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 Ceftriaxone at concentrations of 0.015 to 8 mcg/ml to the test panel

The organisms which may be used for Ceftriaxone susceptibility testing in this panel are:
Streptococcus pneumoniae
Streptococcus pyogenes
viridans group streptococci

Device Description

The MicroScan® MICroSTREP plus™ 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% bysed 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 intended to determine bacterial susceptibility to Ceftriaxone. The study aimed to demonstrate substantial equivalence to an NCCLS frozen Reference Panel.

1. Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Overall Essential Agreement with NCCLS frozen Reference panel	97.5% for Ceftriaxone
Reproducibility	Acceptable
Quality Control	Acceptable

Essential Agreement (EA): This typically means that the MIC result of the device is within one doubling dilution of the reference method's MIC result. The FDA DRAFT document "Guidance on Review Criteria for Assessment of Antimicrobial Susceptibility Devices", dated March 8, 2000, defines the specific criteria for acceptable performance. The 97.5% Essential Agreement indicates that the device's results are very close to the reference standard for Ceftriaxone.

2. Sample Size and Data Provenance

Test Set Sample Size: The document mentions "external evaluation was conducted with fresh and stock Efficacy isolates and stock Challenge strains". However, the exact number of isolates/strains used in the test set is not explicitly stated.
Data Provenance: The study was an "external evaluation," meaning it was likely conducted independently from the device manufacturer to ensure impartiality. The data provenance is not specified by country, but it adheres to FDA guidelines, implying a US regulatory context for the study design and evaluation. The data included both fresh isolates (prospective collection) and stock isolates/strains (likely retrospective or historical collections).

3. Number of Experts and Qualifications for Ground Truth

The document does not explicitly state the number of experts used or their detailed qualifications for establishing the ground truth. However, the ground truth was established by comparing the device's performance against an "NCCLS frozen Reference Panel." The NCCLS (National Committee for Clinical Laboratory Standards, now Clinical and Laboratory Standards Institute - CLSI) sets recognized standards for antimicrobial susceptibility testing. The processes for maintaining and evaluating these reference panels would involve highly qualified microbiologists and laboratory professionals.

4. Adjudication Method

The document does not explicitly mention an adjudication method for the test set. Given that the comparison is against an NCCLS frozen Reference Panel, the reference panel itself serves as the agreed-upon gold standard, and individual results are compared directly to this standard. Discrepancies would typically be analyzed against established NCCLS criteria rather than through a separate adjudication panel for each case.

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

There is no mention of a multi-reader multi-case (MRMC) comparative effectiveness study or any effect size of human readers improving with AI vs. without AI assistance. This device is a semi-automated system for determining Minimum Inhibitory Concentration (MIC) and involves visual reading, but the study focuses on the accuracy of the panel itself against a reference method rather than reader performance with or without AI assistance.

6. Standalone (Algorithm Only) Performance

The study primarily focuses on the standalone performance of the MicroScan® MICroSTREP plus™ Panel itself. It compares the device's MIC results to those of the NCCLS frozen Reference Panel. While the visual reading component involves human interpretation, the "acceptable performance with an overall Essential Agreement of 97.5% for Ceftriaxone" refers to the system's ability to produce accurate MIC values when interpreted according to its instructions. No human-in-the-loop enhanced performance is discussed as a separate variable.

7. Type of Ground Truth Used

The ground truth used was expert consensus (reference method), specifically the results obtained from an NCCLS frozen Reference Panel. This type of ground truth is a well-established and accepted standard in clinical microbiology for evaluating antimicrobial susceptibility testing devices.

8. Sample Size for the Training Set

The document does not specify a separate training set or its sample size. The study describes an "external evaluation" conducted to confirm acceptability by comparing performance with the NCCLS frozen Reference Panel, which typically refers to a validation or test set rather than a training set for model development.

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

As no specific training set is mentioned as part of this device submission, the method for establishing its ground truth is not described. The focus of the provided information is on the reference standard used for validating the device's performance.

Summary

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6 2002 Jun

Image /page/0/Picture/1 description: The image shows handwritten text that appears to be a code or identifier. The text includes the letters 'K' and 'O', followed by the numbers '2', '1', '1', and '0'. There is also a circle-like shape at the end of the text. The text is slightly tilted.

510(k) Summary Information:

Device Manufacturer:	Dade MicroScan Inc.
Contact name:	Cynthia Van Duker, Regulatory Affairs Manager
Fax:	916-374-3144
Date prepared:	April 3, 2002
Product Name:	Microdilution Minimum Inhibitory Concentration (MIC) Panels
Trade Name:	MicroScan® MICroSTREP plus™ Panel
Intended Use:	To determine bacterial susceptibility to Ceftriaxone
Indication for Use	For determining antimicrobic susceptibility with aerobic streptococci, includingStreptococcus pneumoniae
Predicate device:	MicroScan® Streptococcus MIC Panel (K963641).

510(k) Summary:

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 Ceftriaxone.

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 97.5% for Ceftriaxone when compared with the frozen Reference panel.

Reproducibility testing demonstrated acceptable reproducibility and precision with Ceftriaxone.

Quality Control testing demonstrated acceptable results for Ceftriaxone.

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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 seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is an abstract symbol that resembles three stylized human figures or birds in flight, arranged in a row.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

6 2002 JUN

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

Re: K021110

Trade/Device Name: MicroScan® MICroSTREP plus™ Panels Antimicobial agent: Ceftriaxone Regulation Number: 21 CFR 866.1640 Regulation Name: Antimicrobial Susceptibility Test System Regulatory Class: Class II Product Code: JWY Dated: April 3, 2002 Received: April 5, 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

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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/cdrb/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.:	KOZ1110(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 determinequantitative and/or qualitative antimicrobial agent susceptibility ofcolonies grown on solid media of aerobic streptococci, includingStreptococcus pneumoniae . After inoculation, panels are incubatedfor 20 - 24 hours at 35°C +/- 1°C in a non-CO2 incubator, andread visually according to the Package Insert.
	This particular submission is for the addition of the antimicrobialCeftriaxone at concentrations of 0.015 to 8 mcg/ml to the test panel
	The organisms which may be used for Ceftriaxone susceptibilitytesting in this panel are:
	Streptococcus pneumoniaeStreptococcus pyogenesviridans 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
310(k) Number	K021110
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).