To determine bacterial antimicrobial agent susceptibility. 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. This particular submission is for the addition of the antimicrobial Gatifloxacin at concentrations of 0.06 to 8 mcg/ml to the test panel. The organisms which may be used for Gatifloxacin susceptibility testing in this panel are; Streptococcus pneumoniae, Streptococcus pyogenes.

Device Description

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. 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 ul 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.

AI/ML Overview

The MicroScan® MICroSTREP plus™ Panel is a device used to determine bacterial susceptibility to antimicrobial agents, specifically Gatifloxacin, for aerobic streptococci, including Streptococcus pneumoniae and Streptococcus pyogenes.

Here's an analysis of the acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria (from FDA Draft Guidance, March 8, 2000)	Reported Device Performance
Essential Agreement (EA) with NCCLS frozen Reference Panel	Overall 100% for Gatifloxacin
Reproducibility of Gatifloxacin testing	Acceptable
Quality Control (QC) testing for Gatifloxacin	Acceptable results

Note: The specific numerical thresholds for "acceptable" reproducibility and QC results are not provided in the summary. The Essential Agreement (EA) typically refers to the percentage of MICs that are within ±1 doubling dilution of the reference method.

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

Sample Size: The document mentions "fresh and stock Efficacy isolates and stock Challenge strains" for the external evaluation. However, the exact number of isolates or strains used in the test set is not specified in this summary.
Data Provenance: The study involved "external evaluation." The country of origin of the data is not specified. The mention of "fresh and stock Efficacy isolates" suggests a mix, and "stock Challenge strains" indicates a controlled set of organisms. It is not explicitly stated whether the study was retrospective or prospective, but given the nature of susceptibility testing and the use of "fresh" isolates, it likely involved a prospective element or a combination of both.

3. Number of Experts Used to Establish Ground Truth and Qualifications:

Number of Experts: The document does not specify the number of experts involved in establishing the ground truth.
Qualifications of Experts: The document does not specify the qualifications of any experts involved. The ground truth was established by comparing the device's performance to an "NCCLS frozen Reference Panel," which implicitly suggests the reference panel itself adheres to expert-defined standards.

4. Adjudication Method for the Test Set:

The document does not specify an adjudication method (such as 2+1 or 3+1). The performance was directly compared to the NCCLS frozen Reference Panel, which served as the gold standard.

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

No, an MRMC comparative effectiveness study was not done in the context of human readers improved by AI assistance. This device is an in-vitro diagnostic (IVD) for antimicrobial susceptibility testing, and the performance assessment focuses on the accuracy of the device itself against a reference method, not on human interpretation or AI assistance.

6. Standalone (Algorithm Only) Performance:

Yes, a standalone performance study was done. The entire evaluation described is a standalone performance study, as it assesses the performance of the MicroScan® MICroSTREP plus™ Panel directly. The device itself determines the MIC, and the "manual read by observing the lowest antimicrobial concentration showing inhibition of growth" is the output of the "algorithm" equivalent (the visual observation based on the growth pattern). There is no mention of "human-in-the-loop" interaction beyond the standard visual interpretation of the panel incubation results, which is inherent to this type of device.

7. Type of Ground Truth Used:

The ground truth used was a "NCCLS frozen Reference Panel." This reference panel serves as the accepted gold standard for determining antimicrobial minimum inhibitory concentrations (MICs). The NCCLS (National Committee for Clinical Laboratory Standards, now Clinical and Laboratory Standards Institute - CLSI) establishes standards for susceptibility testing, so a reference panel endorsed by NCCLS represents a highly authoritative and standardized ground truth.

8. Sample Size for the Training Set:

The document does not provide information regarding a separate "training set" or its size. For IVD devices like this, the development process typically involves internal validation and optimization, but the provided summary focuses on the external performance evaluation against a reference standard. If machine learning or AI models were involved, a training set would be explicitly mentioned; however, this device appears to be based on a traditional broth dilution method with visual interpretation.

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

As a separate "training set" is not mentioned and the technology described is not explicitly an AI/ML device, this question is not applicable based on the provided information.

Summary

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K020627

MAY 0 6 2002

510(k) Summary Information:

Device Manufacturer:	Dade MicroScan Inc.
Contact name:	Cynthia Van Duker, Regulatory Affairs Manager
Fax:	916-374-3144
Date prepared:	February 25, 2002
Product Name:	Microdilution Minimum Inhibitory Concentration (MIC) Panels
Trade Name:	MicroScan® MICroSTREP plus™ Panel
Intended Use:	To determine bacterial susceptibility to Gatifloxacin
Indication for Use	For determining antimicrobic susceptibility with aerobic streptococci, includingStreptococcus pneumoniae
Predicate device:	MicroScan® Streptococcus MIC Panel (K963641).

510(k) Summary:

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 ul 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.

The proposed MicroScan® MICroSTREP plus™ Panel demonstrated substantially equivalent performance with streptococcal isolates 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 new MICroSTREP plus™ with Gatifloxacin.

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 MICroSTREP plus™ Panel by comparing its performance with an NCCLS frozen Reference panel. The MCroSTREP plus™ Panel demonstrated acceptable performance with an overall Essential Agreement of 100% for Gatifloxacin when compared with the frozen Reference panel.

Reproducibility testing demonstrated acceptable reproducibility and precision with Gatifloxacin.

Quality Control testing demonstrated acceptable results for Gatifloxacin.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the edge. Inside the circle is a stylized image of an eagle or bird-like figure, with three curved lines representing the body and wings.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

MAY 0 6 2002

Ms. Cynthia Van Duker Regulatory Affairs Manager Dade Behring Inc. 1584 Enterprise Boulevard West Sacramento, CA 95691

K020627 Re:

Trade/Device Name: MicroScan® MICroSTREP plus™ Panels with Gatifloxacin 0.06-8ug/ml

Regulation Number: 21 CFR 866.1640 Regulation Name: Antimicrobial Susceptibility Test Regulatory Class: Class II Product Code: LTT Dated: February 25, 2002 Received: February 26, 2002

Dear Ms. Van Duker:

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 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.

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.

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Page 2 -

This letter will allow you to begin marketing your device as described in your 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 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4588. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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,

Steven Butman

Steven I. Gutman, M.D., M.B.A. Director Division of Clinical Laboratory Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indication for Use Statement

510(k) No .:

(To be assigned by FDA)

Device Name:

Intended Use

Indications for Use:

K020627

MicroScan® MICroSTREP plus Panel

To determine bacterial antimicrobial agent susceptibility

This particular submission is for the addition of the antimicrobial Gatifloxacin at concentrations of 0.06 to 8 mcg/ml to the test panel

The organisms which may be used for Gatifloxacin susceptibility testing in this panel are;

Streptococcus pneumoniae Streptococcus pyogenes

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number	K020627

Prescription Use	Over-The-Counter Use
(Per 21 CFR 801.109)	OR

(Optional Format 1-2-96)

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).