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 details for the MicroScan® MICroSTREP plus™ Panel with Clindamycin, based on the provided text:

Acceptance Criteria and Device Performance

Acceptance Criteria	Reported Device Performance
Overall Essential Agreement (compared to NCCLS frozen Reference Panel)	96.2% for Clindamycin
Reproducibility	Acceptable reproducibility and precision for Clindamycin
Quality Control	Acceptable results for Clindamycin

Note: The document states that the performance was reviewed against the "FDA DRAFT document "Guidance on Review Criteria for Assessment of Antimicrobial Susceptibility Devices", dated March 8, 2000." This implies that the 96.2% Essential Agreement met the acceptance threshold defined in that guidance document. Specific numeric thresholds for reproducibility and quality control are not explicitly stated but are implied to have been met with "acceptable" results.

Study Details

2. Sample size used for the test set and the data provenance

Test Set Sample Size: Not explicitly stated as a single number. The external evaluation was conducted with "fresh and stock Efficacy isolates and stock Challenge strains." The text doesn't specify the total number of isolates used in these categories combined for the Clindamycin evaluation.
Data Provenance: Not explicitly stated (e.g., country of origin). The study involved "external evaluation," suggesting the data was collected from multiple sites beyond the manufacturer's internal labs. It was a prospective study in the sense that the new device's performance was compared to a reference method, but the isolates themselves could be either retrospectively collected "stock" or prospectively collected "fresh."

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. This device determines antimicrobial susceptibility, where the "ground truth" is established by a reference laboratory method (NCCLS frozen Reference Panel), not by human expert interpretation of images or clinical data.

4. Adjudication method for the test set

Not applicable. As the ground truth is established by a reference laboratory method, there is no need for expert adjudication.

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 is an in vitro diagnostic device for determining microbial susceptibility. It does not involve human readers interpreting cases or AI assistance in that context. The "reading" is manual observation of an MIC for the test organism in the panel.

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

The device is described as being "read visually according to the Package Insert" to observe the "lowest antimicrobial concentration showing inhibition of growth." This indicates a human-in-the-loop process for reading the results. The "device" itself (the panel) is a diagnostic assay, and its performance is assessed based on the accuracy of the manual reading compared to the reference. There is no "algorithm only" performance reported in this context.

7. The type of ground truth used

The ground truth was an NCCLS frozen Reference Panel. This is a recognized standard laboratory method for determining antimicrobial susceptibility.

8. The sample size for the training set

Not applicable. This is a microbiology susceptibility test panel, not an AI/machine learning algorithm that requires a "training set" in the conventional sense. The "development" of the panel involves formulating the dilutions and components, not training a model.

9. How the ground truth for the training set was established

Not applicable, as there is no "training set" or AI algorithm involved.

Summary

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JUN 2 0 2002

510(k) Summarv Information:

Device Manufacturer:	Dade MicroScan Inc.
Contact name:	Cynthia Van Duker, Regulatory Affairs Manager
Fax:	916-374-3144
Date prepared:	April 12, 2002
Product Name:	Microdilution Minimum Inhibitory Concentration (MIC) Panels
Trade Name:	MicroScan® MICroSTREP plus™ Panel
Intended Use:	To determine bacterial susceptibility to Clindamycin
Indication for Use	For determining antimicrobic susceptibility with aerobic streptococci, otherthan 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 MCroSTREP plus™ Panel with Clindamycin.

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 96.2% for Clindamycin when compared with the frozen Reference panel.

Reproducibility testing demonstrated acceptable reproducibility and precision with Clindamycin.

Quality Control testing demonstrated acceptable results for Clindamycin.

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K021184

JUN 2 0 2002

510(k) Summary Information:

Device Manufacturer:	Dade MicroScan Inc.
Contact name:	Cynthia Van Duker, Regulatory Affairs Manager
Fax:	916-374-3144
Date prepared:	April 12, 2002
Product Name:	Microdilution Minimum Inhibitory Concentration (MIC) Panels
Trade Name:	MicroScan® MICroSTREP plus™ Panel
Intended Use:	To determine bacterial susceptibility to Clindamycin
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 Premarket Notification (510/k]) presents data in support of the new MICroSTREP plus™ with Clindamycin.

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 MICroSTREP plus™ Panel demonstrated acceptable performance with an overall Essential Agreement of 96.2% for Clindamycin when compared with the frozen Reference panel.

Reproducibility testing demonstrated acceptable reproducibility and precision with Clindamycin.

Quality Control testing demonstrated acceptable results for Clindamycin.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, resembling a bird in flight.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

JUN 2 0 2002

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

Re: K021184

Trade/Device Name: MicroScan® MICroSTREP plus™ Panel For Clindamycin 0.015-2ug/ml Regulation Number: 21 CFR 866.1640 Regulation Name: Antimicrobial Susceptibility Test Regulatory Class: Class II Product Code: LTT Dated: April 12, 2002 Received: April 15, 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 1 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 Putman

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.:	K021184(To be assigned by FDA)
Device Name:	MicroScan ® MICroSTREP plus™ Panel
Intended Use	To determine bacterial antimicrobial agent susceptibility
Indications for Use:	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 Clindamycin at concentrations of 0.015 to 2 mcg/ml to the test panel
	The organisms which may be used for Clindamycin susceptibility testing in this panel are:
	Streptococci
	The MicroScan ® MICroSTREP plus™ Panel with Clindamycin is not intended for use with:
	Streptococcus pneumoniae

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Woody Dubves(Division Sign-Off)
Division of Clihical Laboratory Devices KO21184 510(k) Number_

Prescription Use
(Per 21 CFR 801.109)

Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________

(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).