MRSA/SA ELITe MGB® is a qualitative in vitro diagnostic test for the direct detection of Staphylococcus aureus (SA) and methicillin-resistant Staphylococcus aureus (MRSA) using DNA purified from nasal swabs. MRSA/SA ELITe MGB® is intended to aid in the prevention and control of MRSA infections in healthcare settings. It is not intended to diagnose, guide or monitor MRSA infections, or provide results of susceptibility to oxacillin/methicilliin. A negative result does not preclude MRSA/SA (Staphylococcus aureus) nasal colonization. Concomitant cultures are necessary to recover organisms for epidemiological typing or for further susceptibility testing.

Special conditions for use statement(s): Prescription Use Only.

Device Description

MRSA/SA ELITe MGB® is a real-time, multiplex polymerase chain reaction (PCR) assay for the in vitro qualitative detection of MRSA and SA DNA extracted from human nasal swab samples. In this system, sample preparation and amplification/real-time detection are completed on separate instruments. Sample processing is completed on the bioMérieux NucliSENS® easyMAG® instrument with bioMérieux NucliSENS Nucleic Acid Extraction Reagents according to the manufacturer's instructions. Following processing, the extracted sample is placed in the well of a 96 well plate to which "monoreagent" is added. The monoreagent contains the primers and probes for the genes of interest and the internal control combined with master mix. The assay is performed on an Applied Biosystems 7500 FAST Dx System that consists of the 7500 FAST Dx instrument, a personal computer, 96-well plates and seals. The total system run time is 150 minutes consisting of 60 minutes for sample processing and about 90 minutes for the real time amplification and detection steps. The instrument never comes into contact with any fluids within the 96-well plate. Each disposable plate is intended to test up to 96 samples, controls or any mixture thereof. The 96-well plates are not re-usable and are specific to the system. The kit contains enough reagents for 100 reactions. One positive and one negative control are required for each PCR run; a Negative Processing Control and a Positive Processing Control are recommended to be run in each extraction run. The design of the assay includes systems to identify both the gene responsible for methicillin resistance and for a conserved portion of a gene unique to S. aureus. Thus, for a true "MRSA," both targets will be identified in roughly equal proportions. Results are determined by using an algorithm that compares output. Cq, from the cycler (called Ct in the output from the cvcler.) The algorithm is implemented for automatic results determination by analyzing the output Cq with ELITe MGB® software.

AI/ML Overview

The provided text describes the acceptance criteria and the study that proves the performance of the MRSA/SA ELITe MGB® Software, which is a software component of the overall MRSA/SA ELITe MGB® test system. It's important to note that this 510(k) submission (K132468) is specifically for the software that automates the calling algorithm, not the entire diagnostic test kit, which was previously cleared under K112937. Therefore, most performance studies (analytical sensitivity, reactivity, detection limit, reproducibility, carry-over/cross-contamination, clinical studies) are referenced back to the original K112937 submission as they are not affected by the software change.

Here's a breakdown of the requested information based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

For this specific 510(k) (K132468), the primary acceptance criterion is the concordance of results generated by the new automated software with the results generated by the previously cleared manual calling algorithm.

Acceptance Criteria	Reported Device Performance (MRSA/SA ELITe MGB® Software)
100% concordance with results of MRSA/SA ELITe MGB® using the manual calling algorithm found in the labeling for MRSA/SA ELITe MGB®.	100% concordance with results of MRSA/SA ELITe MGB® using the manual calling algorithm.

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

The document states, "In accordance with guidance received from FDA in Q120176, the original data from K112937 was recalculated using ELITe MGB software."

Sample Size for Test Set: The specific sample size used for the recalculation is not explicitly stated in this document but is referred to as "the original data from K112937." To determine the exact sample size, one would need to review the K112937 submission.
Data Provenance: The data is "original data from K112937," implying it was generated during the studies for the initial clearance of the MRSA/SA ELITe MGB® assay. The document doesn't specify the country of origin of the data or whether it was retrospective or prospective, though diagnostic assay validation studies typically involve prospective collection of samples or a combination of prospective and banked (retrospective) samples.

