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 - 24 hours at 35°C +/- 1°C in a non-CO2 incubator, and read either visually or with MicroScan instrumentation, according to the Package Insert.

The MicroScan Inducible Clindamycin test is intended to detect inducible clindamycin resistance in staphylococci in a broth microdilution system. The ICd test applies to isolates that are erythromycin resistant or intermediate and clindamycin susceptible or intermediate.

This particular submission is for the addition of the Inducible Clindamycin test, consisting of 4 mcg/ml of erythromycin and 0.5 mcg/ml of clindamycin, to the test panel.

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 antiryicrobial concentration showing inhibition of growth.

AI/ML Overview

Here's a breakdown of the acceptance criteria and the study details for the MicroScan Dried Gram-Positive MIC/Combo Panels with the Inducible Clindamycin test, based on the provided text:

Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Acceptance Criteria (Implicit)	Reported Device Performance (%)
Categorical Agreement	Substantially equivalent performance compared with CLSI D-zone disk diffusion test (quantitative threshold not explicitly stated but implied by performance)	98.7%
Sensitivity	Acceptable. (Quantitative threshold not explicitly stated but implied by performance)	98.1%
Specificity	Acceptable. (Quantitative threshold not explicitly stated but implied by performance)	100.0%
Reproducibility	Acceptable reproducibility and precision "regardless of which inoculum method (i.e., Turbidity and Prompt™), or instrument (autoSCAN-4® and WalkAway®) was used"	Acceptable
Quality Control	Acceptable results for the MicroScan Inducible Clindamycin test	Acceptable

Study Details

Sample sizes used for the test set and the data provenance:
- Test Set Sample Size: Not explicitly stated as a number. The study mentions "fresh and stock Efficacy isolates and stock Challenge strains."
- Data Provenance: Not explicitly stated (e.g., country of origin). The study was an "external design validation (Clinical Trial)". It's a prospective evaluation for efficacy isolates and stock challenge strains.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This information is not provided in the document. The ground truth method, CLSI D-zone disk diffusion test, is a standardized laboratory test, not an expert consensus for each case.
Adjudication method for the test set:
- This information is not provided. Given that the comparative method is the CLSI D-zone disk diffusion test, it's unlikely that a human adjudication method in the typical sense (like 2+1, 3+1 for imaging) was used. The CLSI D-zone disk diffusion test itself serves as the reference standard.
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:
- No, an MRMC comparative effectiveness study was not done. This device is an in-vitro diagnostic (IVD) test for antimicrobial susceptibility, not an imaging AI device that assists human readers.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Yes, the study assesses the "standalone" performance of the MicroScan Inducible Clindamycin test against the CLSI D-zone disk diffusion test. While the test involves laboratory procedures performed by humans, the performance metrics (Categorical Agreement, Sensitivity, Specificity) are for the device's output itself, not its assistance to a human interpreter. The text mentions it can be "read either visually or with MicroScan instrumentation."
The type of ground truth used:
- The ground truth used was the CLSI D-zone disk diffusion test. This is a recognized standard laboratory method for detecting inducible clindamycin resistance. For challenge strains, "Expected Results determined prior to the evaluation" also served as ground truth.
The sample size for the training set:
- This information is not provided. The document describes a validation study, not the development process. Given this is an IVD microbiology test, there might not be a "training set" in the machine learning sense, but rather development and internal validation data that isn't detailed in this summary.
How the ground truth for the training set was established:
- Since the training set sample size is not provided, the method for establishing its ground truth is also not provided.

Summary

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K081182

510(k) Summary

AUG - 8 2008

510(k) Submission Information:

Device Manufacturer: Siemens Healthcare Diagnostics

Contact name:	Libby Warriner, Regulatory Affairs Senior Compliance Specialist
Fax:	916-374-3144
Date prepared:	April 23, 2008
Product Name:	Microdilution Minimum Inhibitory Concentration (MIC) Panels
Trade Name:	MicroScan Dried Gram-Positive MIC/Combo Panels
Intended Use:	Detection of inducible clindamycin resistance in staphylococci
510(k) Notification:	New antimicrobial test – Inducible Clindamycin
Predicate device:	MicroScan Dried Gram-Positive MIC/Combo Panels

510(k) Summary:

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 antiry icrobial concentration showing inhibition of growth.

The proposed MicroScan Dried Gram-Positive MIC/Combo Panel with the Inducible Clindamycin test demonstrated substantially equivalent performance when compared with the CLSI D-zone disk diffusion test, as defined in the FDA document "Class InSucci a Controls Guidance Document: Antimicrobial Susceptibility Test (AST) Systems; Pouidance for Industry and FDA", dated March 5, 2007, and "Guidance for Industry and FDA Staff— Statistical Guidance on Reporting Results from Studies Evaluating Diagnostic Tests", dated March 13, 2007. The Premarket Notification (510[k]) presents data in support of the MicroScan Dried Gram-Positive MIC/Combo Panel with the Inducible Clindamycin test.

The external design validation (Clinical Trial) 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 parts romance with results of the CLSI D-zone disk diffusion test. Challenge strains were compared to Expected Results determined prior to the evaluation.

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The MicroScan Inducible Clindamycin test demonstrated acceptable performance with an overall Categorical Agreement of 98.7% when compared with the CLSI D-zone disk diffusion test. Overall sensitivity was 98.1% and specificity was 100.0%.

Inoculum and instrument reproducibility testing demonstrated acceptable reproducibility and precision with Inducible Clindamycin, 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 the MicroScan Inducible Clindamycin test.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo features a stylized eagle with three lines representing its wings and body. The eagle is positioned inside a circle, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" encircling it.

Food and Druq Administration 2098 Gaither Road Rockville MD 20850

Ms. Libby Warriner Regulatory Affairs Compliance Specialist Siemens Healthcare Diagnostics 1584 Enterprise Blvd West Sacramento, CA 95691

AUG - 8 2008

Re: K081182

Trade/Device Name: MicroScan® Dried Gram Positive MIC/Combo Panels with the Inducible Clindamycin test

Regulation Number: 21 CFR 866.1640 Regulation Name: Antimicrobial Susceptibility Test Powder Regulatory Class: Class II Product Code: JWY, LRG, LTT, LTW Dated: July 23, 2008 Received: July 25, 2008

Dear Ms. Warriner:

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 predicated devices 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 advice for your device on our labeling regulation (21 CFR Part 801), 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). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely vours.

Sally attaym

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): K081187

Device Name: MicroScan Dried Gram-Positive MIC/Combo Panels with the Inducible Clindamycin Test

Indications For Use:

This particular submission is for the addition of the Inducible Clindamycin test, consisting of 4 mcg/ml of erythromycin and 0.5 mcg/ml of clindamycin, to the test panel.

The gram-positive organisms which may be used for the Inducible Clindamycin test in this panel are:

Staphylococcus spp

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

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

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Evaluation and Safety

510(k) K081182

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).