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. Panels are incubated for 16 – 20 hours at 35℃ +/- 1℃ in a non-CO2 incubator, and read either visually or with MicroScan instrumentation, according to the Package Insert.

This particular submission is for the addition of the antimicrobial Erythromycin at concentrations of 0.25 to 16 mcg/ml to the test panel.

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

Staphylococcus aureus

Device Description

MicroScan® Dried Gram-Positive MIC/Combo Panels are designed for use in determining quantitative and/or qualitative antimicrobial agent susceptibility of colonies grown on solid media of rapidly growing aerobic and facultative anaerobic gram-positive cocci.

The antimicrobial susceptibility tests are miniaturizations of the broth dilution susceptibility test that have been diluted in broth and dehydrated. Various antimicrobial agents are diluted in broth to concentrations bridging the range of clinical interest. Panels are rehydrated with water after inoculation with a standardized suspension of the organism. After incubation in a non-CO2 incubator for 16-20 hours, the minimum inhibitory concentration (MC) for the test organism is read by determining 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® Dried Gram-Positive MIC/Combo Panels with Erythromycin, based on the provided text:

1. Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Overall Essential Agreement (for comparison with NCCLS frozen Reference Panel)Defined in FDA document "Class II Special Controls Guidance Document: Antimicrobial Susceptibility Test (AST) Systems; Guidance for Industry and FDA", dated February 5, 2003.	>96% for Erythromycin when compared with the frozen Reference panel.
Reproducibility and Precision (Inoculum and Instrument)Acceptable reproducibility and precision for Erythromycin, regardless of inoculum method (Turbidity and Prompt) or instrument (autoSCAN-4® and WalkAway®).	Demonstrated acceptable reproducibility and precision with Erythromycin, regardless of which inoculum method (Turbidity and Prompt), or instrument (autoSCAN-4® and WalkAway®) was used.
Quality Control TestingAcceptable results for Erythromycin.	Demonstrated acceptable results for Erythromycin.

2. Sample Size and Data Provenance

Test Set:
- Sample Size: Not explicitly stated in the provided text. The evaluation was conducted with "fresh and stock Efficacy isolates and stock Challenge strains." The exact number of isolates/strains used is not provided.
- Data Provenance: Not explicitly stated. Given it's an "external evaluation" conducted in support of an FDA submission, it's likely multi-center data, but the specific countries of origin are not mentioned. The study was prospective in the sense that it was designed to confirm the acceptability of the proposed panel.

3. Number of Experts and Qualifications for Ground Truth (Test Set)

Number of Experts: Not explicitly stated.
Qualifications of Experts: Not explicitly stated. However, the ground truth was established by an "NCCLS frozen Reference Panel," which implies adherence to standards and expert-derived values, but no specific personnel details are given. The "Expected Results" for Challenge strains would also be based on established expert knowledge or prior testing.

4. Adjudication Method (Test Set)

Adjudication Method: Not explicitly stated. The comparison was primarily against an "NCCLS frozen Reference Panel" and "Expected Results" for challenge strains, serving as the benchmark. This suggests a direct comparison rather than a human adjudication process between different readers of the device.

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

Was an MRMC study done? No. This device is an automated in vitro diagnostic (IVD) test for antimicrobial susceptibility. The assessment is against a reference method and established quality control, not against human readers evaluating medical images or similar.

6. Standalone Performance Study

Was a standalone study done? Yes. The study directly assessed the performance of the MicroScan® Dried Gram-Positive MIC/Combo Panels with Erythromycin (the algorithm/device) against the NCCLS frozen Reference Panel. The reported "Essential Agreement of >96% for Erythromycin" is a measure of its standalone performance compared to the gold standard. Reproducibility and Quality Control testing also evaluate the device's intrinsic performance.

7. Type of Ground Truth Used

The ground truth used was:
- Reference Method Comparison: An "NCCLS frozen Reference Panel." This is a standardized, recognized method for determining antimicrobial susceptibility, considered the gold standard for comparison in these types of studies.
- Expected Results: For "stock Challenge strains," the panels were compared to "Expected Results determined prior to the evaluation." These expected results would be derived from pre-established, verified susceptibility profiles for those specific strains.

