To determine bacterial antimicrobial agent susceptibility. For use with aerobic non-enterococcal streptococci including S. pneumoniae. The MicroScan® MICroSTREP plus™ Panel is used to determine antimicrobial susceptibility of aerobic non-enterococcal streptococci, including Streptococcus pneumoniae. After inoculation, panels are incubated for 20-24 hours at 35℃ +/- 1℃ in a non-CO2 incubator, and read visually according to the Package Insert. This particular submission is for the addition of the antimicrobial AMOXICILLIN at concentrations of 0.008 - 16 mcg/ML to the test panel. The organisms which may be used for AMOXICILLIN susceptibility testing in this panel are; Streptococcus pneumoniae.

Device Description

Microdilution Minimum Inhibitory Concentration (MIC) Panels. MicroScan® MICroSTREP plus™ Panel - Amoxicillin.

AI/ML Overview

Here's an analysis of the provided text, outlining the acceptance criteria and study details for the Dade Behring MicroScan® MICroSTREP plus™ Panel - Amoxicillin:

The provided document describes the submission and FDA clearance for the Dade Behring MicroScan® MICroSTREP plus™ Panel, specifically for the addition of Amoxicillin. The core of the study is a comparison between the new device and a predicate device (NCCLS Frozen Reference Panels) to demonstrate "substantial equivalence."

Acceptance Criteria and Reported Device Performance

The document states that the acceptance criterion for the device's performance is "acceptable Essential Agreement performance" when compared to the frozen Reference panel. While specific numerical targets for Essential Agreement are not explicitly stated within the provided text, the FDA's "Review Criteria for Assessment of Antimicrobial Susceptibility Devices" (dated May 31, 1991) is referenced as the guiding document for defining acceptable performance. For reproducibility testing, the criterion was "acceptable reproducibility and precision." Similarly, for Quality Control, the criterion was "acceptable results."

Acceptance Criteria Category	Specific Metric (as implied or referenced)	Acceptance Criterion	Reported Device Performance
Comparative Performance	Essential Agreement (vs. NCCLS Frozen Reference Panels)	"acceptable Essential Agreement performance" as defined by FDA DRAFT document "Review Criteria for Assessment of Antimicrobial Susceptibility Devices" (dated May 31, 1991)	Demonstrated "acceptable Essential Agreement performance"
Reproducibility	Reproducibility and Precision	"acceptable reproducibility and precision"	Demonstrated "acceptable reproducibility and precision"
Quality Control	N/A (General QC standards)	"acceptable results"	Demonstrated "acceptable results"

Study Details

Sample size used for the test set and the data provenance:
- Sample Size: Not explicitly stated with a numerical value. The document mentions "fresh and stock Efficacy isolates and stock Challenge strains" were used for the external evaluation.
- Data Provenance: Not explicitly stated, though the manufacturer is based in West Sacramento, CA, suggesting the study was likely conducted in the US. The isolates themselves could have varied origins.
- Retrospective or Prospective: Not explicitly stated. Given the use of "fresh and stock Efficacy isolates and stock Challenge strains," it likely involved elements of both, with "fresh" isolates suggesting prospective collection and "stock" isolates being retrospective.
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. The ground truth was established by comparison to NCCLS Frozen Reference Panels, which themselves represent a gold standard for susceptibility testing, implying expert-derived methodologies.
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Adjudication Method: Not explicitly stated. The comparison is against a "Reference panel," which generally serves as the definitive result rather than requiring further human adjudication for discrepancies between methods.
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:
- MRMC Study: No, an MRMC study was not performed. This device is an in-vitro diagnostic (IVD) antimicrobial susceptibility test, not an AI-assisted diagnostic imaging device that typically involves human readers interpreting cases. Therefore, the concept of "human readers improve with AI vs without AI assistance" is not applicable here.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Standalone Performance: Yes, in essence, the "external evaluation" against the NCCLS Frozen Reference Panel is a standalone performance assessment of the new MicroScan panel. It assesses the panel's ability to accurately determine MIC values and susceptibility categories independently, without human interpretation influencing the primary measurement of MIC. However, it's important to note that the instruction states "read visually according to the Package Insert," implying a human reading step for the MicroScan panel. The "standalone" here refers to the algorithm's performance in the context of generating the MIC, not necessarily a fully automated system from specimen to result without any human interaction.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Type of Ground Truth: The ground truth was established by NCCLS Frozen Reference Panels. These panels are considered the gold standard for antimicrobial susceptibility testing, representing a highly standardized and validated method, effectively serving as an expert-derived and experimentally confirmed ground truth.
The sample size for the training set:
- Sample Size for Training Set: The document does not explicitly mention a "training set" or its size in the context of machine learning. This device predates widespread AI/ML applications in IVD. The data cited ("fresh and stock Efficacy isolates and stock Challenge strains") appears to be for the evaluation/test of the device's performance, not for training a model.
How the ground truth for the training set was established:
- How Ground Truth for Training Set was Established: Not applicable, as a distinct training set (in the ML sense) is not described or implied for this device. The development of the MicroScan panel itself would have relied on established microbiological principles and validation methods to ensure its accuracy against known microbial responses, which informally serve as "ground truth" for its design.

