozen Reference Panel and determined before the evaluation. This serves as a reference standard for antimicrobial susceptibility testing.

8. The Sample Size for the Training Set

This information is not provided. The document describes an evaluation of an existing measurement instrument with an added capability, not the development or training of a new algorithm. It does not mention a training set in the context of an AI/ML model where a training set would be explicitly defined.

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

This information is not applicable/provided as no training set for an AI/ML model is described or referenced in the document.

Summary

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KO62375

OCT 26 2006

510(k) Summary Information:

Device Manufacturer:	Dade Behring Inc.
Contact name:	Maureen Mende, Regulatory Affairs Group Manager
Phone/Fax:	916-374-3174/916-374-3144
Date prepared:	August 2, 2006
Product Name:	Microdilution Minimum Inhibitory Concentration (MIC) Panels
Trade Name:	MicroScan MICroSTREP plus® Panel
Intended Use:	To determine bacterial susceptibility to Erythromycin
Indication for Use:	For determining antimicrobic susceptibility with aerobicstreptococci including Streptococcus pneumoniae
Predicate device:	MicroScan® MICroSTREP plus® Panel

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 Erythromycin 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 the MICroSTREP plus® Panel by comparing its performance with Expected Results determined before the evaluation. The MICroSTREP plus® Panel demonstrated acceptable performance with

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an overall Essential Agreement of 98.6% for Erythromycin instrument read results compared with the Expected Result.

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

Quality Control testing demonstrated acceptable results for Erythromycin.

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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

OCT 26 2006

Re: K062375

Trade/Device Name: MicroScan MICroSTREP plus® Panel Erythromycin (0.015 to 2 mcg/ml) Regulation Number: 21 CFR § 866.1640 Regulation Name: Antimicrobial susceptibility test powder Regulatory Class: II Product Code: LRG, LTT Dated: August 2, 2006 Received: September 25, 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, 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, anton

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

062375
(To be assigned by FDA)

(To be assigned by FDA

MicroScan MICroSTREP plus® Panel Erythromycin (0.015 to 2 mcg/ml)

Intended Use

Device Name:

510(k) No .:

Indications for Use:

To determine bacterial antimicrobial agent susceptibility

This particular submission is for the addition of instrument read capability of the antimicrobial Erythromycin, at concentrations of 0.015 to 2 mcg/ml on the MicroScan MICroSTREP plus® Panel.

The organisms which may be used for Erythromycin susceptibility testing on this panel are:

Streptococcus pneumoniae Streptococcus pyogenes viridans group streptococci

Prescription Use X (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

AND/OR

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

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Division Sign-Off

Office of In Vites Diagnostic Device Evaluation and Safety

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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).