K Number

Device Name

VITEK MS

Manufacturer

bioMerieux, Inc.

Date Cleared

2017-07-22

(271 days)

Product Code

PEX

Regulation Number

866.3361

Intended Use

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 is a qualitative in vitro diagnostic device in conjunction with other clinical and laboratory findings to aid in the diagnosis of bacterial, yeast and mould infections.

Device Description

VITEK® MS is 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 is a qualitative in vitro diagnostic device indicated for use in coniunction with other clinical and laboratory findings to aid in the diagnosis of bacterial, yeast and mould infections. The VITEK® MS is intended for laboratory use by professional users who are trained in microbiology and good laboratory practices. This 510(k) is an update to the VITEK® MS (Mass Spectrometry) clinical knowledge base (KB v3.0.0) for the purposes of identifying Mycobacterium, Nocardia, and mould isolates. As the VITEK® MS KB v3.0.0 update includes new indications for use on the VITEK® MS system, new clinical data was required to establish safety and effectiveness. To account for the detection of higher mass peaks, relevant for some moulds and Mycobacterium, the VITEK® MS acquisition station software was optimized (in v1.5.0) . Microorqanism identifications are are 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. Depending on the isolate culture, the analyte sample may be directly spotted to a target slide, or for Mycobacterium, Nocardia and mould it must be processed/inactivated before adding to the target slide. Once 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 slide is then loaded onto the 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. The ionized molecules are then accelerated in an electromagnetic field and a grid electrode in the ionization chamber. 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. The time of flight 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 mass spectrum displays results as a series of peaks (spectrum) which correspond to the ionized proteins derived from the analyte sample. The mass spectra are sufficiently distinctive to allow taxonomic characterization at the genus and species.

More Information

Contact

Type

Center

Panel

Date Received

Product Code

Subsequent Product Codes

Applicant Name (Manufacturer)

Device Name

Decision

Street 1

Street 2

City

State

Country Code

ZIP

Postal Code

Class Advise Committee

SSP Indicator

Third Party Reviewed

Expedited Review

Predicate Devices

K124067

Reference Devices

DEN130013, K124067

AI/ML (Artificial Intelligence / Machine Learning)

No
The document describes a mass spectrometry system that identifies microorganisms based on mass spectra analysis. While this involves complex data processing and comparison to a knowledge base, there is no explicit mention or description of AI or ML algorithms being used for the identification process or any other function of the device. The identification appears to be based on comparing generated mass spectra to a reference library.

Therapeutic

The VITEK® MS is a diagnostic device used to identify microorganisms for diagnosis, not to treat a condition.

Diagnostic

Yes

The "Intended Use / Indications for Use" section explicitly states that the VITEK® MS is a "qualitative in vitro diagnostic device" used to aid in the diagnosis of various infections.

SaMD (Software as a Medical Device)

The device description explicitly states that VITEK® MS is a "mass spectrometry system" and describes the hardware components and processes involved in MALDI-TOF MS technology (laser, target slide, ionization chamber, particle detector). While the 510(k) is for a software update (clinical knowledge base and acquisition station software optimization), the overall device is a hardware system with integrated software, not a software-only medical device.

IVD (In Vitro Diagnostic)

Yes, this device is an IVD (In Vitro Diagnostic).

The document explicitly states in both the "Intended Use / Indications for Use" and "Device Description" sections that the VITEK® MS is a qualitative in vitro diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The VITEK® MS is a qualitative in vitro diagnostic device in conjunction with other clinical and laboratory findings to aid in the diagnosis of bacterial, yeast and mould infections.

(See Attached for 'List of Claimed Organisms')

Product codes

PEX

Device Description

Microorqanism identifications are are 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. Depending on the isolate culture, the analyte sample may be directly spotted to a target slide, or for Mycobacterium, Nocardia and mould it must be processed/inactivated before adding to the target slide. Once 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 slide is then loaded onto the 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. The ionized molecules are then accelerated in an electromagnetic field and a grid electrode in the ionization chamber. 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.