Summary

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DEC - 9 1999

Dade Behring

DADE MICROSCAN INC. 1584 Enterprise Boulevard West Sacramento, CA 95691 Tel: +1 (916) 372-1900

510(k) Summary Information:

Device Manufacturer:	Dade MicroScan Inc.
Contact name:	Sharolyn Lentsch, Regulatory Affairs Manager
Fax:	916-374-3144
Date prepared:	October 22, 1998
Product Name:	Microdilution Minimum Inhibitory Concentration (MIC) Panels
Trade Name:	MicroScan® MICroSTREP plus™ Panel - Amoxicillin
Intended Use:	To determine bacterial antimicrobial agent susceptibility
Indication for Use	For use with aerobic non-enterococcal streptococci including S. pneumoniae
Predicate device:	NCCLS Frozen Reference Panels

510(k) Summary:

The proposed MicroScan® MICroSTREP plusTM Panel demonstrated substantially equivalent performance with streptococcal isolates when compared with an NCCLS frozen Reference Panel, as defined in the FDA DRAFT document "Review Criteria for Assessment of Antimicrobial Susceptibility Devices" (dated May 31, 1991).

The Premarket Notification (510[k]) presents data in support of the new MICroSTREP plus™ Panel with various antimicrobial agents.

The external evaluation was conducted with fresh and stock Efficacy isolates and stock Challenge strains. The MICroSTREP plus™ Panel demonstrated acceptable Essential Agreement performance when compared with the frozen Reference panel.

Reproducibility testing demonstrated acceptable reproducibility and precision with each of the antimicrobial agents tested.

Quality Control testing demonstrated acceptable results for each of the antimicrobial agents tested.

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Image /page/1/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features the department's name encircling a symbol. The symbol consists of three stylized human figures or shapes that are interconnected. The figures are arranged in a way that suggests movement or progress.

DEC - 9 1999

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Mr. Trevor Wall Regulatory Affairs Manager Dade MicroScan, Inc. 1584 Enterprise Boulevard West Sacramento, California 95691

Re: K983746

Trade Name: MicroScan® MICroSTREP plus™ Panel (AMOXICILLIN) Regulatory Class: II Product Code: JWY Dated: October 1, 1999 Received: October 4, 1999

Dear Mr. Wall:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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Page 2

Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA-88), this device may require a CLIA complexity categorization. To determine if it does, you should contact the Centers for Disease Control and Prevention (CDC) at (770)488-7655.

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 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" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll free number (800) 638-2041 or at (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/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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Page Ol

510(k) Number (if known): 长 98 3746

Device Name: MICroSTRED plus To pares - AMOXIC illio

Indications For Use:

The MicroScan® MICroSTREP plus™ Panel is used to determine antimicrobial susceptibility of aerobic non-enterococcal streptococci, including Streptococcus pneumoniae. After inoculation, panels are incubated for 20-24 hours at 35℃ +/- 1℃ in a non-CO2 incubator, and read visually according to the Package Insert.

This particular submission is for the addition of the antimicrobial AMOXICILLIN at concentrations of 0.008 - 16 mcg/ML to the test panel

The organisms which may be used for AMOXICILLIN susceptibility testing in this panel are;

Streptococcus pneumoniae

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Woodei Deebois

Division of Clifical Laboratory Devices 510(k) Number_198374

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).