The MicroScan® Dried Gram-Negative 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-negative bacilli. 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 Tigecycline at concentrations of 0.015 to 32 mcg/ml to the test panel.

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

Citrobacter freundii Enterobacter cloacae Escherichia coli Klebsiella oxytoca Klebsiella pneumoniae

Device Description

MicroScan Dried Gram-Negative 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 acrobic and facultative anaerobic gram-negative bacilli.

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, outlining the acceptance criteria and study details for the MicroScan Dried Gram-Negative MIC/Combo Panels with Tigecycline:

Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Criteria	Reported Device Performance
Overall Agreement	Essential Agreement	99.0% for Tigecycline
Reproducibility	Acceptable Inoculum Reproducibility (Turbidity)	Demonstrated acceptable reproducibility (Tigecycline)
Reproducibility	Acceptable Inoculum Reproducibility (Prompt™)	Demonstrated acceptable reproducibility (Tigecycline)
Reproducibility	Acceptable Instrument Reproducibility (autoSCAN-40)	Demonstrated acceptable reproducibility (Tigecycline)
Reproducibility	Acceptable Instrument Reproducibility (WalkAway®)	Demonstrated acceptable reproducibility (Tigecycline)
Quality Control	Acceptable QC results	Demonstrated acceptable results (Tigecycline)

Study Details

Sample Size Used for the Test Set and Data Provenance:
- Sample Size: Not explicitly stated as a number of isolates or tests. The external evaluation was conducted with "fresh and stock Efficacy isolates and stock Challenge strains."
- Data Provenance: Not specified, but the use of "external evaluation" suggests data was collected from sites outside the manufacturer's internal testing facilities. The country of origin is not mentioned. The data is retrospective, as "stock Efficacy isolates and stock Challenge strains" were used.
Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
- Number of Experts: Not specified.
- Qualifications of Experts: Not specified.
Adjudication Method for the Test Set:
- Adjudication Method: Not explicitly stated. For the "Challenge strains," their performance was "compared to Expected Results determined prior to the evaluation," suggesting a pre-defined set of known results rather than a real-time adjudication process by experts. For "Efficacy isolates," the comparison was against a CLSI frozen Reference Panel, again indicating a reference standard rather than expert consensus adjudication of each case.
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 study was not done. This device is an automated antimicrobial susceptibility test (AST) panel, not an AI-assisted diagnostic device that would involve human readers interpreting images or data with and without AI assistance. The performance is compared to a reference standard (CLSI frozen panel), not human interpretation.
If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Yes, a standalone study was done. The device's performance (MicroScan Dried Gram-Negative MIC/Combo Panel) was evaluated solely based on its ability to determine MICs compared to a "CLSI frozen Reference Panel." The stated "99.0% Essential Agreement" is a direct measure of the device's accuracy against this objective reference standard. Human intervention described is limited to inoculation and reading (visually or with MicroScan instrumentation), but the performance evaluation is of the test system itself against a known reference.
The Type of Ground Truth Used:
- Reference Standard (CLSI frozen Reference Panel) and Expected Results: The primary ground truth for efficacy isolates was the "CLSI frozen Reference Panel." For challenge strains, "Expected Results determined prior to the evaluation" served as the ground truth. This indicates a highly standardized and objective reference method for determining antimicrobial susceptibility.
The Sample Size for the Training Set:
- Not Applicable. This submission describes the validation of an antimicrobial susceptibility test (AST) panel following a traditional broth dilution method, not an AI/ML-based algorithm that typically requires a discrete "training set." The panel is a diagnostic test kit, and its "training" is inherent in its design and manufacturing process, optimized through extensive research and development for antimicrobial properties and concentrations, not through machine learning on a dataset.
How the Ground Truth for the Training Set Was Established:
- Not Applicable. As noted above, there isn't a "training set" in the context of an AI/ML algorithm. The design and validation of the MIC panels rely on established microbiology principles, standardized broth dilution methods (CLSI guidelines), and quality control procedures, rather than a machine learning training process with a ground truth dataset.

Summary

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K083262

FEB 1 8 2009

510(k) Summary

510(k) Submission Information:

Device Manufacturer:	Siemens Healthcare Diagnostics
Contact name:	Libby Warriner, Regulatory Affairs Senior Compliance Specialist
Fax:	916-374-3144
Date prepared:	November 3, 2008
Product Name:	Microdilution Minimum Inhibitory Concentration (MIC) Panels
Trade Name:	MicroScan Dried Gram-Negative MIC/Combo Panels
Intended Use:	To determine antimicrobial agent susceptibility
510(k) Notification:	New antimicrobial - Tigecycline
Predicate device:	MicroScan Dried Gram-Negative MIC/Combo Panels

510(k) Summary:

The proposed MicroScan Dried Gram-Negative 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 March 5, 2007. The Premarket Notification (510[k]) presents data in support of the MicroScan Dried Gram-Negative MIC/Combo Panel with Tigecycline.

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-Negative Panel by comparing its performance with an CLSI frozen Reference panel. Challenge strains were compared to Expected Results determined prior to the evaluation. The Dried Gram-Negative Panel demonstrated acceptable performance with an overall Essential Agreement of 99.0% for Tigecycline when compared with the frozen Reference panel.

Inoculum and instrument reproducibility testing demonstrated acceptable reproducibility and precision with Tigecycline, regardless of which inoculum method (i.e., Turbidity and Prompt™), or instrument (autoSCAN-40 and WalkAway®) was used.

Quality Control testing demonstrated acceptable results for Tigecycline.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

FEB 1 8 2009

Ms. Libby Warriner Regulatory Affairs Compliance Specialist Siemens Healthcare Diagnostics 2040 Enterprise Blvd West Sacramento, CA 95691

Re: K083262

Trade/Device Name: MicroScan® Dried Gram - Negative MIC/Combo Panels with Tigecvcline (0.15 - 32mcg/ml)

Regulation Number: 21 CER 866.1640 Regulation Name: Antimicrobial Susceptibility Test Regulatory Class: Class II Product Code: LTT, LRG,JWY,LTW Dated: November 3, 2008 Received: November 5, 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 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 (sestaboye) into elther class II (Specials 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 (OS) 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 yours,

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): k 083262

Device Name: MicroScan® Dried Gram-Negative MIC/Combo Panels with Tigecycline (0.015 -32 mcg/ml)

Indications For Use:

This particular submission is for the addition of the antimicrobial Tigecycline at concentrations of 0.015 to 32 mcg/ml to the test panel.

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

Citrobacter freundii Enterobacter cloacae Escherichia coli Klebsiella oxytoca Klebsiella pneumoniae

Prescription Use V. (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)

Freddie W. Rade
Division Sign-Off

Office of In Vitro Diagnostic Device Evaluation and Safety

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510(k) K08 32 62

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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).