The time of flight 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 mass spectrum displays results as a series of peaks (spectrum) which correspond to the ionized proteins derived from the analyte sample. The mass spectra are sufficiently distinctive to allow taxonomic characterization at the genus and species.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Not Found

Indicated Patient Age Range

Not Found

Intended User / Care Setting

The VITEK® MS is intended for laboratory use by professional users who are trained in microbiology and good laboratory practices.

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Clinical performance testing for he VITEK® MS v3 / KB v3.0.0 was conducted at five sites, for the purpose of an expanded intended use for Mycobacterium, Nocardia, and moulds. Performance testing included a total of 2.695 Mycobacteria. Nocardia and mould isolates, and evaluation of performance was a comparison of the VITEK MS identification results to molecular sequencing methods (i.e. the reference method). Testing Mycobacteria isolates included samples from both solid and liguid culture media.

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Clinical strains for all isolates tested from solid and liguid media at all sites combined show an acceptable agreement rate of 94.6% (correct single identification plus a low discrimination correct genus result), as well as with each organism group [moulds (92.7%), mycobacteria (96.5%) and Nocardia (97.9%). A combined very low error rate of 0.7% (19/2695) was obtained with all isolates tested, and the combined no identification rate was acceptable at 4.7% (127/2695).

When excluding No ID results, clinical strains for all isolates tested from solid and liguid media at all sites combined show a high agreement rate of 99.3% (correct single choice identification plus a low discrimination correct genus result), as well as high agreement with each organism group [moulds (99.1%), mycobacteria (99.6%) and Nocardia (99.2%)]. A very low error rate of 0.7% (19/2568) was obtained with all isolates combined.

One hundred well-characterized challenge strains included 50 moulds, 35 mycobacteria and 15 Nocardia strains. Three trial sites tested the mould challenge strains, and three trial sites tested the mycobacteria and Nocardia challenge strains. 95.7% (287/300) of Challenge results were correct one choice, and 1.0% (3/300) of results were low discrimination correct genus, for a combined agreement of 96.7% (290/300), for the mould, mycobacteria and Nocardia challenqe isolates tested at all sites combined. No misidentifications were obtained, and no identification was obtained with 10 (3.3%) of all challenge isolates tested at all sites combined.

When excluding the No ID Challenge results, 99.0% (287/290) of results were correct one choice, and 1.0% (3/290) of results were low discrimination correct genus, for a combined agreement of 100% (290/290) for the mould, mycobacteria and Nocardia challenge isolates tested at all clinical trial sites combined.

Quality control strains Mycobacterium smegmatis, ATCC 19420, and Nocardia farcinica, ATCC 3308. showed 100% agreement. the quality control strain Aspergillus brasilienss. ATCC 16404, showed 97.5% agreement, and the negative control showed 99.7% agreement.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

VITEK® MS (DEN130013 / K124067)

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

Regulation Number and Section

§ 866.3361 Mass spectrometer system for clinical use for the identification of microorganisms.

(a)
Identification. 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 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.(b)
Classification. Class II (special controls). The special controls for this device are:(1) Premarket notification submissions must include detailed documentation for device software, including, but not limited to, standalone software applications and hardware-based devices that incorporate software.
(2) Premarket notification submissions must include database implementation methodology, construction parameters, and quality assurance protocols.
(3) A detailed explanation of the interpretation of results and acceptance criteria must be included in the device's 21 CFR 809.10(b)(9) compliant labeling.
(4) As part of the risk management activities performed as part of your 21 CFR 820.30 design controls, you must document an appropriate end user device training program that will be offered as part of your efforts to mitigate the risk of failure to correctly operate the instrument.
(5) Premarket notification submissions must include details on the appropriate end user device training program that will be offered while marketing the device.

Summary

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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

September 25, 2017

BIOMERIEUX, INC. NATHAN HARDESTY MANAGER, REGULATORY AFFAIRS MICROBIOLOGY 595 ANGLUM RD. HAZELWOOD MO 63042

Re: K162950

Trade/Device Name: VITEK MS Regulation Number: 21 CFR 866.3361 Regulation Name: Mass spectrometer system for clinical use for the identification of microorganisms

Regulatory Class: II Product Code: PEX Dated: June 16, 2017 Received: June 19, 2017

Dear Mr. Hardesty:

This letter corrects our substantially equivalent letter of July 22, 2017.

