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℃ +/- 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 Ertapenem at concentrations of 0.002 to 32 mcg/ml to the test panel.

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

Staphylococcus aureus (methicillin-susceptible strains) Streptococcus agalactiae

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 (MIC) for the test organism is read by determining the lowest antimicrobial concentration showing inhibition of growth.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the MicroScan® Dried Gram-Positive MIC/Combo Panels with Ertapenem:

Acceptance Criteria and Study for MicroScan® Dried Gram-Positive MIC/Combo Panels with Ertapenem

1. Table of Acceptance Criteria and Reported Device Performance

The device's performance is assessed against the criteria outlined in the FDA's "Class II Special Controls Guidance Document: Antimicrobial Susceptibility Test (AST) Systems; Guidance for Industry and FDA." The key metric mentioned is "Essential Agreement."

Acceptance Criteria	Reported Device Performance
Essential Agreement	>96% for Ertapenem

2. Sample Size and Data Provenance

Test Set Sample Size: The exact number of isolates used in the external evaluation is not explicitly stated. However, it is mentioned that the evaluation was conducted with "fresh and stock Efficacy isolates and stock Challenge strains."
Data Provenance: The text does not specify the country of origin for the data. The study was an "external evaluation," implying it was conducted independently of the manufacturer, but the location is not provided. The study included both "fresh" and "stock" isolates, indicating a mix of prospective (fresh) and retrospective (stock) data collection.

3. Number and Qualifications of Experts for Ground Truth

The document does not explicitly state the number or qualifications of experts used to establish the ground truth. It refers to an "NCCLS frozen Reference Panel" and "Expected Results determined prior to the evaluation" for challenge strains, implying established reference methods and data rather than real-time expert interpretation for each test case. NCCLS (now CLSI) standards are developed by experts, but the direct involvement of individual experts for this specific study's ground truth establishment is not detailed.

4. Adjudication Method

The adjudication method is not explicitly described. The comparison is made against an "NCCLS frozen Reference Panel" and "Expected Results," which serves as the gold standard. This suggests a direct comparison rather than a human-expert adjudication process for discrepancies.

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

No Multi-Reader Multi-Case (MRMC) comparative effectiveness study is mentioned. This submission focuses on the performance of the automated system compared to a reference standard, not on how human readers' performance improves with or without the system's assistance.

6. Standalone Performance Study

Yes, a standalone performance study was conducted. The "external evaluation" directly compares the performance of the MicroScan® Dried Gram-Positive MIC/Combo Panels with Ertapenem (the algorithm/device) against an NCCLS frozen Reference Panel. The reported Essential Agreement of >96% reflects the standalone performance of the device.

7. Type of Ground Truth Used

The ground truth used was primarily a reference standard. Specifically, the device's performance was compared to:

An NCCLS frozen Reference Panel. NCCLS (National Committee for Clinical Laboratory Standards, now Clinical and Laboratory Standards Institute - CLSI) panels are widely accepted reference standards for antimicrobial susceptibility testing.
Expected Results for stock Challenge strains. These expected results would have been established through validated methods and likely represent a consensus or definitive determination of susceptibility.

8. Sample Size for the Training Set

The document does not provide any information regarding the sample size used for the training set. This is common for submissions of this nature, as the focus is on the validation of the final product with a distinct test set.

9. How Ground Truth for the Training Set Was Established

The document does not provide details on how the ground truth for any potential training set was established. Given the nature of the device (a diagnostic test for antimicrobial susceptibility), if machine learning was involved in its development, the training ground truth would similarly likely rely on established reference methods like NCCLS/CLSI standards or other validated laboratory techniques. However, the text does not elaborate on this aspect.

Summary

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K0435589

510(k) Summary

FEB 1 4 2005

510(k) Submission Information:

Device Manufacturer:	Dade Behring, Inc.
Contact name:	Cynthia Van Duker, Regulatory Affairs Manager
Fax:	916-374-3144
Date prepared:	December 20, 2004
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 - Ertapenem
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 Ertapenem.

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 Ertapenem when compared with the frozen Reference panel.

Inoculum and instrument reproducibility testing demonstrated acceptable reproducibility and precision with Ertapenem, regardless of which inoculum method (i.e., Turbidity and Prompt), or instrument (autoSCAN-48 and WalkAway®) was used.

Quality Control testing demonstrated acceptable results for Ertapenem.

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Image /page/1/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, consisting of 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.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

FEB 1 4 2005

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

Re: K043589

Trade/Device Name: MicroScan® Dried Gram-Positive MIC/Combo Panels with Ertapenem (0.002 - 32 mcg/ml) Regulation Number: 21 CFR 866.1640 Regulation Name: Antimicrobial susceptibility test powder Regulatory Class: Class II Product Code: JWY; LTT; LTW Dated: December 22, 2004 Received: December 28, 2004

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 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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Page 2 -

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)276-0484. 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,

Sale, a For

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):_____________________________________________________________________________________________________________________________________________________

Device Name: MicroScan® Dried Gram-Positive MIC/Combo Panels with Ertapenem (0.002 - 32 mcg/ml)

Indications For Use:

This particular submission is for the addition of the antimicrobial Ertapenem at concentrations of 0.002 to 32 mcg/ml to the test panel.

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

Staphylococcus aureus (methicillin-susceptible strains) Streptococcus agalactiae

Prescription Use J (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)

Ludde Poole

Division Sign-Off

Page 1 of 1

Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) KD43589.

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).