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

This specific submission (K132468) is evaluating the concordance of software interpretation with a manual interpretation algorithm from K112937, rather than establishing a new ground truth against a clinical "gold standard." Therefore, the concept of "experts establishing ground truth" in the traditional sense doesn't directly apply here. The manual calling algorithm itself represents the established interpretation logic from the previous clearance.

4. Adjudication Method for the Test Set

Not applicable for this type of software validation study. The study involved a direct comparison of algorithmic output with the output of a previously defined manual algorithm. There was no "adjudication" between different human interpretations or human and AI interpretations in this specific study.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done for this software submission. The purpose of this submission was to validate the automated software's agreement with the manual algorithm, not to compare human performance with or without AI assistance.

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

Yes, this study is inherently a standalone performance evaluation of the algorithm. The software (algorithm) processes the raw data and determines results automatically. The evaluation compares these automated results directly against the results that would have been obtained by applying the manual algorithm from the predicate device's labeling to the same raw data. There is no human "in the loop" performing interpretation for this part of the study; the software automates the interpretation step.

7. The Type of Ground Truth Used

The "ground truth" for this software validation study is the results derived from the manual calling algorithm as described in the labeling of the predicate device (K112937). It's a comparison to an established interpretation method, not directly to pathology, outcomes data, or expert consensus in the typical sense.

8. The Sample Size for the Training Set

The document states, "The development of the software is in compliance with the requirements of the Guidance. The performance of the software has been validated." However, it does not explicitly mention a separate "training set" size for the ELITe MGB® software development. Software for diagnostic devices generally undergoes rigorous development and verification, which might involve internal testing with various data, but the specific size of such an internal training set is not provided here. The critical performance evaluation (concordance) was done on the original data from K112937.

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

Given that a specific "training set" size is not detailed for this software validation, the method for establishing its ground truth is also not elaborated. For the underlying MRSA/SA ELITe MGB® assay (K112937), the ground truth for clinical performance would have been established through methods like confirmatory microbiology cultures, potentially with additional molecular or phenotypic characterization for MRSA distinction, which are standard for such diagnostic tests. The software's "training" (development) would have been guided by the established rules of the manual calling algorithm.

Summary

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KJ32468

510(k) Summary

MRSA/SA ELITe MBG

Date: .

August 5, 2013

K112937

Epoch Biosciences MRSA/SA ELITe MGB®

Epoch Biosciences

21720 23td Dr SE, Suite 150 Bothell, WA 98021 USA

OCT 17 2013

Contact Person:

Submitter:

Debra K. Hutson Director, QA/RA, North America 21720 23rd Dr SE, Suite 150 Bothell, WA 98021 Phone: 425-482-5174 425-482-5550 Fax: Email: d.hutson@elitechgroup.com

1. Device Name: MRSA/SA ELITe MGB® Device Class: Class II Product Code: NQX Antimicrobial Susceptibility Test Powder Regulation name: Panel: 83 Microbiology Regulation Number: 21 CFR 866.1640

Predicate Device:
Intended Use MRSA/SA ELITe MGB® is a qualitative in vitro diagnostic test for the direct detection of Staphylococcus aureus (SA) and methicillin-resistant Staphylococcus aureus (MRSA) using DNA purified from nasal swabs. MRSA/SA ELITe MGB® is intended to aid in the prevention and control of MRSA infections in healthcare settings. It is not intended to diagnose, guide or monitor MRSA infections, or provide results of susceptibility to oxacillin/methicilliin. A negative result does not preclude MRSA/SA (Staphylococcus aureus) nasal colonization. Concomitant cultures are necessary to recover organisms for epidemiological typing or for further susceptibility testing.

Special conditions for use statement(s): Prescription Use Only.

