Who is the manufacturer of VITEK MS PRIME?

bioMerieux, Inc. filed the 510(k) submission for VITEK MS PRIME (K212461).

What is the FDA product code for VITEK MS PRIME?

QBN. It is classified under 21 CFR 866.3378 as a Class 2 device in the Microbiology panel.

What is the regulatory pathway for VITEK MS PRIME?

510(k) clearance (submission type: Traditional).

Who can help prepare an FDA 510(k) submission like VITEK MS PRIME?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

VITEK MS PRIME

K212461 · bioMerieux, Inc. · QBN · Mar 15, 2022 · Microbiology

Device Facts

Record ID	K212461
Device Name	VITEK MS PRIME
Applicant	bioMerieux, Inc.
Product Code	QBN · Microbiology
Decision Date	Mar 15, 2022
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 866.3378
Device Class	Class 2

Indications for Use

VITEK® MS PRIME is a mass spectrometry system using matrix-assisted laser desorption/ionization time of flight mass spectrometry (MALDI-TOF MS) for the identification of microorganisms cultured from human specimens. The VITEK® MS PRIME system is a qualitative in vitro diagnostic device indicated for use in conjunction with other clinical and laboratory findings to aid in the diagnosis of bacterial and fungal infections.

Device Story

VITEK MS PRIME is a benchtop MALDI-TOF mass spectrometry system for clinical microbiology laboratories. It identifies microorganisms from cultured human specimens. Users prepare samples on VITEK MS-DS target slides, adding matrix for laser sublimation. The system uses a 349 nm Nd:YLF laser to ionize samples; ionized molecules are accelerated in an electromagnetic field. A detector measures time-of-flight to determine mass-to-charge (m/z) ratios, generating a mass spectrum. The system compares this spectrum against the VITEK MS Knowledge Base (v3.2) to identify the organism at the genus and species level. The device features a 'load and go' approach for up to 16 slides with prioritization. Results assist clinicians in diagnosing infections, enabling faster and more accurate pathogen identification compared to traditional methods, which can improve patient management and treatment decisions.

Clinical Evidence

Clinical study evaluated 500 clinical isolates (100 species) and 100 challenge isolates. Performance: 98.4% agreement (95% CI: 96.8-99.3%) for clinical isolates. Challenge testing showed 94.0% correct single-choice ID. Reproducibility study (600 tests) showed high consistency. Analytical studies confirmed LoD equivalent to predicate ($10^5$ CFU/spot for bacteria, $10^4$ CFU/spot for yeast).

Technological Characteristics

Benchtop MALDI-TOF mass spectrometer; neodymium-doped yttrium fluoride (YFL) laser; multichannel plate detector; VITEK MS-DS disposable target slides; Knowledge Base v3.2; VITEK FLEXPREP software. Reagents: CHCA matrix, formic acid, acetonitrile, ethanol. Connectivity: LIS/MYLA integration. Software: kiosk-mode, locked OS.

Indications for Use

Indicated for identification of microorganisms cultured from human specimens (bacteria, yeast, moulds, Mycobacteria, Nocardia) to aid in diagnosis of bacterial and fungal infections. For prescription use only.

Regulatory Classification

Identification

A clinical mass spectrometry microorganism identification and differentiation system is a qualitative in vitro diagnostic device intended for the identification and differentiation of microorganisms from processed human specimens. The system acquires, processes, and analyzes spectra to generate data specific to a microorganism(s). The device is indicated for use in conjunction with other clinical and laboratory findings to aid in the diagnosis of bacterial and fungal infection.

Special Controls

Clinical mass spectrometry microorganism identification and differentiation system must comply with the following special controls:

*Classification.* Class II (special controls). The special controls for this device are:(1) The intended use statement must include a detailed description of what the device detects, the type of results provided to the user, the clinical indications appropriate for test use, and the specific population(s) for which the device is intended, when applicable. (2) Any sample collection device used must be FDA-cleared, -approved, or -classified as 510(k) exempt with an indication for in vitro diagnostic use. (3) The labeling required under § 809.10(b) of this chapter must include: (i) A detailed device description, including all device components, control elements incorporated into the test procedure, instrument requirements, ancillary reagents required but not provided, and a detailed explanation of the methodology and all pre-analytical methods for processing of specimens, and algorithm used to generate a final result. This must include a description of validated inactivation procedure(s) that are confirmed through a viability testing protocol, as applicable. (ii) Performance characteristics for all claimed sample types from clinical studies with clinical specimens that include prospective samples and/or, if appropriate, characterized samples. (iii) Performance characteristics of the device for all claimed sample types based on analytical studies, including limit of detection, inclusivity, reproducibility, interference, cross-reactivity, interfering substances, carryover/cross-contamination, sample stability, and additional studies regarding processed specimen type and intended use claims, as applicable. (iv) A detailed explanation of the interpretation of test results for clinical specimens and acceptance criteria for any quality control testing. (4) The device's labeling must include a prominent hyperlink to the manufacturer's website where the manufacturer must make available their most recent version of the device's labeling required under § 809.10(b) of this chapter, which must reflect any changes in the performance characteristics of the device. FDA must have unrestricted access to this website, or manufacturers must provide this information to FDA through an alternative method that is considered and determined by FDA to be acceptable and appropriate. (5) Design verification and validation must include: (i) Any clinical studies must be performed with samples representative of the intended use population and compare the device performance to results obtained from an FDA-accepted reference method and/or FDA-accepted comparator method, as appropriate. Documentation from the clinical studies must include the clinical study protocol (including predefined statistical analysis plan, if applicable), clinical study report, and results of all statistical analyses. (ii) Performance characteristics for analytical and clinical studies for specific identification processes for the following, as appropriate: (A) Bacteria, (B) Yeasts, (C) Molds, (D) Mycobacteria, (E) Nocardia, (F) Direct sample testing ( *e.g.,* blood culture),(G) Antibiotic resistance markers, and (H) Select agents ( *e.g.,* pathogens of high consequence).(iii) Documentation that the manufacturer's risk mitigation strategy ensures that their device does not prevent any device(s) with which it is indicated for use, including incorporated device(s), from achieving their intended use ( *e.g.,* safety and effectiveness of the functions of the indicated device(s) remain unaffected).(iv) A detailed device description, including the following: (A) Overall device design, including all device components and all control elements incorporated into the testing procedure. (B) Algorithm used to generate a final result from raw data ( *e.g.,* how raw signals are converted into a reported result).(C) A detailed description of device software, including validation activities and outcomes. (D) Acquisition parameters ( *e.g.,* mass range, laser power, laser profile and number of laser shots per profile, raster scan, signal-to-noise threshold) used to generate data specific to a microorganism.(E) Implementation methodology, construction parameters, and quality assurance protocols, including the standard operating protocol for generation of reference entries for the device. (F) For each claimed microorganism characteristic, a minimum of five reference entries for each organism (including the type strain for microorganism identification), or, if there are fewer reference entries, a clinical and/or technical justification, determined by FDA to be acceptable and appropriate, for why five reference entries are not needed. (G) DNA sequence analysis characterizing all type strains and at least 20 percent of the non-type strains of a species detected by the device, or, if there are fewer strain sequences, then a clinical and/or technical justification, determined by FDA to be acceptable and appropriate, must be provided for the reduced number of strains sequenced. (H) As part of the risk management activities, an appropriate end user device training program, which must be offered as an effort to mitigate the risk of failure from user error.

Predicate Devices

Vitek MS (K181412)

Related Devices

K181412 — VITEK MS · bioMerieux, Inc. · Dec 21, 2018
DEN130013 — VITEK MS · bioMerieux, Inc. · Aug 21, 2013
K162950 — VITEK MS · bioMerieux, Inc. · Jul 22, 2017

Submission Summary (Full Text)

