The MicroScan® MICroSTREP plus® Panel is used to determine quantitative and/or qualitative antimicrobial agent susceptibility of colonies grown on solid media of aerobic streptococci including Streptococcus pneumoniae. After inoculation, panels are incubated for 20 -24 hours at 35°C +/- 1°C in a non-CO2 incubator, and read visually. Alternatively, the panels can be incubated in and read by the MicroScan® WalkAway System, according to the Package insert.

This particular submission is for the addition of the antimicrobial agent Linezolid, at concentrations of 0.12 to 16 ug/mL, to the test panel.

The organisms which may be used for Linezolid susceptibility testing in this panel are:

Streptococcus pneumoniae including multi-drug resistant strains

Streptococcus pyogenes

Streptococcus agalactiae

Viridans group streptococci

Device Description

MicroScan MICroSTREP plus panels are designed for use in determining quantitative and/or qualitative antimicrobial agent susceptibility of colonies grown on solid media of . aerobic streptococci, including Streptococcus pneumoniae.

The antimicrobial susceptibility tests are miniaturizations of the broth dilution susceptibility test that have been diluted in water and dehydrated. Various antimicrobial agents are diluted in water, buffer or minute concentrations of broth to concentrations bridging the range of clinical interest. Panels are rehydrated with 115 µl Mueller-Hinton broth supplemented with 2-5% lysed horse blood (LHB), after inoculation of the broth with a standardized suspension of the organism. After incubation in a non-CO2 incubator for 20-24 hours, the minimum inhibitory concentration (MIC) for the test organism is manually read by observing the lowest antimicrobial concentration showing inhibition of growth. Alternatively, the panel can be incubated in and read by the MicroScan® WalkAway System.

AI/ML Overview

Here's an analysis of the acceptance criteria and study detailed in the provided documents, structured according to your request:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance (Linezolid)
Overall Essential Agreement with CLSI frozen Reference Panel	97.2%
Reproducibility	Acceptable reproducibility and precision
Quality Control	Acceptable results

2. Sample Size Used for the Test Set and Data Provenance

The document mentions "fresh and stock Efficacy isolates and stock Challenge strains" for the external evaluation. However, it does not explicitly state the specific number of isolates or strains used for either the efficacy or challenge testing.

Data Provenance: The study was an "external evaluation," implying it was conducted outside of the manufacturer's immediate control but within a regulated framework, comparing the device to a CLSI frozen Reference panel. The document does not specify the country of origin but implies a standard reference method commonly used in the US (CLSI). It is a retrospective evaluation as it uses established isolates.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications

The document states that "Challenge strains were compared to Expected Results determined prior to the evaluation." This implies that the "Expected Results" serve as the ground truth for the challenge strains.
The number of experts and their specific qualifications are not mentioned in the provided text. The ground truth for the reference panel itself is implicitly a consensus from standard methodologies (CLSI).

4. Adjudication Method for the Test Set

The document implies a direct comparison of the MicroScan MICroSTREP plus Panel's performance against a CLSI frozen Reference panel.
For challenge strains, performance was compared to "Expected Results."
No specific multi-reader adjudication method (e.g., 2+1, 3+1) is described for the test set. The comparison is against established reference values.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study involving human readers is not described in these documents. The study focuses on the performance of the automated/semi-automated AST system against a reference method. The document mentions reproducibility testing with different read methods (manual and WalkAway™ instrument), but this refers to the device's consistency, not the improvement of human readers with AI assistance.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

Yes, a standalone performance study was done. The device itself (MicroScan MICroSTREP plus Panels) is assessed for its ability to determine antimicrobial susceptibility. The "manual" read method mentioned in reproducibility testing still refers to reading the panel results, not a human interpretation divorced from the device's output. The "WalkAway™ instrument" automatically reads the panel, which is a standalone function of the device system.

7. The Type of Ground Truth Used

The primary ground truth used is a CLSI frozen Reference Panel. For challenge strains, "Expected Results" determined prior to the evaluation were used, which would also be based on established reference methods. This falls under expert consensus derived from standardized laboratory procedures.

8. The Sample Size for the Training Set

The document does not provide information on the sample size used for the training set. The focus is on the performance evaluation of the device as submitted. This type of device (AST panel) typically relies on biochemical principles and established MIC ranges, rather than deep learning models that require distinct training sets in the same way an AI image analysis algorithm would.

9. How the Ground Truth for the Training Set Was Established

Given that the document does not mention a distinct "training set" in the context of machine learning, the question of how its ground truth was established is not applicable. The device's development would be based on established microbiological principles for determining MICs, where the "ground truth" is defined by standard reference methods like those outlined by CLSI.

Summary

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February 26, 2021

Image /page/0/Picture/1 description: The image shows the logos of the Department of Health & Human Services and the U.S. Food & Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.

