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 Ampicillin at concentrations of 0.03 to 16 mcg/ml to the test panel. The organisms which may be used for Ampicillin susceptibility testing in this panel are: Streptococcus spp. other than Streptococcus pneumoniae.

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

Here's a breakdown of the acceptance criteria and study information for the MicroScan® MICroSTREP plus™ Panel with Ampicillin, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria	Reported Device Performance
Overall Essential Agreement for Ampicillin (compared to NCCLS frozen Reference panel)	93.4%
Reproducibility and Precision for Ampicillin	Acceptable
Quality Control Testing for Ampicillin	Acceptable

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" were used for the external evaluation. However, the exact sample size (number of isolates/strains) for the test set is not explicitly stated in the provided text.
Data Provenance: The data was generated through an "external evaluation," implying independent testing. The text does not specify the country of origin of the data, but the context implies it was likely conducted in the US given the FDA submission. The study involved both "fresh" isolates (suggesting prospective collection at that time) and "stock" isolates/strains (suggesting retrospective use of stored samples).

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

The document states the proposed device's performance was compared with an "NCCLS frozen Reference Panel." This implies that the ground truth was established by the NCCLS Reference Panel, which is a standardized method for antimicrobial susceptibility testing. The development and validation of such reference panels typically involve multiple experts and rigorous standardization, but the number and specific qualifications of experts involved in establishing the ground truth for this particular study's reference panel are not detailed in the provided text.

4. Adjudication Method for the Test Set:

The text describes a direct comparison of the MicroScan® MICroSTREP plus™ Panel with the NCCLS frozen Reference Panel. The "Essential Agreement" metric suggests a comparison of MIC values obtained by both methods. There is no mention of an overt adjudication method (like 2+1 or 3+1) involving human expert review for resolving discrepancies between the test device and the reference standard; the NCCLS reference method is treated as the established ground truth.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done:

No, a Multi Reader Multi Case (MRMC) comparative effectiveness study was not conducted as described in the provided text. The study focuses on comparing the new device's performance to a reference standard, not on the improvement of human readers with or without AI assistance. The device is a diagnostic panel, not an AI assistance tool for human interpretation.

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

Yes, a standalone performance evaluation was done. The MicroScan® MICroSTREP plus™ Panel itself is the device under test, and its performance is evaluated independently against a reference standard. While human visual reading is part of its intended use ("read visually according to the Package Insert"), the "Essential Agreement" comparison primarily assesses the panel's ability to produce consistent MIC results in comparison to the reference, representing its standalone analytical performance.

7. The Type of Ground Truth Used:

The type of ground truth used was an expert-established and standardized reference method: the "NCCLS frozen Reference Panel." NCCLS (National Committee for Clinical Laboratory Standards, now Clinical and Laboratory Standards Institute - CLSI) reference methods are considered the gold standard for antimicrobial susceptibility testing.

8. The Sample Size for the Training Set:

The document does not specify a separate "training set" or its sample size. The information provided is about the performance validation study (test set) of the final device. For a diagnostic panel like this, the "training" (development and optimization) would involve internal R&D processes of the manufacturer, and the details are not typically included in a 510(k) summary focused on validation.

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

As a training set is not explicitly mentioned or detailed in the provided text, the method for establishing its ground truth is unknown from this document.

Summary

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MAY 0 6 2002

K021037

510(k) Summary Information:

Device Manufacturer:	Dade MicroScan Inc.
Contact name:	Cynthia Van Duker, Regulatory Affairs Manager
Fax:	916-374-3144
Date prepared:	March 27, 2002
Product Name:	Microdilution Minimum Inhibitory Concentration (MIC) Panels
Trade Name:	MicroScan® MICroSTREP plus™ Panel
Intended Use:	To determine bacterial susceptibility to Ampicillin
Indication for Use:	For determining antimicrobic susceptibility with aerobic streptococci, other
	than Streptococcus 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™ Panel with Ampicillin.

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 93.4% for Ampicillin when compared with the frozen Reference panel.

Reproducibility testing demonstrated acceptable reproducibility and precision with Ampicillin.

Quality Control testing demonstrated acceptable results for Ampicillin.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/1/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal features a stylized caduceus symbol, which is often associated with healthcare. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the symbol.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

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

K021037 Re:

K021037
Trade/Device Name: MicroScan® MICroSTREP plus™ Panels with Ampicillin 0.03-16ug/ml

Regulation Number: 21 CFR 866.1640 Regulation Name: Antimicrobial Susceptibility Test Regulatory Class: Class II Product Code: JWY Dated: March 27, 2002 Received: April 1, 2002

Dear Ms. Van Duker:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your because be (s) pe device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encreate) to registered date of the Medical Device Amendments, or to conninered proc to May 20, 1978, in easily 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 r ou may, more coronisions of the Act include requirements for annual registration, listing of general oonavil proficturing 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 If your device is classino itional controls. Existing major regulations affecting your device can may or babyer to been as a seen as 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 r reaso oe active a made a determination that your device complies with other requirements of the Act that I Dri has intess and regulations administered by other Federal agencies. You must or any I edetail 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 v 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/odrh/dsma/dsmamain.html".

Sincerely yours,

Steven Sutman

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:

MicroScan® MICroSTREP plus™ Panel

To determine bacterial antimicrobial agent susceptibility

This particular submission is for the addition of the antimicrobial Ampicillin at concentrations of 0.03 to 16 mcg/ml to the test panel

The organisms which may be used for Ampicillin susceptibility testing in this panel are:

Streptococcus spp. other than Streptococcus pneumoniae

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Freddie L. Poole

(Division Sign-Off) (Division Sign-Olf)
Division of Clinical Laboratory Devices

510(k) Number K021037

Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________

Prescription Use (Per 21 CFR 801.109)

(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).