{0} FDA U.S. FOOD & DRUG ADMINISTRATION # 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY AND INSTRUMENT ## I Background Information: A 510(k) Number K212461 B Applicant bioMerieux, Inc. C Proprietary and Established Names Vitek MS Prime D Regulatory Information | Product Code(s) | Classification | Regulation Section | Panel | | --- | --- | --- | --- | | QBN | Class II | 21 CFR 866.3378 - Clinical Mass Spectrometry Microorganism Identification And Differentiation System | MI - Microbiology | ## II Submission/Device Overview: A Purpose for Submission: Premarket notification for the VITEK MS PRIME. B Measurand: See Intended Use C Type of Test: A mass spectrometer system for clinical use for the identification of microorganisms is a qualitative in vitro diagnostic device intended for the identification of microorganisms cultured from human specimens. The device is comprised of an ionization source, a mass analyzer, and a Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993-0002 www.fda.gov {1} spectral database. The device is indicated for use in conjunction with other clinical and laboratory findings to aid in the diagnosis of bacterial and fungal infections. ## III Intended Use/Indications for Use: ### A Intended Use(s): VITEK MS PRIME is a mass spectrometry system using matrix-assisted laser desorption/ionization time of flight mass spectrometry (MALDI-TOF MS) for the identification of microorganisms cultured from human specimens. The VITEK MS PRIME system is a qualitative in vitro diagnostic device indicated for use in conjunction with other clinical and laboratory findings to aid in the diagnosis of bacterial and fungal infections. The following organisms are claimed: | Gram Negative / Positive Bacteria & Yeast | Bacteroides ovatus / xylanisolvens | | --- | --- | | | Bacteroides pyogenes | | | Bacteroides stercoris | | Abiotrophia defectiva | Bacteroides thetaiotaomicron | | Achromobacter denitrificans | Bacteroides uniformis | | Achromobacter xylosoxidans | Bacteroides vulgatus | | Acinetobacter baumannii | Bifidobacterium spp | | Acinetobacter calcoaceticus | Bilophila wadsworthia | | Acinetobacter haemolyticus | Bordetella avium | | Acinetobacter johnsonii | Bordetella bronchiseptica | | Acinetobacter junii | Bordetella parapertussis | | Acinetobacter lwoffii | Bordetella pertussis | | Acinetobacter nosocomialis | Brevundimonas diminuta | | Acinetobacter pittii | Brevundimonas vesicularis | | Actinomyces bovis | Brucella spp | | Actinomyces israelii | Burkholderia cenocepacia | | Actinomyces meyeri | Burkholderia cepacia | | Actinomyces naeslundii | Burkholderia contaminans | | Actinomyces neuii | Burkholderia gladioli | | Actinomyces odontolyticus | Burkholderia multivorans | | Actinotignum schaalii | Burkholderia vietnamiensis | | Aerococcus viridans | Campylobacter coli | | Aeromonas hydrophila | Campylobacter jejuni | | Aeromonas jandaei | Campylobacter rectus | | Aeromonas punctata (caviae) | Candida albicans | | Aeromonas sobria | Candida auris | | Aeromonas veronii | Candida dubliniensis | | Aggregatibacter | Candida duobushaemulonii | | actinomycetemcomitans | Candida famata | | Aggregatibacter aphrophilus | Candida glabrata | | Aggregatibacter segnis | Candida guilliermondii | | Alcaligenes faecalis ssp faecalis | Candida haemulonii | | Bacteroides caccae | Candida inconspicua | | Bacteroides eggerthii | Candida intermedia | | Bacteroides fragilis | Candida kefyr | K212461 - Page 2 of 29 {2} K212461 - Page 3 of 29 Candida krusei Enterobacter cloacae Candida lamlica Enterobacter asburiae Candida lipolytica Enterobacter cancerogenus Candida lusitaniae Enterobacter cancerogenus Candida metapsilosis Enterobacter homeechei Candida norvegensis Enterobacter kobei Candida orthopsilosis Enterobacter ludwigii Candida parapsilosis Enterococcus avium Candida pelliculosa Enterococcus casseliflavus Candida rugosa Enterococcus durans Candida parapsilosis Enterococcus faecium Candida pelliculosa Enterococcus gallinarum Candida rugosa Enterococcus hirae Candida tropicalis Escherichia bergsonii Candida utilis Escherichia hermannii Candida zeyranoides Escherichia coli Cedecea davisae Escherichia hermannii Cedecea neevan Escherichia coli Cedecea lapaei Escherichia hermannii Cedecea neteri Escherichia coli Chryseobacterium gelum Escherichia hermannii Chryseobacterium amlodogenes Escherichia hermannii Citrobacter amalonaticus Escherichia hermannii Citrobacter braakii Escherichia hermannii Citrobacter farmeri Escherichia hermannii Citrobacter freundii Escherichia hermannii Citrobacter koseri Escherichia hermannii Citrobacter youngae Escherichia hermannii Clostridium baratii Escherichia hermannii Clostridium beijerinckii Escherichia hermannii Clostridium butyricum Escherichia hermannii Clostridium cadaveris Escherichia hermannii Clostridium clostridioforme Escherichia hermannii Clostridium difficile Escherichia hermannii Clostridium innocuum Escherichia hermannii Clostridium novyi Escherichia hermannii Clostridium perfringens Escherichia hermannii Clostridium ramosum Escherichia hermannii Clostridium septicum Escherichia sporo genes Clostridium sporoigenes Escherichia teretium Clostridium tetani Escherichia tetani Comamonas testosteroni Comamonas testosteroni Corynebacterium jeikeium Corynebacter usytocosi Cronobacter sakazakii Cronobacter turicensis Cronobacter turicensis Cryptococcus gattii Cryptococcus neoformans Cryptococcus neoformans Curtobacterium flaccumfaciens Curtobacterium flaccumfaciens Delftia acidovorans Delftia acidovorans Edwardsiella hoshinae Edwardsiella tarda Edwardsiella corrodens Edwardsiella corrodens Elizabethkingia anophelis Elizabethkingia meningoseptica Elizabethkingia miricola Elizabethkingia miricola Enterobacter aerogenes Enterobacter aerogenes {3} K212461 - Page 4 of 29 Moraxella catarrhalis Moraxella lacunata Moraxella nonliquefaciens Moraxella osloensis Morganella morganii Myroides spp Neisseria cinerea Neisseria gonorrhoeae Neisseria meningitidis Neisseria mucosa / sicca Ochrobactrum anthropi Oligella ureolytica Oligella urethralis Paeniclostridium sordellii Pantoea agglomerans Pantoea dispersa Paraclostridium bifermentans Parvimonas micra Pasteurella aerogenes Pasteurella multocida Pediococcus acidilactici Peptoniphilus asaccharolyticus Peptostreptococcus anaerobius Plesiomonas shigelloides Pluralibacter gergoviae Porphyromonas asaccharolytica / uenonis Porphyromonas gingivalis Prevotella bivia Prevotella buccae Prevotella denticola Prevotella intermedia Prevotella loescheii Prevotella melaninogenica Prevotella oralis Prevotella oris Propionibacterium acidipropionici Propionibacterium acnes Propionibacterium avidum Propionibacterium granulosum Propionibacterium propionicum Proteus mirabilis Proteus penneri Proteus vulgaris Providencia alcalifaciens Providencia rettgeri Providencia rustigianii Providencia stuartii Pseudomonas aeruginosa Pseudomonas alcaligenes Pseudomonas fluorescens Pseudomonas luteola Pseudomonas mendocina Pseudomonas oryzihabitans Pseudomonas putida Pseudomonas stutzeri Ralstonia pickettii Raoultella ornithinolytica Raoultella planticola Raoultella terrigena Rhizobium radiobacter Rhodotorula mucilaginosa Rothia mucilaginosa Saccharomyces cerevisiae Salmonella enterica ssp enterica Saprochaete capitata Serratia ficaria Serratia fonticola Serratia grimesii Serratia liquefaciens Serratia marcescens Serratia odorifera Serratia plymuthica Serratia proteamaculans Serratia quinivorans Serratia rubidaea Shewanella putrefaciens Sphingobacterium multivorum Sphingobacterium spiritivorum Sphingomonas paucimobilis Staphylococcus aureus Staphylococcus auricularis Staphylococcus capitis Staphylococcus chromogenes Staphylococcus cohnii ssp cohnii Staphylococcus cohnii ssp urealyticus Staphylococcus epidermidis Staphylococcus haemolyticus Staphylococcus hominis Staphylococcus hyicus Staphylococcus intermedius Staphylococcus pseudintermedius Staphylococcus kloosii Staphylococcus lentus Staphylococcus lugdunensis Staphylococcus saprophyticus Staphylococcus schleiferi Staphylococcus sciuri Staphylococcus simulans Staphylococcus warneri Staphylococcus xylosus Stenotrophomonas maltophilia Streptococcus agalactiae Streptococcus alactolyticus Streptococcus anginosus Streptococcus canis Streptococcus constellatus Streptococcus cristatus Streptococcus dysgalactiae ssp dysgalactiae {4} K212461 - Page 5 of 29 Streptococcus dysgalactiae ssp equisimilis Streptococcus equi ssp equi Streptococcus equi ssp zooepidemicus Streptococcus equi ssp ruminatorum Streptococcus equinus Streptococcus gallolyticus ssp gallolyticus Streptococcus gallolyticus ssp pasteurianus Streptococcus gordonii Streptococcus infantarius ssp coli (Str.lutetiensis) Streptococcus infantarius ssp infantarius Streptococcus intermedius Streptococcus mitis / Streptococcus oralis Streptococcus mutans Streptococcus parasanguinis Streptococcus pneumoniae Streptococcus pseudoporcinus Streptococcus pyogenes Streptococcus salivarius ssp salivarius Streptococcus sanguinis Streptococcus sobrinus Streptococcus suis Streptococcus uberis Streptococcus vestibularis Tannerella forsythia Veillonella dispar Vibrio alginolyticus Vibrio cholerae Vibrio fluvialis Vibrio metschnikovii Vibrio mimicus Vibrio parahaemolyticus Vibrio vulnificus Yersinia aldovae Yersinia enterocolitica Yersinia frederiksenii Yersinia intermedia Yersinia kristensenii Yersinia pseudotuberculosis Yersinia ruckeri ## Mycobacterium Mycobacterium abscessus Mycobacterium avium Mycobacterium chelonae Mycobacterium fortuitum group Mycobacterium gordonae Mycobacterium haemophilum Mycobacterium immunogenum Mycobacterium intracellulare Mycobacterium kansasii Mycobacterium lentiflavum Mycobacterium malmoense Mycobacterium marinum Mycobacterium mucogenicum Mycobacterium scrofulaceum Mycobacterium simiae Mycobacterium smegmatis Mycobacterium szulgai Mycobacterium tuberculosis complex Mycobacterium xenopi ## Nocardia Nocardia abscessus Nocardia africana / nova Nocardia asteroides Nocardia brasiliensis Nocardia cyriacigeorgica Nocardia farcinica Nocardia otitidiscaviarum Nocardia paucivorans Nocardia pseudobrasiliensis Nocardia transvalensis Nocardia veterana Nocardia