Siemens Healthcare Diagnostics, Inc. Jenifer Dawson Driscoll Regulatory Technical Specialist % Elisabeth Warriner Senior Analyst, Regulatory Affairs 1584 Enterprise Blvd. West Sacramento, California 95691

Re: K111677

Trade/Device Name: Microscan(r) Microstrep Plus(r) Regulation Number: 21 CFR 866.1640 Regulation Name: Antimicrobial susceptibility test powder Regulatory Class: Class II Product Code: LRG, JWY, LTW, JTZ

Dear Elisabeth Warriner:

The Food and Drug Administration (FDA) is sending this letter to notify you of an administrative change related to your previous substantial equivalence (SE) determination letter dated August 4, 2011. Specifically, FDA is updating this SE Letter because FDA has added a new product code (JTZ) to better categorize your device technology.

Please note that the 510(k) submission was not re-reviewed. For questions regarding this letter please contact Ribhi Shawar, Ph.D., OHT7: Office of In Vitro Diagnostics and Radiological Health, (301-796-6698), ribhi.shawar@fda.hhs.gov.

Sincerely,

Ribhi Shawar -S

Ribhi Shawar, Ph.D. (ABMM) Chief General Bacteriology and Antimicrobial Susceptibility Branch Division of Microbiology Devices OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Ouality Center for Devices and Radiological Health

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/1/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of an eagle.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993

Siemens Healthcare Diagnostics, Inc. c/o Ms. Jenifer Dawson Driscoll Regulatory Technical Specialist 1584 Enterprise Blvd. West Sacramento, CA 95691

2011 AUG

Re: K111677

Trade/Device Name: MicroScan®MICroSTREP plus Panels with Linezolid (0.12- 16 ug/mL) 21CFR 8866.1640 Regulation Number: Antimicrobial Susceptibility Test Powder Regulation Name: Regulatory Class: Class II Product Code: LRG, JWY, LTW Dated: May 31, 2011 Received: June 15, 2011

Dear Ms. Driscoll:

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 class II (Special Controls), it may be subject to such 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 CFR Part 807); labeling (21 CFR Parts 801 and 809); medical device reporting (reporting of

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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. 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 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety 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/ReportalProblem/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/industry/support/index.html.

Sincerely vours,

Hall athina

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 | | 67

Device Name: MicroScan® MICroSTREP plus® with Linezolid (0.12 – 16 ug/ml)

Indications For Use:

This particular submission is for the addition of the antimicrobial agent Linezolid, at concentrations of 0.12 to 16 ug/mL, to the test panel.

The organisms which may be used for Linezolid susceptibility testing in this panel are:

Streptococcus pneumoniae including multi-drug resistant strains

Streptococcus pyogenes

Streptococcus agalactiae

Viridans group streptococci

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)

Reddit Coole

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

510(k) K111677

Page 1 of _1

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K 111677

AUG - 4 2011

510(k) Summary

510(k) Submission Information:

Device Manufacturer:	Siemens Healthcare Diagnostics
Contact name:	Jenifer Driscoll, Regulatory Technical Specialist
Fax:	916-374-2545
Date prepared:	May 26, 2011
Product Name:	Microdilution Minimum Inhibitory Concentration (MIC) Panels
Trade Name:	MicroScan® MICroSTREP plus® Panels
Intended Use:	To determine antimicrobial agent susceptibility
510(k) Notification:	New antimicrobial - Linezolid
Predicate device:	MicroScan MICroSTREP plus Panels - Levofloxacin (K020556)

510(k) Summary:

The proposed MicroScan MICroSTREP plus 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 MICroSTREP plus Panel with Linezolid.

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 MICroSTREP plus Panel by comparing its performance with a CLSI frozen Reference panel. Challenge strains were compared to Expected Results determined prior to the evaluation. The MICroSTREP plus Panel demonstrated acceptable performance with an overall Essential Agreement of 97.2% for Linezolid when compared with the frozen Reference panel.

Reproducibility testing demonstrated acceptable reproducibility and precision with Linezolid, regardless of which read method (manual and WalkAway" instrument) was used with the turbidity inoculation method.

Quality Control testing demonstrated acceptable results for Linezolid.

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TPLC Detailed View

Image /page/5/Picture/2 description: The image shows a diagram of a centrifugal pump. The diagram shows a circular impeller with several curved blades. Arrows indicate the direction of fluid flow into the center of the impeller and then outward along the blades. The text labels in the image identify the different parts of the pump.

Product Code Manufacturer Class Regulation Device Classification Device Name Date Last Listed

Not Listed

CDRH Gen Docs without Manufacturer (None)

Premarket Reviews Completed (None)

Under Review, Withdrawn or Closed without Product Code (None)

Standards and Guidance (None)

MDR Summary (None)

MDR Analyst (None)

MDR Distribution by Brand - Death or Injury (None)

Patient Problems (None)

Patient Outcomes (None)

Device Problems (None)

Manufacturer Evaluation Results (None)

Manufacturer Evaluation Conclusions (None)

Recalls (None)

Inspections (None)

CDRH Gen Docs without Manufacturer (None)

Rad Health Reports (None)

Rad Health Correspondence (None)

Rad Health Adverse Events (None)

Rad Health EIRs (None)

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).