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Device Description

Substantial Equivalence Information - Assay (reagent)

1. Predicate Device Name
- Epoch Bioscience MRSA/SA ELITe MGB®
1. K112937
1. Comparison with predicate

Similarities

Parameter	Test SystemEpoch Bioscience MRSA/SA ELITeMGB® using ELITe MGB® Software fordata analysis	Predicate DeviceEpoch Bioscience MRSA/SA ELITe MGB®K112937
Intended Use /Indication forUse	MRSA/SA ELITe MGB® is a qualitativein vitro diagnostic test for the directdetection of Staphylococcus aureus(SA) and methicillin-resistantStaphylococcus aureus (MRSA) usingDNA purified from nasal swabs.MRSA/SA ELITe MGB® is intended toaid in the prevention and control ofMRSA infections in healthcaresettings. It is not intended to diagnose,guide or monitor MRSA infections, orprovide results of susceptibility to	Same
Parameter	Test System	Predicate Device
	Epoch Bioscience MRSA/SA ELITE MGB® using ELITE MGB® Software for data analysis	Epoch Bioscience MRSA/SA ELITE MGB® K112937
	oxacillin/methicillin. A negative result does not preclude MRSA/SA ( Staphylococcus aureus ) nasal colonization. Concomitant cultures are necessary to recover organisms for epidemiological typing or for further susceptibility testing.
Mode of identification of S. aureus	Presence of conserved region in a Staphylococcus aureus -specific gene.	Same
Mode of detection for methicillin resistance	Presence of the mecA gene which is responsible for resistance to methicillin.	Same
Assay Format	Qualitative real-time polymerase chain reaction (PCR) assay using 3 forward primer, 3 reverse primers, and 3 fluorescent-labeled probes for the amplification and detection of Staphylococcus aureus (SA) and methicillin resistant Staphylococcus aureus (MRSA) DNA.	Same
Composition	MRSA/SA ELITE MGB® PCR MixTfi PCR Master Mix<0.01% MRSA/SA primers<0.01% Internal Control primers<0.01% MRSA/SA Fluorescent-labeled oligonucleotide probes<0.01% Internal Control Fluorescent-labeled oligonucleotide probe<0.01% Fluorescent Passive Reference dT(8)-AP593MRSA/SA Internal ControlTris buffer<0.01% EDTA0.01% total yeast RNA<0.001% Non-infectious plasmid DNA (recombinant) containing Internal Control sequencesMRSA/SA Positive ControlTris buffer<0.01% EDTA0.01% total yeast RNA<0.001% Non-infectious plasmid DNA (microbial) containing MRSA	Same
Parameter	Test SystemEpoch Bioscience MRSA/SA ELITe MGB® using ELITe MGB® Software fordata analysis	Predicate DeviceEpoch Bioscience MRSA/SA ELITe MGB®K112937
Specimen type	Direct from nasal swab	Same
Storage &Expiry	Stored in -20 °C freezer. The deviceis stable until the expiry date stated onthe label.	Same
Instrument	ABI 7500 Fast Dx	Same
Controls	Positive PCR control (Plasmid DNA(microbial) containing MRSAsequences)Internal Control (Plasmid DNA(recombinant) containing InternalControl sequences)	Same

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Differences

Parameter	Test SystemEpoch Bioscience MRSA/SA ELITeMGB® using ELITe MGB® Softwarefor data analysis	Predicate DeviceEpoch Bioscience MRSA/SA ELITeMGB® K112937
Resultsinterpretation	Automates the algorithm described inthe labeling such that raw data fromthe Applied Biosytems 7500 FASTDx instrument is calculated and thetest result determined and printed ona report.	Uses an algorithm described in thelabeling to determine test validity withrespect to controls and then todetermine the test result.

റ്റ. Standard/Guidance Document Reference

FDA Draft Guidance for Industry and Food and Drug Administration Staff Establishing . the Performance Characteristics of Nucleic Acid-Based In vitro Diagnostic Devices for the Detection and Differentiation of Methicillin-Resistant Staphylococcus aureus (MRSA) and Staphylococcus aureus (SA), Issued January 5, 2011.
. FDA Guidance for Industry, FDA Reviewers and Compliance on Off-the-Shelf Software Use in Medical Devices, Issued September 9, 1999.
. Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices, Document issued on: May 11, 2005.

10. Test Principle:

The test principle has not changed from that reviewed in K112937.

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Instrumentation/Software: 11.

a. Off the Shelf Software

The controls with respect to Off-the-Shelf software have not changed from those reviewed in K112937.