wallacei ## Mould Acremonium sclerotigenum Alternaria alternata Aspergillus brasiliensis Aspergillus calidoustus / ustus Aspergillus flavus / oryzae Aspergillus fumigatus Aspergillus lentulus Aspergillus nidulans Aspergillus niger complex Aspergillus sydowii Aspergillus terreus complex Aspergillus versicolor Blastomyces dermatitidis Cladophialophora bantiana Coccidioides immitis / posadasii Curvularia hawaiiensis Curvularia spicifera Epidermophyton floccosum Exophiala dermatitidis Exophiala xenobiotica Exserohilum rostratum Fusarium oxysporum complex Fusarium proliferatum Fusarium solani complex Histoplasma capsulatum Lecythophora hoffmannii Lichtheimia corymbifera {5} K212461 - Page 6 of 29 Microsporum audouinii Scedosporium apiospermum Microsporum canis Scedosporium prolificans Microsporum gypseum Sporothrix schenckii complex Mucor racemosus complex Trichophyton interdigitale Paecilomyces variotii complex Trichophyton rubrum Penicillium chrysogenum Trichophyton tonsurans Pseudallescheria boydii Trichophyton verrucosum Purpureocillium lilacinum Trichophyton violaceum Rasamsonia argillacea complex Trichosporon asahii Rhizopus arrhizus complex Trichosporon dermatis / mucoides Rhizopus microsporus complex Trichosporon inkin Sarocladium kiliense B Indication(s) for Use: See Intended Use C Special Conditions for Use Statement(s): Rx - For Prescription Use Only D Special Instrument Requirements: VITEK MS PRIME System IV Device/System Characteristics: A Device Description: The VITEK MS PRIME system is a benchtop system consisting of kit reagents (VITEK MS-CHCA, VITEK MS-FA, VITEK MS Mycobacterium/Nocardia Kit, VITEK MS Mould Kit), VITEK MS-DS target slides, Knowledge Base v3.2 reference database, VITEK FLEXPREP software, and the VITEK MS PRIME instrument and associated software. Reagent Description: - The VITEK MS-CHCA (Alpha-cyano-4-hydroxy-cinnamic acid) is a solution that serves as a matrix which will crystalize with the microbial sample on the target slide spot. One microliter of the matrix is added to the spot with the sample and allowed to dry forming crystals. - The VITEK MS-FA (Formic acid) reagent is used to pre-treat yeast in order to extract protein before the VITEK MS-CHCA matrix is added to the spot containing the sample. - The VITEK MS MYCOBACTERIUM/NOCARDIA KIT includes ethanol and vials with glass beads to inactivate Mycobacterium and Nocardia species by disrupting the cells. The kit also includes formic acid and acetonitrile to complete the extraction of proteins. - The VITEK MS MOULD KIT method uses ethanol, formic acid, and acetonitrile to inactivate molds and extract their proteins. - The Brucella inactivation solvent mixture contains API Suspension Medium or sterile deionized water, absolute ethanol (HPLC grade), acetonitrile (HPLC grade), and trifluoroacetic acid (TFA) (HPLC grade). VITEK MS-DS Target Slides: {6} VITEK MS-DS target slides are single-use disposable slides which contain three acquisition groups of 16 sample spots. Each group includes one calibration spot. ## Knowledge Base: The reference database for the VITEK MS system includes data representing 1316 species and 1158 taxa displayed. VITEK MS Knowledge Base v3.2.0 includes 1095 species of bacteria (863 single species and 77 groups including 232 species) and 221 species of fungi (195 single species and 12 groups including 26 species). Additional laboratory tests as determined by microbiology laboratory protocols for low discrimination results or non-clinically validated organisms are necessary for the completion of the organism identification. Non-clinically validated organisms are displayed as (N) in the report. ## Software: The VITEK MS PRIME system consists of a suite of applications that perform the overall system function. The system functions as a kiosk, not allowing the end-user to access any operating system functions. The end-user cannot access the native operating system, or any system configuration panels. The software application contains several processes that include handling all user interactions, all network activity, communication, and synchronization with all the components. At a general level, the VITEK MS System / Software controls: - The VITEK MS PRIME workflow management (which includes connection with a Preparation Station (called FLEXPREP)) - The identification computation engine (and its' interface with the VITEK MS knowledge base) - The identification results review functionality - Communication with the LIS/MYLA - The prepared slides supervision - Customer reports creation (e.g., QC reports, isolate reports, spot and usage reports) as well as the data export) - High level system supervision (display alarms, alerts for each sub systems) ## VITEK MS PRIME instrument: The VITEK MS PRIME instrument is a MALDI-ToF mass spectrometer that is a benchtop model with a smaller footprint than the predicate VITEK MS instrument. ## B Principle of Operation: With the VITEK MS PRIME System, microorganism identification is made via matrix-assisted laser desorption/ionization (time of flight mass spectrometry (MALDI-TOF MS)) technology, which includes the three basic principles of ionization, separation, and detection. As a first step, a VITEK MS-DS Target Slide is prepared in accordance with the instructions for use. K212461 - Page 7 of 29 {7} Once the specimen (cultured from the appropriate media) is spotted to the target slide, a matrix is added for the purpose of easy sublimation and strong absorbance in the laser wavelength employed by the instrument. The prepared slide is then loaded onto the VITEK MS PRIME instrument, where a laser targets the sample spot and pulses the isolate spot, resulting in vibrational excitation of matrix and analyte molecules. The matrix transfer protons to the analyte resulting in a positive charge. So as part of the first basic principle, the ionized molecules are then accelerated in an electromagnetic field and a grid electrode in the ionization chamber. The acceleration in the electromagnetic field is the beginning of the second basic principle (i.e. the separation process that is based on the time-of-flight principle). The velocity of the molecules depends on the mass-to-charge (m/z) ratio of the analyte, with heavier molecules having a higher moment of inertia resulting in a lower velocity. As a final step in the basic principle of MALDI-ToF technology (i.e. detection) the time of flight is measured precisely by the ions arrival at a particle detector. This speed of the ions in flight depends on their mass - with heavier molecules having a higher moment of inertia resulting in a lower velocity. The time of transit is measured precisely by the ions' arrival at a particle detector. Based on the time of flight, the m/z ratio of each particle can be determined, and a mass spectrum of the analyte sample mixture is generated. The recorded signal is processed and presented as a spectrum of intensity versus mass in Daltons (Da). The mass spectrum displays results as a series of peaks (spectrum) which correspond to the ionized proteins derived from the analyte sample. And for identification of an unknown organism, the resulting mass spectra are sufficiently distinctive to allow taxonomic characterization at the genus and species when compared against the VITEK MS Knowledge Base v3.2. ## C Instrument Description Information: 1. Instrument Name: VITEK MS PRIME System 2. Specimen Identification: Same as K181412 3. Specimen Sampling and Handling: Manual process 4. Calibration: Escherichia coli ATCC 8739 strain is used for calibration for each test plate. 5. Quality Control: Per manufacturer's instructions (See Section VII(A)(6) below) K212461 - Page 8 of 29 {8} V Substantial Equivalence Information: A Predicate Device Name(s): Vitek MS B Predicate 510(k) Number(s): K181412 C Comparison with Predicate: | Item | | Predicate: | | --- | --- | --- | | Similarities | | | | Intended Use Same – the only difference is that for the VITEK MS PRIME the yeast and mould were simplified / combined to indicate “fungal.”) | VITEK MS PRIME is a mass spectrometry system using matrix-assisted laser desorption / ionization time of flight mass spectrometry (MALDI-TOF S) for the identification of microorganisms cultured from human specimens. The VITEK MS PRIME system is a qualitative in vitro diagnostic device indicated for use in conjunction with other clinical and laboratory findings to aid in the diagnosis of bacterial and fungal infections. (For a list of FDA Indications for Use see Section 1.5 of this 510(k)) | VITEK MS is a mass spectrometry system using matrix-assisted laser desorption / ionization time of flight mass spectrometry (MALDI-TOF MS) for the identification of microorganisms cultured from human specimens. The VITEK MS PRIME system is a qualitative in vitro diagnostic device indicated for use in conjunction with other clinical and laboratory findings to aid in the diagnosis of bacterial, yeast and mould infections. (For a list of FDA Indications for Use see 510(k) K181412) | | Where Used | Clinical laboratories | Same | | Test Methodology | Use of MALDI-TOF MS technology for microorganism identification, as a qualitative in vitro diagnostic device to be used in conjunction with other clinical and laboratory findings to aid in the diagnosis of bacterial and fungal infections | Same | | Analyte Tested | Microorganisms cultured from human specimens. The bacterial and fungal cultures are from solid media, or in the case of Mycobacteria may be isolated from either solid or liquid media. | Same | | Preparation Reagents / Components / Set Up Methods | • CHCA Matrix • FA Reagent • VITEK MS DS Target Slides • Myco. / Nocardia Preparation Kit (and liquid media components for Mycobacteria) • Mould Preparation Kit | Same | | Knowledge Base | KB v3.2 | Same | K212461 - Page 9 of 29 {9} | Item | Device: VITEK MS PRIME | Predicate: VITEK MS (K181412) | | --- | --- | --- | | **Differences** | | | | Instrument | 1. Benchtop model – with shorter flight tube 2. Laser - neodymium-doped yttrium fluoride lasing (YFL) laser 3. Multichannel plate detector in a photomultiplier tube 4. Optics are on access for