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 Vancomvcin at concentrations of 0.06 to 8 mcg/ml to the test panel. The organisms which may be used for Vancomycin susceptibility testing in this panel are: Streptococcus pneumoniae (including penicillin-resistant strains), Streptococcus pyogenes, Streptococcus agalactiae, the viridans group, Streptococcus bovis.

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 (MC) 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 the study details for the MicroScan® MICroSTREP plus™ Panel with Vancomycin, based on the provided text:

Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Acceptance Criteria	Reported Device Performance (MicroScan® MICroSTREP plus™ Panel with Vancomycin)
Essential Agreement	Not explicitly stated as a percentage, but implied to be "acceptable performance" as defined by FDA DRAFT document "Guidance on Review Criteria for Assessment of Antimicrobial Susceptibility Devices", dated March 8, 2000. Typically, this refers to a high percentage agreement (e.g., >90-95%) between the candidate device and the reference method for MIC results.	99.5% for Vancomycin (when compared with the frozen Reference panel).
Reproducibility	Implied to be "acceptable"	Demonstrated acceptable reproducibility and precision with Vancomycin.
Quality Control	Implied to be "acceptable"	Demonstrated acceptable results for Vancomycin.

Study Details

Sample size used for the test set and the data provenance:
- Sample Size: Not explicitly stated as a number. The text mentions "fresh and stock Efficacy isolates and stock Challenge strains" were used for external evaluation.
- Data Provenance: Not explicitly stated (e.g., country of origin). It's a "Premarket Notification (510/k])" which implies internal company evaluation and then submission to the FDA. The nature of the isolates (fresh, stock, challenge) suggests a mix, potentially collected over time or specifically prepared.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Number of Experts: Not specified.
- Qualifications of Experts: Not specified.
Adjudication method for the test set:
- Not applicable/Not described. The ground truth appears to be based on an "NCCLS frozen Reference Panel," which acts as the comparator, rather than a human consensus adjudication process for the test results. The device results are compared against this reference, not human expert reads of the device itself.
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:
- No MRMC comparative effectiveness study was done. This device is an in vitro diagnostic (IVD) panel for determining antimicrobial susceptibility, not an AI-assisted diagnostic tool for human readers. The "reading" is visual observation of growth inhibition from the panel, not an interpretation of medical images or complex data by human readers.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- This is an in vitro diagnostic (IVD) panel. The "algorithm" is the biochemical process within the panel and the visual interpretation rules. The performance reported (Essential Agreement, Reproducibility, Quality Control) is inherently the device's performance in generating results that are then visually read by a human. While the final interpretation is human-dependent, the device itself is designed to produce a quantitative result (MIC), and the reported performance reflects its accuracy in doing so compared to a reference standard. Therefore, in a sense, the "standalone" or intrinsic performance of the panel's ability to produce the correct MIC is what was evaluated against the reference.
The type of ground truth used:
- NCCLS frozen Reference Panel. This is a recognized standard for antimicrobial susceptibility testing, considered a gold standard (or a very high-quality reference standard) for comparing new susceptibility testing methods.
The sample size for the training set:
- Not applicable/Not described. This device is a biochemical in vitro diagnostic panel, not a machine learning algorithm that requires a training set.
How the ground truth for the training set was established:
- Not applicable. As this is not a machine learning algorithm, there is no training set or associated ground truth establishment method.

Summary

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K020822

MAY 0 8 2002

510(k) Summary Information:

Device Manufacturer:	Dade MicroScan Inc.
Contact name:	Cynthia Van Duker, Regulatory Affairs Manager
Fax:	916-374-3144
Date prepared:	March 12, 2002
Product Name:	Microdilution Minimum Inhibitory Concentration (MIC) Panels
Trade Name:	MicroScan® MICroSTREP plus ™ Panel
Intended Use:	To determine bacterial susceptibility to Vancomycin
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 (MC) 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 Vancomycin.

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 MCCroSTREP plus™ Panel demonstrated acceptable performance with an overall Essential Agreement of 99.5% for Vancomycin when compared with the frozen Reference panel.

Reproducibility testing demonstrated acceptable reproducibility and precision with Vancomycin.

Quality Control testing demonstrated acceptable results for Vancomycin.

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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 stylized eagle with three lines representing its body and wings. The eagle is facing right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

MAY 0 8 2002

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

Re: K020822

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

Regulation Number: 21 CFR 866.1640 Regulation Name: Antimicrobial Susceptibility Test Regulatory Class: Class II Product Code: JWY Dated: March 12, 2002 Received: March 13, 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 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.:

Device Name:

Intended Use

Indications for Use:

KOZO822 (To be assigned by FDA)

MicroScan® MICroSTREP plus™ Panel

To determine bacterial antimicrobial agent susceptibility

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

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

Streptococcus pneumoniae (including penicillin-resistant strains) Streptococcus pyogenes Streptococcus agalactiae the viridans group Streptococcus bovis

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	K02 0822
Prescription Use	✓
(Per 21 CFR 801.109)	OR
	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).