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 Cefepime at concentrations of 0.015 to 8 mcg/ml to the test panel. The organisms which may be used for Cefepime susceptibility testing in this panel are: Streptococcus pneumoniae, Streptococcus pyogenes (Lancefield's Group A streptococci), Streptococcus agalactiae (Lancefield's Group B streptococci), Viridans group streptococci.

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 study information for the MicroScan® MICroSTREP plus™ Panel with Cefepime, based on the provided text:

Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Overall Essential Agreement	96.3% for Cefepime when compared with the frozen Reference panel
Reproducibility	Acceptable reproducibility and precision with Cefepime
Quality Control	Acceptable results for Cefepime

Study Details

Sample size used for the test set and the data provenance:
- Test Set Size: Not explicitly stated as a number, but the evaluation was conducted with "fresh and stock Efficacy isolates and stock Challenge strains."
- Data Provenance: The external evaluation was conducted to compare performance with an "NCCLS frozen Reference Panel." The origin of the actual bacterial isolates (countries, etc.) is not specified, nor is whether the data was retrospective or prospective. It is implied to be prospective for the purpose of the study.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This information is not provided in the document. The ground truth was established by comparing the device performance to an "NCCLS frozen Reference Panel," which acts as the gold standard, but details on how that reference panel's "ground truth" was initially established (e.g., how many experts, their qualifications, etc.) are absent.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- This information is not provided in the document. The comparison was made directly against the NCCLS frozen Reference Panel, suggesting no explicit human adjudication process for the test results themselves beyond the visual reading specified for the device.
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. This is not an AI device. It's an in vitro diagnostic device (microdilution panel) for antimicrobial susceptibility testing. The readings are described as "manually read by observing." Therefore, an MRMC study related to AI assistance is not applicable.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- No. The device requires human interaction ("manually read by observing the lowest antimicrobial concentration showing inhibition of growth"). It is not a standalone algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- The ground truth was established by an NCCLS frozen Reference Panel. This reference panel serves as the accepted standard for determining minimum inhibitory concentrations (MICs). This is a form of reference standard comparative data, where the new device's results are compared to a well-established and validated method.
The sample size for the training set:
- The document primarily describes an external evaluation or test set that compared the device to a reference panel. It does not explicitly mention a separate training set or its size. Microdilution panels like this are generally developed based on established microbiological principles rather than machine learning training sets.
How the ground truth for the training set was established:
- Since a distinct "training set" in the context of machine learning is not described for this device, information on how its ground truth was established is not applicable/provided. The development of these types of panels typically relies on extensive historical microbiological data and standardized methodologies to determine appropriate antimicrobial concentrations and efficacy.

Summary

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6 2002 וחות

510(k) Summary Information:

Device Manufacturer:	Dade MicroScan Inc.
Contact name:	Cynthia Van Duker, Regulatory Affairs Manager
Fax:	916-374-3144
Date prepared:	April 10, 2002
Product Name:	Microdilution Minimum Inhibitory Concentration (MIC) Panels
Trade Name:	MicroScan® MICroSTREP plus™ Panel
Intended Use:	To determine bacterial susceptibility to Cefepime
Indication for Use	For determining antimicrobic susceptibility with aerobic streptococci, including
	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 (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 MICroSTREP plus™ Panel with Cefepime.

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 96.3% for Cefepime when compared with the frozen Reference panel.

Reproducibility testing demonstrated acceptable reproducibility and precision with Cefepime.

Quality Control testing demonstrated acceptable results for Cefepime.

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ood amdi Druxo Administrati 8 Garther Rosar dkville MD 20850

6 2002 JUN -

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

K021188 Re:

Trade/Device Name: MicroScan® MICroSTREP plus™ Panels Microbial agent: Cefepime 0.15-8ug/ml Regulation Number: 21 CFR 866.1640 Regulation Name: Antimicrobial Susceptibility Test Regulatory Class: Class II Product Code: JWY Dated: April 10, 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 (OS) 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:

KO21188 (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 Cefepime at concentrations of 0.015 to 8 mcg/ml to the test panel

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

Streptococcus pneumoniae Streptococcus pyogenes (Lancefield's Group A streptococci) Streptococcus agalactiae (Lancefield's Group B streptococci) Viridans group streptococci

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
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Prescription Use	/
(Per 21 CFR 801.109)

510(k) Number	K02 1188
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Over-The-Counter Use	_________________
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(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).