irradiation 5. Load and go approach for loading slides onto the system – system can load up to 16 slides with the option for slide prioritization. | 1. Floor standing model – with longer flight tube 2. Nitrogen based 3. Multiple dynode detector 4. Optics used for irradiation are asymmetrical of deflectors 5. Maximum of four slides can be loaded onto the instrument (slides must be read in the order that they were loaded). | | Accelerated ions | Cations | Cations and anions | | Rastering Pattern | Continuous boustrophedon raster path across the slide spot. The “profile” for the sample is defined as an average of 50 spectra obtained by as many consecutive laser shots (this averaging is done in “real-time” by the digitizer hardware). This means that the number of shots on a given spot type does not vary. Sample spots always get 7,300 shots, which comes out to a possible 146 profiles. The final spectrum is created by averaging the resulting profiles. A “good spectrum” is any spectrum average that is greater than 30 unitary profiles. | Rastering is accomplished by firing the laser at the first raster point (five shots are made to obtain one profile). If the profile is good, then the laser will re-shoot the same spot to acquire a new profile. If there are two consecutive failed profiles, then the laser moves to the next raster point. The acquisition process stops when the target of 100 good profiles is achieved, or when all raster points have been visited. If the final total of good profiles is less than 30 then the acquisition has failed, and if more than 30 good profiles are obtained then the spectrum is OK. | VI Standards/Guidance Documents Referenced: - CLSI M58, "Methods for the Identification of Cultured Microorganisms Using MALDI-TOF Mass Spectrometry, 1st edition" (26-APR-17) - CLSI MMO9-A, "Nucleic Acid Sequencing Methods in Diagnostic Laboratory Medicine; Approved Guideline, 2nd edition" (14-AUG-2015) - CLSI MM18, "Interpretive Criteria for Identification of Bacteria and Fungi by DNA Target Sequencing; Approved Guideline, 2nd edition" (JUL-2018) - CLSI M35-A2, "Abbreviated Identification of Bacteria and Yeast, Approved Guideline, 2nd edition" (24-NOV-2008) - CLSI EPO9-A3, "Measurement Procedure Comparison and Bias Estimation Using Patient Samples; Approved Guideline, 3rd edition" (30-AUG-2013) - CLSI EP12-A2, "User Protocol for Evaluation of Qualitative Test Performance; Approved Guideline, 2nd edition" (25-JAN-2008) K212461 - Page 10 of 29 {10} - IEC 61010 -1:2010 (Amendment 1:2016), "Safety Requirements for Electrical Equipment for Measurement, Control, and Laboratory Use - Part 1: General Requirements, Edition 3.1" (JAN 2017) - IEC 60601-1-1-2:2014-02, "Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests, 4th edition" (FEB 2014) - IEC 60825-1:2014 "Safety of laser products - Part 1: Equipment classification, and requirements, Edition 3" (15-MAY-2014) ## VII Performance Characteristics (if/when applicable): ## A Analytical Performance: ### 1. Precision/Reproducibility: System reproducibility was determined by testing bacteria, yeasts, Nocardia and mould strains, as determined in the previous V2.0 and V3.0 VITEK MS studies. A total of 10 strains were included in the reproducibility set (6 routine bacteria strains, 2 yeast strains, 1 Nocardia strain and 1 mould strain). Testing was conducted on three instrument systems, with one instrument at one internal testing site and two instruments at another internal testing site. Each of the organisms of the reproducibility panel were tested in duplicate (from separately prepared samples) in each of two runs on the VITEK MS PRIME, on five separate days (not necessarily consecutive), by two technologists on each instrument for a total of 60 tests per organism. Each day of testing, samples were positioned on the target slide in sequential order by sample number by one technologist and positioned on the target slide in random order by a second technologist. The two technologists alternated the sequential and randomized order of testing on subsequent test days. Results from the Reproducibility Study are presented in Table 1. A summary of repeat testing (e.g., due to No ID, bad spectrum during acquisition) is presented in Table 2. | Day | | | | | | | | | --- | --- | --- | --- | --- | --- | --- | --- | | Organism | 1 | 2 | 3 | 4 | 5 | Total (%) | 95% CI | | Enterobacter aerogenes | 12/12 | 12/12 | 12/12 | 12/12 | 12/12 | 60/60 (100.0%) | [94.0, 100.0]% | | Pseudomonas aeruginosa | 12/12 | 12/12 | 12/12 | 12/12 | 12/12 | 60/60 (100.0%) | [94.0, 100.0]% | | Staphylococcus aureus | 12/12 | 12/12 | 12/12 | 12/12 | 12/12 | 60/60 (100.0%) | [94.0, 100.0]% | | Streptococcus agalactiae | 9/12* | 12/12 | 12/12 | 12/12 | 12/12 | 57/60 (95.0%) | [86.1, 99.0]% | | Klebsiella oxytoca | 12/12 | 12/12 | 12/12 | 12/12 | 12/12 | 60/60 (100.0%) | [94.0, 100.0]% | K212461 - Page 11 of 29 {11} Table 2: Reproducibility Study, Summary of Repeat Testing | Repro Species Code | N | Spot Repeat (Percent) | | --- | --- | --- | | Enterobacter aerogenes | 60 | 2 (3.3%) | | Nocardia farcinica | 60 | 4 (6.7%) | | Pseudomonas aeruginosa | 60 | 1 (1.7%) | | Staphylococcus aureus | 60 | 0 (0.0%) | | Streptococcus agalactiae | 60 | 17 (28.3%) | | Klebsiella oxytoca | 60 | 4 (6.7%) | | Candida albicans | 60 | 0 (0.0%) | | Candida glabrata | 60 | 0 (0.0%) | | Escherichia coli | 60 | 1 (1.7%) | | Aspergillus brasiliensis | 60 | 2 (3.3%) | | Total | 600 | 31 (5.2%) | # 2. Linearity: Not applicable, qualitative assay. # 3. Analytical Specificity: An exclusivity study was conducted to evaluate the identifications obtained with VITEK MS PRIME when testing species that are not included in the KB V3.2. A total of 50 species were evaluated in the study, with testing in triplicate. A selection of representative species was made among the species tested during the previous studies done for VITEK MS KB V3.0 and KB V3.2. Those species are listed in the VITEK MS KB 3.2 user manuals as not identified and/or as cross-identified with closely related species or species from the same genus. Additional strains were also tested to ensure inclusion of representatives of each microorganism group: gram-positive bacteria, gram-negative bacteria, Mycobacterium, Nocardia, yeasts, and moulds. The selected organisms also included non-BSL3 species which are phylogenetically close to Brucella species and that have been reported to be misidentified as Brucella in the literature. Exclusivity testing results: K212461 - Page 12 of 29 {12} - 42 species not included in the KB V3.2 database and not included in a complex gave either No Identification results or an identification to closely related species (same genus but different species). - 8 species not included in the KB V3.2 database but included in a complex generated a result of either No Identification or Single choice ID to the expected species/complex. - Brucella cross-identification results: As expected, testing did not result in a Brucella identification with VITEK MS PRIME. All strains tested were identified to the proper species both with direct deposit and Brucella protocols. 4. Equivalency Study: A biological equivalency study was performed to evaluate the clinically validated species that are included in the VITEK MS Knowledge Base (most recent clearance in K181412). The study consisted of testing 477 claimed species represented by 400 displayed labels on the VITEK MS PRIME system, using one well-characterized strain per species. Two species (Coccidiodes immitis and Coccocidiodes posadasii) of the 479 total claimed species in the VITEK MS Knowledge Base were not evaluated due to the lack of available strains. The 477 microorganisms evaluated in the study include gram-positive aerobic and anaerobic bacteria, gram-negative aerobic and anaerobic bacteria (including Brucella species), yeasts, moulds, Mycobacterium species and Nocardia species. Testing was conducted in triplicate for each of the 477 species, for a total of 1461 test spots evaluated: - 467 species tested in triplicate: 1401 results - Ten species tested in six replicates: 60 results - Nine Mycobacteria: three replicates from solid medium and three replicates from liquid medium - One Cronobacter muytjensii: six replicates The results obtained with VITEK MS PRIME were compared to the results previously obtained with VITEK MS using KB v3.2 (predicate device). Study results demonstrated that 98.1% (1433/1461) of tests generated the expected identification (i.e., results including either correct single choice ID or low discrimination to the correct genus). NOTE: For Klebsiella variicola on VITEK MS PRIME, all three replicates of the initial strain evaluated were misidentified as K. pneumoniae. Three additional strains of K. variicola were also misidentified as K. pneumoniae. A limitation is included in the VITEK MS PRIME 3.2 Knowledge Base User Manual indicating that Klebsiella variicola was misidentified as Klebsiella pneumoniae by VITEK MS PRIME and should not be considered as a clinically validated organism for this instrument system. For each organism group evaluated in the Biological Equivalency Study, VITEK MS PRIME testing met the performance acceptance criteria of higher than 95% correct identification (correct single choice ID or low discrimination to the correct genus) for each microorganism group. Results are presented in Table 3. A summary of repeat testing rates is presented in Table 4. K212461 - Page 13 of 29 {13} Table 3: Biological Equivalency Results | VITEK MS PRIME Identification | Total Correct Genus ID (One Choice and Low Discrimination) | One Choice Correct: Genus ID Correct: Species ID or Group/Complex ID | Low Discrimination Correct: Genus ID | Discordant ID^{2} | No ID | | --- | --- | --- | --- | --- | --- | | Organism Group | | | | | | | Gram-positive bacteria | 99.0% (395/399) | 93.50% (373/399) | 5.50% (22/399) | 0% (0/399) | 1.0% (4/399) | | Gram-negative bacteria (including Brucella) | 97.2% (624/642) | 87.7% (563/642) | 9.5% (61/642) | 0.8% (5/642) | 2.0% (13/642) | | Yeasts | 100% (108/108) | 99.1% (107/108) | 0.9% (1/108) | 0% (0/108) | 0% (0/108) | | Moulds^{1} | 