The MicroScan® Dried Gram-Positive MIC/Combo Panel is used to determine quantitative and/or qualitative antimicrobial agent susceptibility of colonies grown on solid media of rapidly growing aerobic and facultative anaerobic gram-positive cocci. After inoculation, panels are incubated for 16-20 hours at 35°C +/- 1°C in a non-CO2 incubator, and read either visually or with MicroScan instrumentation, according to the Package Insert.

This submission is to evaluate the performance of the antimicrobial agent Erythromycin on the MicroScan® Dried Gram-Positive MIC/Combo Panels read on MicroScan® WalkAway and autoSCAN-4 Instruments utilizing the current DMS or LabPro version <2.0 Software platforms.

The Gram-Positive organisms which may be used for Erythromycin susceptibility testing in this panel are:

Staphylococcus aureus

Device Description

Not Found

AI/ML Overview

The provided text describes the 510(k) premarket notification for the MicroScan® Dried Gram-Positive MIC/Combo Panels with Erythromycin. This document is focused on the regulatory approval rather than a detailed study report with all the specific elements requested for acceptance criteria and study design.

However, based on the information provided, we can infer some details and highlight what is explicitly stated:

1. Table of Acceptance Criteria and Reported Device Performance & 7. Type of Ground Truth Used:

The document mentions that the submission is "to evaluate the performance of the antimicrobial agent Erythromycin." In the context of antimicrobial susceptibility testing (AST) devices, the primary acceptance criteria typically revolve around the agreement between the new device's readings and a reference method (the "ground truth"). This agreement is often measured in terms of Essential Agreement (EA) and Category Agreement (CA). For AST devices, the ground truth is usually established by a recognized reference method, such as broth microdilution or agar dilution, often performed manually.

While the specific numerical acceptance criteria (e.g., "≥90% EA") and the reported performance (e.g., "95% EA") are not explicitly stated in this regulatory letter, they would have been part of the underlying study submitted to the FDA.

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

Test Set Organism: The document explicitly states that the organisms used for Erythromycin susceptibility testing in this panel are: Staphylococcus aureus.
Sample Size: The exact number of Staphylococcus aureus isolates used for the test set is not specified in the provided text.
Data Provenance: The provenance (e.g., country of origin, retrospective or prospective) of the data is not specified in the provided text.

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

This information is not specified in the provided text. For AST devices, the "experts" are typically the trained microbiologists or laboratory personnel who perform and interpret the reference method.

4. Adjudication method for the test set:

This information is not specified in the provided text. For AST, adjudication is less about expert consensus on image interpretation and more about resolving discrepancies between the device and the reference method, possibly through re-testing or using an alternative reference method.

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:

This is not applicable to this device. This is an antimicrobial susceptibility testing device, read either visually or with instrumentation. There is no AI component or human-in-the-loop "reading" in the sense of medical imaging interpretation that would warrant an MRMC study comparing human readers with and without AI assistance. The "readers" here are either the instruments (MicroScan® WalkAway and autoSCAN-4) or a human visually interpreting the panel.

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

Yes, this is effectively a standalone performance evaluation. The device (MicroScan® Dried Gram-Positive MIC/Combo Panels) in conjunction with the MicroScan® WalkAway and autoSCAN-4 Instruments and associated software (DMS or LabPro version <2.0) is being evaluated for its ability to determine susceptibility independently. While visual reading is an option, the submission specifically mentions the instrument-based readings, which represent a standalone algorithm/instrument performance. The comparison would be against a reference method, not against human readers.

8. The sample size for the training set:

The training set sample size is not specified in the provided text. For AST devices, "training" might refer to isolates used during the development and optimization of the panel and instrument reading algorithms, but this detail is not present in the regulatory letter.

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

This information is not specified in the provided text. Similar to the test set, the ground truth for any training set would typically be established using a recognized reference AST method.

Summary

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus symbol.

Public Health Service

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

AUG 2 3 2006

Ms. Shannon Popson Regulatory Affairs Manager Dade Behring 1584 Enterprise Boulevard West Sacramento, CA 95691-9972

Re: K062179

Trade/Device Name: MicroScan® Dried Gram-Positive MIC/Combo Panels with Erythromycin (0.25 - 16 ug/ml) Regulation Number: 21 CFR 866.1640 Regulation Name: Antimicrobial Susceptibility Test Regulatory Class: II Product Code: LRG Dated: July 24, 2006 Received: July 31, 2006

Dear Ms. Popson:

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. Iisting 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 Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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 Parts 801 and 809); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).

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This letter will allow you to begin marketing your device as described in your Section 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 information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (240)276-0450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 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,

Sally, artom

Sally A. Hojvat, M.Sc., Ph.D. Director Division of Microbiology Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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Indications For Use Statement

Page 1 of 1.

510(k) Number (if known):

MicroScan® Dried Gram-Positive MIC/Combo Panels with Erythromycin Device Name: (0.25 - 16 µg/ml)

Indications For Use:

The Gram-Positive organisms which may be used for Erythromycin susceptibility testing in this panel are:

Staphylococcus aureus

Prescription Use _____________________________________________________________________________________________________________________________________________________________ > (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

gnostic Devices (OIVD)

Division Sign Off

ivision Sign-Off

Office of In Vito Diagnostic Device Evaluation and Satery

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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).