8. Sample Size for the Training Set

Sample Size: Not applicable. This summary describes the validation of a physical diagnostic panel (Microdilution MIC panel), not a machine learning algorithm that requires a "training set" in the conventional sense. The "training" for such a device involves formulation, manufacturing, and internal QC processes to ensure consistency and accuracy, rather than data-driven model training.

9. How Ground Truth for the Training Set Was Established

How Ground Truth Was Established: Not applicable, as there is no "training set" in the context of a machine learning algorithm. The panel's design and manufacturing are based on established microbiological principles for antimicrobial susceptibility testing, with the concentrations of antimicrobial agents diluted in broth to "concentrations bridging the range of clinical interest." The performance of the resulting panel is then validated against reference standards.

Summary

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MAR 2 9 2005

K050043

510(k) Summary

510(k) Submission Information:

Device Manufacturer:	Dade Behring, Inc.
Contact name:	Cynthia Van Duker, Regulatory Affairs Manager
Fax:	916-374-3144
Date prepared:	January 5, 2005
Product Name:	Microdilution Minimum Inhibitory Concentration (MIC) Panels
Trade Name:	MicroScan® Dried Gram-Positive MIC/Combo Panels
Intended Use:	To determine antimicrobial agent susceptibility
510(k) Notification:	New antimicrobial - Erythromycin
Predicate device:	MicroScan Dried Gram-Positive and Gram-Negative MIC/Combo Panels

510(k) Summary:

The proposed MicroScan® Dried Gram-Positive MIC/Combo Panel demonstrated substantially equivalent performance when compared with an NCCLS frozen Reference Panel, as defined in the FDA document "Class II Special Controls Guidance Document: Antimicrobial Susceptibility Test (AST) Systems; Guidance for Industry and FDA", dated February 5, 2003. The Premarket Notification (510[k]) presents data in support of the MicroScan® Dried Gram-Positive MIC/Combo Panel with Erythromycin.

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 Dried Gram-Positive Panel by comparing its performance with an NCCLS frozen Reference panel. Challenge strains were compared to Expected Results determined prior to the evaluation. The Dried Gram-Positive Panel demonstrated acceptable performance with an overall Essential Agreement of >96% for Erythromycin when compared with the frozen Reference panel.

Inoculum and instrument reproducibility testing demonstrated acceptable reproducibility and precision with Erythromycin, regardless of which inoculum method (i.e., Turbidity and Prompt), or instrument (autoSCAN-4® and WalkAway®) was used.

Quality Control testing demonstrated acceptable results for Erythromycin.

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Image /page/1/Picture/1 description: The image shows the seal of the Department of Health & Human Services USA. The seal features a stylized eagle-like symbol with three curved lines representing wings or feathers. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the symbol.

MAR 2 9 2005

Food and Druq Administration 2098 Gaither Road Rockville MD 20850

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

K050043 Re:

Trade/Device Name: MicroScan® Dried Gram-Positive MIC/Combo Panels with Erythromycin (0.25 - 16 mcg/ml) Regulation Number: 21 CFR 866.1640 Regulation Name: Antimicrobial susceptibility test powder Regulatory Class: Class II Product Code: LRG Dated: March 22, 2005 Received: March 24, 2005

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 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 mcan 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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Page 2 –

This letter will allow you to begin marketing your device as described in your Section 510(k) I mis lotter with anon. The FDA finding of substantial equivalence of your device to a legally premated newice 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)276-0484. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act 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/industry/support/index.html

Sincerely yours,

Sales a Story

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

510(k) Number (if known): Ko ≤ 0043/S /

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

Indications For Use:

The MicroScan® Dried Gram-Positive MIC/Combo Panel is used to determine r no fiferooval - E revelitative antimicrobial agent susceptibility of colonies grown on solid media of rapidly growing aerobic and facultative anaerobic gram-positive on sond media of rapies goods are incubated for 16 – 20 hours at 35℃ +/- 1℃ in a non-CO2 incubator, and read either visually or with MicroScan instrumentation, according to the Package Insert.

This particular submission is for the addition of the antimicrobial Erythromycin at concentrations of 0.25 to 16 mcg/ml to the test panel.

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

Staphylococcus aureus

____ لا__ 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)

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Office of In Vitro Diagnostic Device Evaluation and Safety

Ko 50043 /SI 510(k) -

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).