97.4% (152/156) | 93.6% (146/156) | 3.8% (6/156) | 0% (0/156) | 2.6% (4/156) | | Mycobacterium liquid | 97.62% (82/84) | 97.62% (82/84) | 0% (0/84) | 0% (0/84) | 2.38% (2/84) | | Mycobacterium solid | 100% (33/33) | 100% (33/33) | 0% (0/33) | 0% (0/33) | 0% (0/33) | | Nocardia | 100% (39/39) | 100% (39/39) | 0% (0/39) | 0% (0/39) | 0% (0/39) | | Total | 98.1% (1433/1461) | 91.9% (1343/1461) | 6.2% (90/1461) | 0.3% (5/1461) | 1.6% (23/1461) | Two species from the 479 claimed species (Coccidioides immitis and C. posadasii) were not tested due to lack of available strains. There were five discordant identifications during the VITEK MS PRIME biological equivalency study. The five misidentifications included the following: **Species Tested** Citrobacter youngae Serratia grimesii Klebsiella variicola Klebsiella variicola Klebsiella variicola **Species Identified** Citrobacter braakii Serratia liquefaciens Klebsiella pneumoniae Klebsiella pneumoniae Klebsiella pneumoniae Table 4: Equivalency Study, Repeat Testing Rate | Organism Classification | | N | Spot Repeat (Percent) | | --- | --- | --- | --- | | Gram+ Bacteria | Aerobic | 276 | 17 (6.2%) | | | Anaerobic | 123 | 9 (7.3%) | | Gram- Bacteria | Aerobic | 546 | 55 (10.1%) | | | Anaerobic | 96 | 9 (9.4%) | | Yeasts | Aerobic | 108 | 7 (6.5%) | | Moulds | Moulds | 156 | 54 (34.6%) | | Myco/Nocardia | Mycobacteria | 117 | 22 (18.8%) | | | Nocardia | 39 | 1 (2.6%) | | ~All~ | Total | 1461 | 174 (11.9%) | K212461 - Page 14 of 29 {14} K212461 - Page 15 of 29 5. Assay Reportable Range: Not applicable, qualitative assay. 6. Traceability, Stability, Expected Values (Controls, Calibrators, or Methods): **Calibrator:** E. coli ATCC 8739 is used as a calibrator. This organism is deposited with VITEK MS-CHCA matrix on up to three plate positions on the VITEK MS-DS target slides depending on the number of samples tested (one calibrator per acquisition group of 16 spots). The VITEK MS PRIME goes to the calibration spot in an acquisition group and performs a calibration. If the calibration passes, the instrument goes to the first spot in the acquisition group. If the calibration fails, an error is reported and VITEK MS PRIME proceeds to the next acquisition group without collecting sample spectra. After spectra have been acquired from each sample spot in an acquisition group, the calibration spot is checked again. The calibration sample should provide E. coli identification at 99.9% in the VITEK MS Software. **Sample Stability on Target Slide:** A study was conducted to evaluate the deposit stability on the slide after matrix addition. The study assessed the following conditions: f: - Part 1: Length of time that the slide (after deposit and matrix addition) can stay in the instrument carousel before being read (stability inside the instrument, 16 hours was selected as the worst-case testing delay that may occur when testing a full rack of 16 slides.) - Part 2: Length of time that the slide (after deposit and matrix addition) can be stored on the bench before the introduction into VITEK MS PRIME instrument (stability outside the instrument). The study covered all microorganism groups including bacteria (30 species), yeast (5 species), moulds (6 species), Brucella-like species (1 strain), Nocardia (2 species for Part 1, 16 additional Nocardia strains for Part 2) and Mycobacterium (6 species). Testing was conducted in duplicate for each strain initially (T0, without testing delays) as well as at T72, T72+8.5 hours, and T72+16 hours. The acceptance criteria for the study included a minimum overall 90% correct identification for all tests performed for each microorganism group. The results from Part 1 of the study showed that fresh deposits were stable inside the instrument up to 16 hours for all groups of microorganisms: bacteria, yeast, Brucella-like species, moulds, Nocardia species and Mycobacterium species. Stability was validated for Mycobacterium species using both liquid and solid media. The results from Part 2 of the study demonstrated deposit stability outside the instrument when combined with 16 hours inside the instrument for the following: - Up to 72h for bacteria, yeast, Brucella-like species and Mycobacterium species from liquid and solid media. - Up to 48h for moulds and Nocardia species. {15} # Controls: The following Positive Quality Control organisms are recommended in the VITEK MS PRIME User Manual. | Organism Type | Quality Control Strain | Expected Results | | --- | --- | --- | | Bacteria | Klebsiella (Enterobacter) aerogenes ATCC 13048 | Klebsiella aerogenes | | Yeast | Candida glabrata ATCC MYA-2950 | Candida glabrata | | Mycobacteria | Mycoicibacterium smegmatis ATCC 19420 | Mycoicibacterium smegmatis | | Nocardia | Nocardia farcinica ATCC 3308 | Nocardia farcinica | | Moulds | Aspergillus brasiliensis ATCC 16404 | Aspergillus brasiliensis | | Brucella | Brucella melitensis ATCC 23456 | Brucella spp. | | Negative Control | Reagent Alone (Bacteria - CHCA; Yeast-FA and CHCA; Mould, Mycobacteria and Nocardia – FA, acetonitrile and CHCA | No ID | During the validation studies conducted for the VITEK MS PRIME, five of the above recommend positive control organisms were used for quality control testing. Brucella meletensis was not tested in the study. Negative control testing included testing of reagents, as applicable depending on the microorganism group being evaluated at the time of testing. During validation studies, applicable quality control organisms were tested by VITEK MS PRIME each day a bacterium, yeast or mould was tested as well as with each new batch of VITEK MS-CHCA or VITEK MS-DS target slides. During the Clinical Study, Challenge and Reproducibility studies, quality control testing was conducted at each clinical study site. Quality Control testing results are presented in Table 5. The overall repeat rate was 1.5%. K212461 - Page 16 of 29 {16} Table 5: Quality Control Testing Results, Clinical, Challenge and Reproducibility Studies. | QC Species | N | Correct One Choice (or No ID for Negative Control) | Percent Correct | | --- | --- | --- | --- | | Aspergillus brasiliensis | 81 | 80 | 98.8% | | Candida glabrata | 61 | 61 | 100% | | Klebsiella (Enterobacter) aerogenes | 77 | 76 | 98.7% | | Mycobacterium smegmatis | 45 | 42 | 93.3% | | Nocardia farcinica | 63 | 61 | 96.8% | | Negative control (reagents alone) | 130 | 130 | 100% | 7. Detection Limit: A limit of detection (LoD) study with the VITEK MS PRIME was conducted to verify the detection limit was at least equivalent to the LoD established on the VITEK MS, which is $10^{5}$ CFU/spot $(1\ \mu\mathrm{L})$ for bacteria and $10^{4}$ CFU/spot $(1\ \mu\mathrm{L})$ for yeast. Five species, representative of the main groups of microorganisms including gram-negative, gram-positive, fastidious bacteria and yeast, were tested to assess the LoD of the VITEK MS PRIME. The limits of detection obtained in this study with VITEK MS PRIME were evaluated at $10^{5}$ CFU/spot $(1\ \mu)$ for bacteria and $10^{4}$ CFU/spot $(1\ \mu)$ for yeast. The LoD values obtained with the VITEK MS PRIME are comparable to those obtained with the VITEK MS. The acceptance criteria were met. 8. Assay Cut-Off: See K181412 - Both VITEK MS and VITEK MS PRIME systems use the same analysis algorithms and Knowledge Base. 9. VITEK MS PRIME Automatic Reshoot: The VITEK MS PRIME offers the user the option to configure automatic reshoot(s) on sample spots. When the spectra acquisition does not meet the quality criteria, the system will automatically reshoot the spot. The maximum number of acquisitions per sample is three - one original shot plus two repeat shots. A study was conducted to test conditions of organism spotting that could lead to automatic reshoot of the sample. The study also included evaluation of the biological impact of reshooting on the negative controls such as occurrence of false positive results. The following test conditions that could lead to automatic reshoot of the sample (i.e., conditions that would generate bad quality spectra) were evaluated: - Sample deposits made without CHCA matrix - Testing of negative reagent spots (no organism added) K212461 - Page 17 of 29 {17} - Simulation of incorrect deposits (thick deposit with too much material, thin deposit with too little material) The results of the study demonstrated the reshoot process functioned as expected meeting the acceptance criteria in all test case challenges. No discordant or false positive results were observed following a reshoot. 10. Carry-Over: See DEN130013 11. Impact of Mixed Cultures: Though the intended use of the VITEK MS PRIME is to identify pure cultures, it is possible that mixed cultures may inadvertently be tested by a laboratory technologist. This study assessed the impact of mixed cultures on the identification of bacteria, yeast, moulds, mycobacteria and Nocardia when tested on the VITEK MS PRIME. A minimum of four replicates were evaluated for each organism mixture. Four representative bacterial species (K. aerogenes, P. aeruginosa, S. aureus and C. jeikeium) and one yeast (Candida glabrata) were evaluated in the study. Testing included suspension mixtures with two organisms (one species at a high positive concentration mixed with another species at a moderate positive concentration). For 10 different organism/concentration mixtures (60 total tests) VITEK MS PRIME testing reported the following: - Correct Identification for only one of the organisms in the mixture (58 tests) - Low discrimination with both organisms listed (1 test) - No Identification (1 test). Five representative mould species (Aspergillus brasiliensis, Penicillium chrysogenum, Pseudallescheria boydii, Lecythophora hoffamanni, Epidemophyton floccosum) were evaluated in the study. Testing included suspension mixtures with two different mould species (high positive/low positive). For eight different organism/concentration mixtures (32 total tests), VITEK MS PRIME testing resulted in the following: - Correct Identification for only one of the organisms in the mixture (20) - Low Discrimination with both organisms listed (12) From solid media, nine Mycobacteria, including