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 bacteria. 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 particular submission is for the addition of the antimicrobial Ceftaroline at concentrations of 0.06 to 16 mcg/ml to the test panel.

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

Staphylococcus aureus

methicillin-susceptible and methicillin-resistant isolates - skin isolates only ●

methicillin-susceptible isolates community-acquired bacterial pneumonia isolates -

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 bacteria.

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 a breakdown of the acceptance criteria and study information for the MicroScan® Dried Gram-Positive MIC/Combo Panels with Ceftaroline, based on the provided text:

Acceptance Criteria and Device Performance

Acceptance Criteria Category	Specific Criteria	Reported Device Performance	Study that Proves Device Meets Criteria
Overall Performance	Essential Agreement	99.0% for Ceftaroline	External evaluation comparing panels with CLSI frozen Reference Panel.
Reproducibility	Acceptable reproducibility and precision	Demonstrated acceptable for Ceftaroline	Inoculum and instrument reproducibility testing.
Quality Control	Acceptable results	Demonstrated acceptable for Ceftaroline	Quality Control testing.

Study Details

Information Point	Description Based on Provided Text
1. Sample size for test set	Not explicitly stated as a number. The external evaluation used "fresh and stock Efficacy isolates and stock Challenge strains." S. aureus clinical isolates were also evaluated.
2. Data provenance (country of origin, retrospective/prospective)	Not specified. The study is described as an "external evaluation." It is implied to be prospective for the purpose of validating the device.
3. Number of experts used to establish ground truth & qualifications	Not specified. The reference standard used was a "CLSI frozen Reference Panel" and "Expected Results determined prior to the evaluation" for challenge strains. No mention of human experts establishing ground truth for the test set.
4. Adjudication method	Not applicable, as the ground truth for the test set was established using a CLSI frozen Reference Panel or predetermined "Expected Results" for challenge strains, not expert consensus requiring adjudication.
5. MRMC comparative effectiveness study	No. This study is validating an antimicrobial susceptibility test system, not an AI-assisted diagnostic tool that would typically involve human readers.
6. Standalone (algorithm only without human-in-the-loop) performance	Yes, the device itself is a standalone system for determining MIC. While some reading methods are manual, the performance metrics (Essential Agreement) are for the panel's accuracy against a reference, which is an inherent algorithmic function of the panel's design. The text mentions "read manually" for S. aureus isolates, but also "MicroScan instrumentation" for other readings, indicating both possibilities for interaction with the device outputs.
7. Type of ground truth used	- CLSI frozen Reference Panel: For the external evaluation comparing the MicroScan panels. - Expected Results: For challenge strains.
8. Sample size for training set	Not applicable. This device is a diagnostic panel with pre-determined concentrations, not a machine learning algorithm that requires a training set in the conventional sense. The "training" would be the initial development and optimization of the panel's chemistry and design, which is not detailed here.
9. How ground truth for training set was established	Not applicable in the context of machine learning. The "ground truth" for the development of the panel would be based on established microbiology principles and CLSI guidelines for antimicrobial susceptibility testing, which dictate the acceptable range of concentrations and expected results for known organisms.

Summary

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K123933

MAR 1 4 2013

SIEMENS

510(k) Summary

510(k) Submission Information:

Device Manufacturer:	Siemens Healthcare Diagnostics
Contact name:	Elisabeth Warriner, Regulatory Technical Specialist
Phone:	916-374-3244
Fax:	916-372-6418
Date prepared:	March 12, 2013
Product Name:	Microdilution Minimum Inhibitory Concentration (MIC) Panels
Trade Name:	MicroScan® Dried Gram-Positive MIC/Combo Panels with Ceftaroline (0.06-16mcg/ml)
Intended Use:	To determine antimicrobial agent susceptibility
Classification:	Class II
Product Code:	LTT
510(k) Notification:	New antimicrobial - Ceftaroline
Predicate device:	MicroScan Dried Gram-Positive MIC/Combo Panels - Linezolid (K003619)

510(k) Summary:

The proposed MicroScan Dried Gram-Positive MIC/Combo Panel demonstrated substantially equivalent performance when compared with an CLSI 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 August 28, 2009. The Premarket Notification (510[k]) presents data in support of the MicroScan Dried Gram-Positive MIC/Combo Panel with Ceftaroline.

The external evaluation was conducted with fresh and stock Efficacy isolates and stock Challenge strains. S. aureus clinical isolates were evaluated using only the turbidity inoculation method and read manually. Challenge and Reproducibility isolates were tested using all inoculation and reading methods. The external evaluations were designed to confirm the acceptability of the proposed Dried Gram-Positive Panel by comparing its performance with a CLSI 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 99.0% for Ceftaroline when compared with the frozen Reference panel.

Inoculum and instrument reproducibility testing demonstrated acceptable reproducibility and precision with Ceftaroline, 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 Ceftaroline.

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Image /page/1/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is a stylized symbol resembling an abstract caduceus, with three curved lines representing a staff and a serpentine form at the bottom.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002

March 14, 2013

Siemens Healthcare Diagnostics C/O Elisabeth Warriner Regulatory Technical Specialist 2040 Enterprise Blvd. West Sacramento, CA 95691

Re: K123933

Trade/Device Name: MicroScan Dried Gram-Positive MIC/Combo Panels with Ceftaroline (0.06 - 16 mdg/ml) Regulation Number: 21 CFR 866.1640 Regulation Name: Antimicrobial Susceptibility Test Powder Regulatory Class: Class II Product Code: LTT, JWY, LRG, LTW Dated: December 17, 2012 Received: December 20, 2012

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 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 additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. 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

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Page 2 - Ms. Warriner

CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Parts 801 and 809), please contact the Office of In Vitro Diagnostics and Radiological Health at (301) 796-5450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industrv/support/index.html.

Sincerely yours,

Uwe Schierf -S for

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

Enclosure

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Indications for Use

K123933 510(k) Number (if known):

Device Name: MicroScan® Dried Gram-Positive MIC/Combo Panels with Ceftaroline (0.06 - 16 mcg/ml)

Indications For Use:

This particular submission is for the addition of the antimicrobial Ceftaroline at concentrations of 0.06 to 16 mcg/ml to the test panel.

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

Staphylococcus aureus

methicillin-susceptible and methicillin-resistant isolates - skin isolates only ●

methicillin-susceptible isolates community-acquired bacterial pneumonia isolates -
V Prescription Use · (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 807 Subpart C)

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

AND/OR

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

Uwe Scherf 2013.03.14 16:37:20=0

Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety

K123933 510(k)

Page 1 of 1

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).