The system is performed with FDA-cleared devices, bioMérieux NucliSENS® easyMAG® extraction system and the Applied Biosystems® 7500 Fast Dx PCR Instrument. ELITechGroup Epoch Biosciences has a relationship with each on the manufacturers of these devices via service contracts such that Epoch will become aware, in the same time, as other users of the system, of changes to the device(s) or of the software used by the device(s). Internal quality assurance procedures are in place to verify the continued acceptable performance of the test device. Please, note, however, that the evaluation algorithm and the use of controls as indicated in the labeling, Internal Control and Positive Control, Negative Specimen Processing Control and Positive Specimen Processing Control, should identify for users any issues created by instrument or software changes.

b. Software to be used with this device

ELITech has developed a product, ELITe MGB® Software, fully in compliance with Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices, Document issued on: May 11, 2005. Information that substantiates this compliance are described. The software has a Moderate Level of Concern. The development of the software is in compliance with the requirements of the Guidance. The performance of the software has been validated.

Performance Characteristics - Analytical Performance 11.

a. Analytical Sensitivity

No further studies were performed since K112937. The change to automate the calling algorithm using ELITe MGB® software will not affect this performance.

b. Analytical Reactivity

No further studies were performed since K112937. The change to automate the calling algorithm using ELITe MGB® software will not affect this performance.

c. Detection limit

No further studies were performed since K112937. The change to automate the calling algorithm using ELITe MGB® software will not affect this performance.

d. Reproducibility

No further studies were performed since K112937. The change to automate the calling algorithm using ELITe MGB® software will not affect this performance.

e. Carry-Over / Cross-Contamination

No further studies were performed since K112937. The change to automate the calling algorithm using ELITe MGB® software will not affect this performance.

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Performance Characteristics -12.

a. Correlation with MRSA/SA ELITe MGB® manual calling algorithm

In accordance with guidance received from FDA in Q120176, the original data from K112937 was recalculated using ELITe MGB software.

Results of MRSA/SA ELITe MGB® using the ELITe MGB® Software exhibit 100% concordance with results of MRSA/SA ELITe MGB® using the manual calling algorithm found in the labeling for MRSA/SA ELITe MGB®.

b. Clinical Studies:

No further studies were performed since K112937. The change to automate the calling algorithm using ELITe MGB® software will not affect this performance.

c. Clinical Cut-off:

Not applicable

Conclusion 13.

The information on the principle and performance of the test device contained in this premarket notification is complete and supports a decision that the test device is substantially equivalent to the predicate device.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

Elitechgroup Epoch Biosciences Debra K. Hutson Director, QA/RA, North America 21720 23rd Dr SE, Suite 150 Bothell, WA 98021 US

October 17, 2013

Re: K132468

Trade/Device Name: MRSA/SA ELITe MGB® Software Regulation Number: 21 CFR 866.1640 Regulation Name: Antimicrobial Susceptibility Test Powder Regulatory Class: II Product Codes: NOX, NSU, JJH Dated: August 5, 2013 Received: August 7, 2013

Dear Debra Hutson:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

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 CFR Part 807); labeling (21 CFR Parts 801 and 809); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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If you desire specific advice for your device on our labeling regulations (21 CFR Parts 801 and 809), please contact 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/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR 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/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours.

Uwe Scherf -S for

Sally A. Hojvat, 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

510(k) Number (if known): K132468

Device Name: MRSA/SA ELITe MGB®

Indications For Use:

MRSA/SA ELITe MGB® is a qualitative in vitro diagnostic test for the direction of Staphylococcus aureus (SA) and methicillin-resistant Staphylococcus aureus (MRSA) using DNA purified from nasal swabs. MRSA/SA ELITe MGB® is intended to aid in the prevention and control of MRSA infections in healthcare settings. It is not intended to diagnose, quide or monitor MRSA infections, or provide results of susceptibility to oxacillin/methicillin. A negative result does not preclude MRSA/SA (Staphylococcus aureus) nasal colonization. Concomitant cultures are necessary to recover organisms for epidemiological typing or for further susceptibility testing.

Prescription Use × (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 Diagnostics and Radiological Health (OIR)

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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).