rapid-growers and slow-growers (M. smegmatis, M. intracellulare, M. abscessus, M. fortuitum, M. chelonae, M. tuberculosis, M. scrofulaceum, M. kansasii, M. fortuitum) and three Nocardia species (N. farcinica, N. asteroides, N. brasiliensis) were evaluated in the study. Testing included suspension mixtures (derived from solid media growth) of two different species (high positive/moderate positive). For 18 different organism/concentration mixtures (72 total tests), VITEK MS PRIME testing resulted in the following: - Correct Identification for only one of the organisms in the mixture (60) - Low Discrimination with both organisms listed (9) - No Identification (3) K212461 - Page 18 of 29 {18} For liquid media, five Mycobacterium spp., two bacterial species and one yeast were evaluated in the study. Testing included suspension mixtures (derived from liquid media growth) of two different species (high positive/moderate positive). For the six different organism/concentration mixtures (24 total tests), VITEK MS PRIME testing resulted in correct identification for only one of the organisms in each mixture evaluated. In summary, no misidentification results occurred for the mixed cultures evaluated. All mixed cultures were identified as either correct single choice ID of one of the two species in the test mixture, low discrimination listing the two organisms, or No ID. For the majority of organism mixtures that generated single choice ID the high-positive organism is identified. Results from the study demonstrate that VITEK MS PRIME algorithm cannot consistently identify both organisms present in a sample. Therefore, as stated in the VITEK PRIME User Manual, users should test pure cultures. ## B Comparison Studies: 1. Method Comparison with Predicate Device: Not applicable 2. Matrix Comparison: Not applicable. ## C Clinical Studies: 1. Clinical Performance: (Refer also to DEN1300013/K124067/K162950/K181412 for additional clinical validation for the VITEK MS Knowledge Base using the predicate device, VITEK MS) The objective of the clinical study was to evaluate the performance of the VITEK MS PRIME for identification of representative microorganisms in a clinical setting as compared to the reference method (DNA sequencing analysis and other methods as necessary, i.e., genotypic and/or phenotypic testing and/or dendrogram analysis). Organisms evaluated in the study included well-characterized aerobic and anaerobic gram-positive and gram-negative bacteria, *Mycobacteria*, *Nocardia*, yeasts, and moulds that were previously tested on the VITEK MS (predicate device) during previous clinical or internal studies. Testing was conducted at two testing sites (internal Biomeriaux sites), with one instrument used at one internal testing site and two other instruments used at a second internal testing site. The study was conducted in two parts 1) Challenge Testing and 2) Clinical Isolate Testing. Repeat testing was conducted according to VITEK MS PRIME User Manual instructions (e.g., for initial No ID, Low Discrimination results, or poor spectra quality). ## Clinical Study, Challenge Testing: The VITEK MS PRIME challenge set consisted of 100 well-characterized species (clinical isolates) selected from challenge organisms, including less common and rare species, that were evaluated in previous VITEK MS clinical studies. Challenge isolates were tested once each with the VITEK MS PRIME system. All organism identities were blinded to the operator, and testing was conducted across three instruments at two testing sites. The performance observed in the study was 94.0% (94/100) correct single choice ID. The other K212461 - Page 19 of 29 {19} 6/100 strains generated results of low discrimination to the correct genus. Results from Challenge testing are summarized by organism group in Table 6 and stratified by species in Table 7. Table 8 includes a summary of repeat testing that was conducted (e.g., for initial No ID results) Table 6: Clinical Study, Challenge Testing Results | VITEK MS IDENTIFICATION | | | | | | | | --- | --- | --- | --- | --- | --- | --- | | Organism Classification | | N | Number of Unique Isolates | Total Correct GENUS ID (One Choice and Low Discrim.) | One Choice Correct: Genus ID Correct: Species ID or Group/Complex ID | Low Discrimination Correct: Genus ID | | Gram + Bacteria | Aerobic | 16 | 16 | 100.0% (16/16) | 93.8% (15/16) | 6.3% (1/16) | | | Anaerobic | 8 | 8 | 100.0% (8/8) | 100.0% (8/8) | 0.0% (0/8) | | | Total | 24 | 24 | 100.0% (24/24) | 95.8% (23/24) | 4.2% (1/24) | | Gram - Bacteria | Aerobic | 34 | 34 | 100.0% (34/34) | 85.3% (29/34) | 14.7% (5/34) | | | Anaerobic | 2 | 2 | 100.0% (2/2) | 100.0% (2/2) | 0.0% (0/2) | | | Total | 36 | 36 | 100.0% (36/36) | 86.1% (31/36) | 13.9% (5/36) | | Yeasts | Total | 12 | 12 | 100.0% (12/12) | 100.0% (12/12) | 0.0% (0/12) | | Moulds | Total | 12 | 12 | 100.0% (12/12) | 100.0% (12/12) | 0.0% (0/12) | | Myco/Nocardia | Mycobacteria | 8 | 8 | 100.0% (8/8) | 100.0% (8/8) | 0.0% (0/8) | | | Nocardia | 8 | 8 | 100.0% (8/8) | 100.0% (8/8) | 0.0% (0/8) | | | Total | 16 | 16 | 100.0% (16/16) | 100.0% (16/16) | 0.0% (0/16) | | ~All~ | Total | 100 | 100 | 100.0% (100/100) | 94.0% (94/100) | 6.0% (6/100) | Table 7: Clinical Study, Challenge Testing, Results By Species | VITEK MS Result | Ref/Gold Std | Interpretation | | --- | --- | --- | | Staphylococcus xylosus | Staphylococcus xylosus | Correct One Choice | | Streptococcus intermedius | Streptococcus intermedius | Correct One Choice | | Streptococcus sobrinus | Streptococcus sobrinus | Correct One Choice | | Cedecea davisae | Cedecea davisae | Correct One Choice | | Chryseobacterium gleum | Chryseobacterium gleum | Correct One Choice | | Cedecea lapagei | Cedecea lapagei | Correct One Choice | | Burkholderia gladioli | Burkholderia gladioli | Correct One Choice | K212461 - Page 20 of 29 {20} K212461 - Page 21 of 29 | Elizabethkingia meningoseptica | Elizabethkingia meningoseptica | Correct One Choice | | --- | --- | --- | | Kluyvera intermedia | Kluyvera intermedia | Correct One Choice | | Providencia alcalifaciens | Providencia alcalifaciens | Correct One Choice | | Yersinia frederiksenii | Yersinia frederiksenii | Correct One Choice | | Leclercia adecarboxylata | Leclercia adecarboxylata | Correct One Choice | | Serratia plymuthica | Serratia plymuthica | Correct One Choice | | Acinetobacter junii | Acinetobacter junii | Correct One Choice | | Pseudomonas luteola | Pseudomonas luteola | Correct One Choice | | Pseudomonas mendocina | Pseudomonas mendocina | Correct One Choice | | Delftia acidovorans | Delftia acidovorans | Correct One Choice | | Ochrobactrum anthropi | Ochrobactrum anthropi | Correct One Choice | | Sphingomonas paucimobilis | Sphingomonas paucimobilis | Correct One Choice | | **Yersinia kristensenii; Yersinia enterocolitica** | **Yersinia kristensenii** | **Low Discrim, Correct Genus** | | Yersinia pseudotuberculosis; Yersinia similis | Yersinia pseudotuberculosis | Low Discrim, Correct Genus | | Acinetobacter haemolyticus | Acinetobacter haemolyticus | Correct One Choice | | Alcaligenes faecalis ssp faecalis | Alcaligenes faecalis ssp faecalis | Correct One Choice | | Bordetella bronchiseptica | Bordetella bronchiseptica | Correct One Choice | | Citrobacter amalonaticus | Citrobacter amalonaticus | Correct One Choice | | Citrobacter farmeri | Citrobacter farmeri | Correct One Choice | | Citrobacter youngae | Citrobacter youngae | Correct One Choice | | **Enterobacter asburiae; Enterobacter cloacae** | **Enterobacter asburiae** | **Low Discrim, Correct Genus** | | Pluralibacter gergoviae | Pluralibacter gergoviae | Correct One Choice | | Escherichia hermannii | Escherichia hermannii | Correct One Choice | | Pantoea agglomerans | Pantoea agglomerans | Correct One Choice | | Pasteurella aerogenes | Pasteurella aerogenes | Correct One Choice | | Pseudomonas putida | Pseudomonas putida | Correct One Choice | | Ralstonia pickettii | Ralstonia pickettii | Correct One Choice | | **Raoultella ornithinolytica; Raoultella planticola** | **Raoultella planticola** | **Low Discrim, Correct Genus** | | **Aeromonas sobria; Aeromonas veronii; Aeromonas salmonicida/bestiarum** | **Aeromonas sobria** | **Low Discrim, Correct Genus** | | Lactococcus lactis | Lactococcus lactis ssp lactis | Correct One Choice | | Aerococcus viridans | Aerococcus viridans | Correct One Choice | | Streptococcus parasanguinis | Streptococcus parasanguinis | Correct One Choice | | Streptococcus uberis | Streptococcus uberis | Correct One Choice | | Nocardia abscessus | Nocardia abscessus | Correct One Choice | | Nocardia asteroides | Nocardia asteroides | Correct One Choice | | Nocardia paucivorans | Nocardia paucivorans | Correct One Choice | | Nocardia pseudobrasiliensis | Nocardia pseudobrasiliensis | Correct One Choice | | Nocardia transvalensis | Nocardia transvalensis | Correct One Choice | | Nocardia wallacei | Nocardia wallacei | Correct One Choice | {21} K212461 - Page 22 of 29 | Nocardia otitidiscaviarum | Nocardia otitidiscaviarum | Correct One Choice | | --- | --- | --- | | Candida rugosa | Candida rugosa | Correct One Choice | | Trichosporon inkin | Trichosporon inkin | Correct One Choice | | Malassezia pachydermatis | Malassezia pachydermatis | Correct One Choice | | Candida zeylanoides | Candida zeylanoides | Correct One Choice | | Candida intermedia | Candida intermedia | Correct One Choice | | Candida lipolytica | Candida lipolytica | Correct One Choice | | Penicillium chrysogenum | Penicillium chrysogenum | Correct One Choice | | Candida famata | Candida famata | Correct One Choice | | Candida lambica | Candida lambica | Correct One Choice | | Candida norvegensis | Candida norvegensis | Correct One Choice | | Candida utilis | Candida utilis | Correct One Choice | | Kodamaea ohmeri | Kodamaea ohmeri | Correct One Choice | | Trichosporon dermatis/mucoides | Trichosporon mucoides | Correct One Choice | | Peptostreptococcus anaerobius | Peptostreptococcus anaerobius | Correct One Choice | | Paraclostridium bifermentans | Paraclostridium bifermentans | Correct One Choice | | Bacteroides uniformis | Bacteroides uniformis | Correct One Choice | | Fusobacterium necrophorum | Fusobacterium necrophorum | Correct One Choice | | Hathewaya histolytica | Hathewaya histolytica | Correct One Choice | | Clostridium ramosum | Clostridium ramosum | Correct One Choice | | Clostridium cadaveris | Clostridium cadaveris | Correct One Choice | | Clostridium tertium | Clostridium tertium | Correct One Choice | | Parvimonas micra | Parvimonas micra | Correct One Choice | | Clostridium baratii | Clostridium baratii | Correct One Choice | | Mycobacterium simiae | Mycobacterium simiae | Correct One Choice | | Pseudallescheria boydii | Pseudallescheria boydii | Correct One Choice | | Alternaria alternata | Alternaria alternata | Correct One Choice | | Aspergillus sydowii | Aspergillus sydowii | Correct One Choice | | Exophiala xenobiotica | Exophiala xenobiotica | Correct One Choice | | Lecythophora hoffmannii | Lecythophora hoffmannii | Correct One Choice | | Purpureocillium lilacinum | Purpureocillium lilacinum | Correct One Choice | | Scedosporium prolificans | Scedosporium prolificans | Correct One Choice | | Lichtheimia corymbifera | Lichtheimia corymbifera | Correct One Choice | | Aspergillus calidoustus/ustus | Aspergillus calidoustus | Correct One Choice | | Aspergillus lentulus | Aspergillus lentulus | Correct One Choice | | Mycobacterium chelonae | Mycobacterium chelonae | Correct One Choice | | Mycobacterium immunogenum | Mycobacterium immunogenum | Correct One Choice | | Mycobacterium marinum | Mycobacterium marinum | Correct One Choice | | Mycobacterium mucogenicum | Mycobacterium mucogenicum | Correct One Choice | | Mycobacterium scrofulaceum | Mycobacterium scrofulaceum | Correct One Choice | | Mycobacterium smegmatis | Mycobacterium smegmatis | Correct One Choice | | Citrobacter braakii | Citrobacter braakii | Correct One Choice | | Aspergillus nidulans | Aspergillus nidulans | Correct One Choice | | Nocardia veterana | Nocardia veterana | Correct One Choice | | Mycobacterium malmoense | Mycobacterium malmoense | Correct One Choice | {22} K212461 - Page 23 of 29 | Staphylococcus lentus | Staphylococcus lentus | Correct One Choice | | --- | --- | --- | | Staphylococcus sciuri | Staphylococcus sciuri | Correct One Choice | | Staphylococcus hyicus | Staphylococcus hyicus | Correct One Choice | | Staphylococcus schleiferi | Staphylococcus schleiferi | Correct One Choice | | Staphylococcus auricularis | Staphylococcus auricularis | Correct One Choice | | Staphylococcus cohnii ssp cohnii | Staphylococcus cohnii ssp cohnii | Correct One Choice | | Staphylococcus chromogenes | Staphylococcus chromogenes | Correct One Choice | | Enterococcus hirae | Enterococcus hirae | Correct One Choice | | Staphylococcus intermedius; Staphylococcus pseudintermedius | Staphylococcus pseudintermedius | Low Discrim, Correct Genus | Table 8: Challenge Testing, Repeat Rate | Organism Classification | | N | Spot Repeat (Percent) | | --- | --- | --- | --- | | Gram+ Bacteria | Aerobic | 16 | 0 (0.0%) | | | Anaerobic | 8 | 0 (0.0%) | | Gram- Bacteria | Aerobic | 34 | 0 (0.0%) | | | Anaerobic | 2 | 0 (0.0%) | | Yeasts | Aerobic | 12 | 1 (8.3%) | | Moulds | Moulds | 12 | 1 (8.3%) | | Myco/Nocardia | Mycobacteria | 8 | 1 (12.5%) | | | Nocardia | 8 | 0 (0.0%) | | ~All~ | Grand Total | 100 | 3 (3.0%) | ## Clinical Study, Clinical Isolates (Different species than were included in Challenge testing) The organisms selected for the second portion of the clinical study were well-characterized strains previously tested on the VITEK MS system at clinical trial sites and/or during internal studies. The organism set included up to five strains for each of 100 common and/or clinically relevant species/groups/complexes from all organism groups combined. Testing was conducted using three instrument systems at two internal testing sites (one instrument used at one internal testing site and two instruments used at the second internal testing site). Of the 500 isolates tested in the study, 491 were unique clinical isolates and nine were clones of clinical isolates. The numbers of species and strains evaluated for each organism group are presented in Table 9. Table 9: Organism Groups: Numbers of Species and Strains Tested | Organism Group | # of Species | # of Strains/Organism Group | | --- | --- | --- | | Aerobic Gram Positive Bacteria | 25 | 125 | | Anaerobic Gram Positive Bacteria | 4 | 20 | | Aerobic Gram Negative Bacteria | 27 | 135 | | Anaerobic Gram Negative Bacteria | 5 | 25 | | Mycobacterium | 8 | 40 | | Nocardia | 4 | 20 | | Moulds | 10 | 50 | | Yeasts | 17 | 85 | | Total | 100 | 500 | {23} VITEK MS PRIME identification results were compared to the reference identification result and the rate of correct identification and corresponding exact $95\%$ confidence interval was calculated for each of the organisms tested, as well as overall. The study demonstrated $98.4\%$ (492/500) agreement, $95\%$ CI $[96.8\%, 99.3\%]$ , for all clinical bacteria, moulds, and yeast isolates tested (correct single choice ID or low discrimination correct genus) from all sites combined, with 2 $(0.4\%)$ misidentifications and 6 $(1.2\%)$ No ID results. Results by organism group are presented in Table 10. Results stratified by species are presented in Table 11. Table 10: Clinical Study, Performance by Organism Group | | | | VITEK MS IDENTIFICATION | | | | | | | | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | | Organism Classification | | Unique Isolates | Total Correct GENUS ID (One Choice and Low Discrim.) | One Choice Correct: Genus ID Correct: Species ID or Group/Complex ID | | Low Discrimination Correct: Genus ID | | Discord ant ID | No ID | | | | | | One choice reference result | Multiple choice reference result1 | One choice reference result | Multiple choice reference result1 | | | | Gram + Bacteria | Aero | 125 | 99.2% (124/125) | 92.0% (115/125) | 0.0% (0/125) | 7.2% (9/125) | 0.0% (0/125) | 0.8% (1/125) | 0.0% (0/125) | | | Anaero | 20 | 100.0% (20/20) | 100.0% (20/20) | 0.0% (0/20) | 0.0% (0/20) | 0.0% (0/20) | 0.0% (0/20) | 0.0% (0/20) | | | Total | 145 | 99.3% (144/145) | 93.1% (135/145) | 0.0% (0/145) | 6.2% (9/145) | 0.0% (0/145) | 0.7% (1/145) | 0.0% (0/145) | | Gram - Bacteria | Aero | 135 | 98.5% (133/135) | 94.8% (128/135) | 0.0% (0/135) | 3.7% (5/135) | 0.0% (0/135) | 0.0% (0/135) | 1.5% (2/135) | | | Anaero | 25 | 100.0% (25/25) | 100.0% (25/25) | 0.0% (0/25) | 0.0% (0/25) | 0.0% (0/25) | 0.0% (0/25) | 0.0% (0/25) | | | Total | 160 | 98.8% (158/160) | 95.6% (153/160) | 0.0% (0/160) | 3.1% (5/160) | 0.0% (0/160) | 0.0% (0/160) | 1.3% (2/160) | | Yeasts | Total | 85 | 95.3% (81/85) | 95.3% (81/85) | 0.0% (0/85) | 0.0% (0/85) | 0.0% (0/85) | 0.0% (0/85) | 4.7% (4/85) | | Moulds | Total | 42 | 98.0% (49/50) | 76.0% (38/50) | 20.0% (10/50) | 2.0% (1/50) | 0.0% (0/50) | 2.0% (1/50) | 0.0% (0/50) | | Myco/Nocardia | Mycobacteria | 39 | 100.0% (40/40) | 100.0% (40/40) | 0.0% (0/40) | 0.0% (0/40) | 0.0% (0/40) | 0.0% (0/40) | 0.0% (0/40) | | | Nocardia | 20 | 100.0% (20/20) | 100.0% (20/20) | 0.0% (0/20) | 0.0% (0/20) | 0.0% (0/20) | 0.0% (0/20) | 0.0% (0/20) | | | Total | 59 | 100.0% (60/60) | 100.0% (60/60) | 0.0% (0/60) | 0.0% (0/60) | 0.0% (0/60) | 0.0% (0/60) | 0.0% (0/60) | | ~All~ | Grand Total | 491 | 98.4% (492/500) | 93.4% (467/500) | 2.0% (10/500) | 3.0% (15/500) | 0.0% (0/500) | 0.4% (2/500) | 1.2% (6/500) | 1 Multiple choice reference result indicates when the reference identification method identifies the genus but does not distinguish between two or more species. VITEK MS PRIME results for 10 mould isolates were concordant with one of the species included in the multiple-choice reference ID. K212461 - Page 24 of 29 {24} Table 11: Clinical Study, Performance By Species | Species | N | # Unique Strains | Total Correct GENUS ID (One Choice and Low Discrim.) | One Choice Correct: Genus ID Correct: Species ID or Group/Complex ID | | Low Discrimination Correct: Genus ID | | Discordant ID | No ID | | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | | | | | | One choice reference result | Multiple choice reference result1 | One choice reference result | Multiple choice reference result1 | | | | Clostridium difficile | 5 | 5 | 100.0% (5/5) | 100.0% (5/5) | 0.0% (0/5) | 0.0% (0/5) | 0.0% (0/5) | 0.0% (0/5) | 0.0% (0/5) | | Clostridium perfringens | 5 | 5 | 100.0% (5/5) | 100.0% (5/5) | 0.0% (0/5) | 0.0% (0/5) | 0.0% (0/5) | 0.0% (0/5) | 0.0% (0/5) | | Clostridium septicum | 5 | 5 | 100.0% (5/5) | 100.0% (5/5) | 0.0% (0/5) | 0.0% (0/5) | 0.0% (0/5) | 0.0% (0/5) | 0.0% (0/5) | | Enterococcus avium | 5 | 5 | 100.0% (5/5) | 100.0% (5/5) | 0.0% (0/5) | 0.0% (0/5) | 0.0% (0/5) | 0.0% (0/5) | 0.0% (0/5) | | Enterococcus casseliflavus | 5 | 5 | 100.0% (5/5) | 100.0% (5/5) | 0.0% (0/5) | 0.0% (0/5) | 0.0% (0/5) | 0.0% (0/5) | 0.0% (0/5) | | Enterococcus durans | 5 | 5 | 100.0% (5/5) | 100.0% (5/5) | 0.0% (0/5) | 0.0% (0/5) | 0.0% (0/5) | 0.0% (0/5) | 0.0% (0/5) | | Enterococcus faecalis | 5 | 5 | 100.0% (5/5) | 100.0% (5/5) | 0.0% (0/5) | 0.0% (0/5) | 0.0% (0/5) | 0.0% (0/5) | 0.0% (0/5) | | Enterococcus faecium | 5 | 5 | 100.0% (5/5) | 100.0% (5/5) | 0.0% (0/5) | 0.0% (0/5) | 0.0% (0/5) | 0.0% (0/5) | 0.0% (0/5) | | Enterococcus gallinarum | 5 | 5 | 100.0% (5/5) | 100.0% (5/5) | 0.0% (0/5) | 0.0% (0/5) | 0.0% (0/5) | 0.0% (0/5) | 0.0% (0/5) | | Listeria monocytogenes | 5 | 5 | 80.0% (4/5) | 60.0% (3/5) | 0.0% (0/5) | 20.0% (1/5) | 0.0% (0/5) | 20.0% (1/5) | 0.0% (0/5) | | Micrococcus luteus | 5 | 5 | 100.0% (5/5) | 100.0% (5/5) | 0.0% (0/5) | 0.0% (0/5) | 0.0% (0/5) | 0.0% (0/5) | 0.0% (0/5) | | Propionibacterium acnes | 5 | 5 | 100.0% (5/5) | 100.0% (5/5) | 0.0% (0/5) | 0.0% (0/5) | 0.0% (0/5) | 0.0% (0/5) | 0.0% (0/5) | | Staphylococcus aureus | 5 | 5 | 100.0% (5/5) | 100.0% (5/5) | 0.0% (0/5) | 0.0% (0/5) | 0.0% (0/5) | 0.0% (0/5) | 0.0% (0/5) | | Staphylococcus capitis | 5 | 5 | 100.0% (5/5) | 100.0% (5/5) | 0.0% (0/5) | 0.0% (0/5) | 0.0% (0/5) | 0.0% (0/5) | 0.0% (0/5) | | Staphylococcus epidermidis | 5 | 5 | 100.0% (5/5) | 100.0% (5/5) | 0.0% (0/5) | 0.0% (0/5) | 0.0% (0/5) | 0.0% (0/5) | 0.0% (0/5) | | Staphylococcus haemolyticus | 5 | 5 | 100.0% (5/5) | 100.0% (5/5) | 0.0% (0/5) | 0.0% (0/5) | 0.0% (0/5) | 0.0% (0/5) | 0.0% (0/5) | | Staphylococcus hominis ssp hominis | 5 | 5 | 100.0% (5/5) | 100.0% (5/5) | 0.0% (0/5) | 0.0% (0/5) | 0.0% (0/5) | 0.0% (0/5) | 0.0% (0/5) | | Staphylococcus lugdunensis | 5 | 5 | 100.0% (5/5) | 100.0% (5/5) | 0.0% (0/5) | 0.0% (0/5) | 0.0% (0/5) | 0.0% (0/5) | 0.0% (0/5) | | Staphylococcus saprophyticus | 5 | 5 | 100.0% (5/5) | 100.0% (5/5) | 0.0% (0/5) | 0.0% (0/5) | 0.0% (0/5) | 0.0% (0/5) | 0.0% (0/5) | | Staphylococcus simulans | 5 | 5 | 100.0% (5/5) | 100.0% (5/5) | 0.0% (0/5) | 0.0% (0/5) | 0.0% (0/5) | 0.0% (0/5) | 0.0% (0/5) | | Staphylococcus warneri | 5 | 5 | 100.0% (5/5) | 80.0% (4/5) | 0.0% (0/5) | 20.0% (1/5) | 0.0% (0/5) | 0.0% (0/5) | 0.0% (0/5) | | Streptococcus agalactiae | 5 | 5 | 100.0% (5/5) | 100.0% (5/5) | 0.0% (0/5) | 0.0% (0/5) | 0.0% (0/5) | 0.0% (0/5) | 0.0% (0/5) | | Streptococcus anginosus | 5 | 5 | 100.0% (5/5) | 60.0% (3/5) | 0.0% (0/5) | 40.0% (2/5) | 0.0% (0/5) | 0.0% (0/5) | 0.0% (0/5) | | Streptococcus constellatus | 5 | 5 | 100.0% (5/5) | 100.0% (5/5) | 0.0% (0/5) | 0.0% (0/5) | 0.0% (0/5) | 0.0% (0/5) | 0.0% (0/5) | | Streptococcus dysgalactiae ssp dysgalactiae | 1 | 1 | 100.0% (1/1) | 0.0% (0/1) | 0.0% (0/1) | 100.0% (1/1) | 0.0% (0/1) | 0.0% (0/1) | 0.0% (0/1) | K212461 - Page 25 of 29 {25} K212461 - Page 26 of 29 | Streptococcus dysgalactiae ssp equisimilis | 4 | 4 | 100.0% (4/4) | 0.0% (0/4) | 0.0% (0/4) | 100.0% (4/4) | 0.0% (0/4) | 0.0% (0/4) | 0.0% (0/4) | | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | | Streptococcus mitis | 1 | 1 | 100.0% (1/1) | 100.0% (1/1) | 0.0% (0/1) | 0.0% (0/1) | 0.0% (0/1) | 0.0% (0/1) | 0.0% (0/1) | | Streptococcus oralis | 4 | 4 | 100.0% (4/4) | 100.0% (4/4) | 0.0% (0/4) | 0.0% (0/4) | 0.0% (0/4) | 0.0% (0/4) | 0.0% (0/4) | | Streptococcus pneumoniae | 5 | 5 | 100.0% (5/5) | 100.0% (5/5) | 0.0% (0/5) | 0.0% (0/5) | 0.0% (0/5) | 0.0% (0/5) | 0.0% (0/5) | | Streptococcus pyogenes | 5 | 5 | 100.0% (5/5) | 100.0% (5/5) | 0.0% (0/5) | 0.0% (0/5) | 0.0% (0/5) | 0.0% (0/5) | 0.0% (0/5) | | Streptococcus sanguinis | 5 | 5 | 100.0% (5/5) | 100.0% (5/5) | 0.0% (0/5) | 0.0% (0/5) | 0.0% (0/5) | 0.0% (0/5) | 0.0% (0/5) | | Acinetobacter baumannii | 5 | 5 | 100.0% (5/5) | 100.0% (5/5) | 0.0% (0/5) | 0.0% (0/5) | 0.0% (0/5) | 0.0% (0/5) | 0.0% (0/5) | | Acinetobacter lwoffii | 5 | 5 | 100.0% (5/5) | 100.0% (5/5) | 0.0% (0/5) | 0.0% (0/5) | 0.0% (0/5) | 0.0% (0/5) | 0.0% (0/5) | | Aeromonas hydrophila | 5 | 5 | 100.0% (5/5) | 80.0% (4/5) | 0.0% (0/5) | 20.0% (1/5) | 0.0% (0/5) | 0.0% (0/5) | 0.0% (0/5) | | Bacteroides fragilis | 5 | 5 | 100.0% (5/5) | 100.0% (5/5) | 0.0% (0/5) | 0.0% (0/5) | 0.0% (0/5) | 0.0% (0/5) | 0.0% (0/5) | | Bacteroides ovatus | 5 | 5 | 100.0% (5/5) | 100.0% (5/5) | 0.0% (0/5) | 0.0% (0/5) | 0.0% (0/5) | 0.0% (0/5) | 0.0% (0/5) | | Bacteroides thetaiotaomicron | 5 | 5 | 100.0% (5/5) | 100.0% (5/5) | 0.0% (0/5) | 0.0% (0/5) | 0.0% (0/5) | 0.0% (0/5) | 0.0% (0/5) | | Bacteroides vulgatus | 5 | 5 | 100.0% (5/5) | 100.0% (5/5) | 0.0% (0/5) | 0.0% (0/5) | 0.0% (0/5) | 0.0% (0/5) | 0.0% (0/5) | | Burkholderia cenocepacia | 5 | 5 | 100.0% (5/5) | 100.0% (5/5) | 0.0% (0/5) | 0.0% (0/5) | 0.0% (0/5) | 0.0% (0/5) | 0.0% (0/5) | | Burkholderia multivorans | 5 | 5 | 100.0% (5/5) | 100.0% (5/5) | 0.0% (0/5) | 0.0% (0/5) | 0.0% (0/5) | 0.0% (0/5) | 0.0% (0/5) | | Campylobacter jejuni | 5 | 5 | 100.0% (5/5) | 100.0% (5/5) | 0.0% (0/5) | 0.0% (0/5) | 0.0% (0/5) | 0.0% (0/5) | 0.0% (0/5) | | Citrobacter freundii | 5 | 5 | 100.0% (5/5) | 100.0% (5/5) | 0.0% (0/5) | 0.0% (0/5) | 0.0% (0/5) | 0.0% (0/5) | 0.0% (0/5) | | Citrobacter koseri | 5 | 5 | 100.0% (5/5) | 100.0% (5/5) | 0.0% (0/5) | 0.0% (0/5) | 0.0% (0/5) | 0.0% (0/5) | 0.0% (0/5) | | Elizabet hkingia anophelis | 5 | 5 | 100.0% (5/5) | 100.0% (5/5) | 0.0% (0/5) | 0.0% (0/5) | 0.0% (0/5) | 0.0% (0/5) | 0.0% (0/5) | | Enterobacter aerogenes | 5 | 5 | 100.0% (5/5) | 100.0% (5/5) | 0.0% (0/5) | 0.0% (0/5) | 0.0% (0/5) | 0.0% (0/5) | 0.0% (0/5) | | Enterobacter cloacae | 5 | 5 | 60.0% (3/5) | 0.0% (0/5) | 0.0% (0/5) | 60.0% (3/5) | 0.0% (0/5) | 0.0% (0/5) | 40.0% (2/5) | | Escherichia coli | 5 | 5 | 100.0% (5/5) | 100.0% (5/5) | 0.0% (0/5) | 0.0% (0/5) | 0.0% (0/5) | 0.0% (0/5) | 0.0% (0/5) | | Haemophilus influenzae | 5 | 5 | 100.0% (5/5) | 100.0% (5/5) | 0.0% (0/5) | 0.0% (0/5) | 0.0% (0/5) | 0.0% (0/5) | 0.0% (0/5) | | Haemophilus parainfluenzae | 5 | 5 | 100.0% (5/5) | 100.0% (5/5) | 0.0% (0/5) | 0.0% (0/5) | 0.0% (0/5) | 0.0% (0/5) | 0.0% (0/5) | | Klebsiella oxytoca | 5 | 5 | 100.0% (5/5) | 100.0% (5/5) | 0.0% (0/5) | 0.0% (0/5) | 0.0% (0/5) | 0.0% (0/5) | 0.0% (0/5) | | Klebsiella pneumoniae | 5 | 5 | 100.0% (5/5) | 100.0% (5/5) | 0.0% (0/5) | 0.0% (0/5) | 0.0% (0/5) | 0.0% (0/5) | 0.0% (0/5) | | Legionella pneumophila | 5 | 5 | 100.0% (5/5) | 100.0% (5/5) | 0.0% (0/5) | 0.0% (0/5) | 0.0% (0/5) | 0.0% (0/5) | 0.0% (0/5) | | Moraxella (Branhamella) catarrhalis | 5 | 5 | 100.0% (5/5) | 100.0% (5/5) | 0.0% (0/5) | 0.0% (0/5) | 0.0% (0/5) | 0.0% (0/5) | 0.0% (0/5) | | Morganella morganii | 5 | 5 | 100.0% (5/5) | 100.0% (5/5) | 0.0% (0/5) | 0.0% (0/5) | 0.0% (0/5) | 0.0% (0/5) | 0.0% (0/5) | | Neisseria gonorrhoeae | 5 | 5 | 100.0% (5/5) | 100.0% (5/5) | 0.0% (0/5) | 0.0% (0/5) | 0.0% (0/5) | 0.0% (0/5) | 0.0% (0/5) | {26} K212461 - Page 27 of 29 | Prevotella bivia | 5 | 5 | 100.0% (5/5) | 100.0% (5/5) | 0.0% (0/5) | 0.0% (0/5) | 0.0% (0/5) | 0.0% (0/5) | | --- | --- | --- | --- | --- | --- | --- | --- | --- | | Proteus mirabilis | 5 | 5 | 100.0% (5/5) | 100.0% (5/5) | 0.0% (0/5) | 0.0% (0/5) | 0.0% (0/5) | 0.0% (0/5) | | Providencia rettgeri | 5 | 5 | 100.0% (5/5) | 80.0% (4/5) | 0.0% (0/5) | 20.0% (1/5) | 0.0% (0/5) | 0.0% (0/5) | | Providencia stuartii | 5 | 5 | 100.0% (5/5) | 100.0% (5/5) | 0.0% (0/5) | 0.0% (0/5) | 0.0% (0/5) | 0.0% (0/5) | | Pseudomonas aeruginosa | 5 | 5 | 100.0% (5/5) | 100.0% (5/5) | 0.0% (0/5) | 0.0% (0/5) | 0.0% (0/5) | 0.0% (0/5) | | Serratia marcescens | 5 | 5 | 100.0% (5/5) | 100.0% (5/5) | 0.0% (0/5) | 0.0% (0/5) | 0.0% (0/5) | 0.0% (0/5) | | Serratia odorifera | 5 | 5 | 100.0% (5/5) | 100.0% (5/5) | 0.0% (0/5) | 0.0% (0/5) | 0.0% (0/5) | 0.0% (0/5) | | Stenotrophomonas maltophilia | 5 | 5 | 100.0% (5/5) | 100.0% (5/5) | 0.0% (0/5) | 0.0% (0/5) | 0.0% (0/5) | 0.0% (0/5) | | Candida albicans | 5 | 5 | 100.0% (5/5) | 100.0% (5/5) | 0.0% (0/5) | 0.0% (0/5) | 0.0% (0/5) | 0.0% (0/5) | | Candida auris | 5 | 5 | 100.0% (5/5) | 100.0% (5/5) | 0.0% (0/5) | 0.0% (0/5) | 0.0% (0/5) | 0.0% (0/5) | | Candida dubliniensis | 5 | 5 | 100.0% (5/5) | 100.0% (5/5) | 0.0% (0/5) | 0.0% (0/5) | 0.0% (0/5) | 0.0% (0/5) | | Candida glabrata | 5 | 5 | 100.0% (5/5) | 100.0% (5/5) | 0.0% (0/5) | 0.0% (0/5) | 0.0% (0/5) | 0.0% (0/5) | | Candida guilliermondii | 5 | 5 | 80.0% (4/5) | 80.0% (4/5) | 0.0% (0/5) | 0.0% (0/5) | 0.0% (0/5) | 20.0% (1/5) | | Candida inconspicua | 5 | 5 | 100.0% (5/5) | 100.0% (5/5) | 0.0% (0/5) | 0.0% (0/5) | 0.0% (0/5) | 0.0% (0/5) | | Candida kefyr | 5 | 5 | 100.0% (5/5) | 100.0% (5/5) | 0.0% (0/5) | 0.0% (0/5) | 0.0% (0/5) | 0.0% (0/5) | | Candida krusei | 5 | 5 | 100.0% (5/5) | 100.0% (5/5) | 0.0% (0/5) | 0.0% (0/5) | 0.0% (0/5) | 0.0% (0/5) | | Candida lusitaniae | 5 | 5 | 40.0% (2/5) | 40.0% (2/5) | 0.0% (0/5) | 0.0% (0/5) | 0.0% (0/5) | 60.0% (3/5) | | Candida parapsilosis | 5 | 5 | 100.0% (5/5) | 100.0% (5/5) | 0.0% (0/5) | 0.0% (0/5) | 0.0% (0/5) | 0.0% (0/5) | | Candida pelliculosa | 5 | 5 | 100.0% (5/5) | 100.0% (5/5) | 0.0% (0/5) | 0.0% (0/5) | 0.0% (0/5) | 0.0% (0/5) | | Candida tropicalis | 5 | 5 | 100.0% (5/5) | 100.0% (5/5) | 0.0% (0/5) | 0.0% (0/5) | 0.0% (0/5) | 0.0% (0/5) | | Cryptococcus neoformans | 5 | 5 | 100.0% (5/5) | 100.0% (5/5) | 0.0% (0/5) | 0.0% (0/5) | 0.0% (0/5) | 0.0% (0/5) | | Rhodotorula mucilaginosa | 5 | 5 | 100.0% (5/5) | 100.0% (5/5) | 0.0% (0/5) | 0.0% (0/5) | 0.0% (0/5) | 0.0% (0/5) | | Saccharomyces cerevisiae | 5 | 5 | 100.0% (5/5) | 100.0% (5/5) | 0.0% (0/5) | 0.0% (0/5) | 0.0% (0/5) | 0.0% (0/5) | | Saprochaete capitata | 5 | 5 | 100.0% (5/5) | 100.0% (5/5) | 0.0% (0/5) | 0.0% (0/5) | 0.0% (0/5) | 0.0% (0/5) | | Trichosporon asahii | 5 | 5 | 100.0% (5/5) | 100.0% (5/5) | 0.0% (0/5) | 0.0% (0/5) | 0.0% (0/5) | 0.0% (0/5) | | Aspergillus flavus/oryzae | 5 | 5 | 100.0% (5/5) | 0.0% (0/5) | 100.0% (5/5) | 0.0% (0/5) | 0.0% (0/5) | 0.0% (0/5) | | Aspergillus fumigatus | 5 | 5 | 100.0% (5/5) | 100.0% (5/5) | 0.0% (0/5) | 0.0% (0/5) | 0.0% (0/5) | 0.0% (0/5) | | Aspergillus niger complex | 5 | 5 | 100.0% (5/5) | 100.0% (5/5) | 0.0% (0/5) | 0.0% (0/5) | 0.0% (0/5) | 0.0% (0/5) | | Aspergillus terreus complex | 5 | 5 | 100.0% (5/5) | 100.0% (5/5) | 0.0% (0/5) | 0.0% (0/5) | 0.0% (0/5) | 0.0% (0/5) | | Blastomyces dermatitidis | 5 | 3 | 100.0% (5/5) | 100.0% (5/5) | 0.0% (0/5) | 0.0% (0/5) | 0.0% (0/5) | 0.0% (0/5) | | Coccidioides immitis/posadasii | 5 | 4 | 100.0% (5/5) | 0.0% (0/5) | 100.0% (5/5) | 0.0% (0/5) | 0.0% (0/5) | 0.0% (0/5) | {27} Table 12 includes a summary of repeat testing that was conducted during the Clinical Study: Table 12: Clinical Study Isolates, Summary of repeat testing | Organism Classification | | N | Spot Repeat (Percent) | New Extract (Percent) | | --- | --- | --- | --- | --- | | Gram+ Bacteria | Aerobic | 125 | 3 (2.4%) | 0 (0.0%) | | | Anaerobic | 20 | 0 (0.0%) | 0 (0.0%) | | Gram- Bacteria | Aerobic | 135 | 7 (5.2%) | 0 (0.0%) | | | Anaerobic | 25 | 3 (12.0%) | 0 (0.0%) | | Yeasts | Aerobic | 85 | 6 (7.1%) | 0 (0.0%) | | Moulds | Moulds | 50 | 3 (6.0%) | 2 (4.0%) | | Myco/Nocardia | Mycobacteria | 40 | 10 (25.0%) | 4 (10.0%) | | | Nocardia | 20 | 0 (0.0%) | 0 (0.0%) | | ~All~ | Total | 500 | 32 (6.4%) | 6 (1.2%) | D Clinical Cut-Off: Not applicable K212461 - Page 28 of 29 {28} E Expected Values/Reference Range: See K181412 F Other Supportive Instrument Performance Characteristics Data: VIII Proposed Labeling: The labeling supports the finding of substantial equivalence for this device. IX Conclusion: The submitted information in this premarket notification is complete and supports a substantial equivalence decision. K212461 - Page 29 of 29

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