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 (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulations (21 CFR Parts 801 and 809), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education 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,

Kristian M. Roth - $S_{\text{For:}}$

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

Enclosure

Indications for Use

510(k) Number (if known) K162950

Device Name VITEK® MS

Indications for Use (Describe)

The VITEK® MS is a qualitative in vitro diagnostic device in conjunction with other clinical and laboratory findings to aid in the diagnosis of bacterial, yeast and mould infections.

(See Attached for 'List of Claimed Organisms')

Type of Use (Select one or both, as applicable)

X Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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Indications for Use Attachment

Abiotrophia defectiva Achromobacter denitrificans 1 Achromobacter xylosoxidans ¹ Acinetobacter baumannii complex Acinetobacter haemolyticus Acinetobacter junii Acinetobacter lwoffii Actinomyces meyeri Actinomyces neuii Actinomyces odontolyticus Aerococcus viridans Aeromonas hydrophila/caviae 2 Aeromonas sobria 2 3 Aggregatibacter actinomycetemcomitans Aggregatibacter aphrophilus Aggregatibacter segnis Alcaligenes faecalis ssp faecalis Bacteroides caccae Bacteroides fragilis Bacteroides ovatus 4 Bacteroides thetaiotaomicron Bacteroides uniformis Bacteroides vulgatus Bordetella parapertussis Bordetella pertussis Brevundimonas diminuta Burkholderia multivorans Campylobacter coli Campylobacter jejuni Candida albicans Candida dubliniensis Candida famata Candida glabrata Candida guilliermondii Candida haemulonii Candida inconspicua Candida intermedia Candida kefyr Candida krusei Candida lambica Candida lipolytica Candida lusitaniae Candida norvegensis

Candida parapsilosis Candida pelliculosa Candida rugosa Candida tropicalis Candida utilis Candida zeylanoides Chryseobacterium indologenes Citrobacter amalonaticus Citrobacter braaki 5 Citrobacter freundii 5 Citrobacter koseri Citrobacter youngae 5 Clostridium clostridioforme Clostridium difficile Clostridium perfringens Clostridium ramosum Corynebacterium jeikeium Cronobacter sakazakii Cryptococcus neoformans Edwardsiella hoshinae Edwardsiella tarda Eikenella corrodens Elizabethkingia meningoseptica Enterobacter aerogenes Enterobacter asburiae 6 Enterobacter cancerogenus Enterobacter cloacae 6 Enterococcus avium Enterococcus casseliflavus Enterococcus durans Enterococcus faecalis Enterococcus faecium Enterococcus gallinarum Escherichia coli ' Escherichia fergusonii Escherichia hermannii Ewingella americana Finegoldia magna Fusobacterium necrophorum Fusobacterium nucleatum Gardnerella vaginalis Gemella haemolysans Gemella morbillorum

Granulicatella adiacens Haemophilus influenzae Haemophilus parahaemolyticus Haemophilus parainfluenzae Hafnia alvei Kingella denitrificans Kingella kingae Klebsiella oxytoca Klebsiella pneumoniae Kodamaea ohmeri Lactococcus garvieae Lactococcus lactis ssp lactis 8 Leclercia adecarboxylata Legionella pneumophila Leuconostoc mesenteroides Leuconostoc pseudomesenteroides Listeria monocytogenes Malassezia furfur Malassezia pachydermatis Micrococcus luteus Mobiluncus curtisii Moraxella (Branhamella) catarrhalis Morganella morganii Neisseria cinerea Neisseria gonorrhoeae 9 Neisseria meningitidis Neisseria mucosa 10 Ochrobactrum anthropi Oligella ureolytica Oligella urethralis Pantoea agglomerans Parvimonas micra Pasteurella multocida Pediococcus acidilactici Peptoniphilus asaccharolyticus Peptostreptococcus anaerobius Pluralibacter gergoviae Prevotella bivia Prevotella buccae Prevotella denticola Prevotella intermedia Prevotella melaninogenica Propionibacterium acnes

Proteus mirabilis Proteus penneri 11 Proteus vulgaris 11 Providencia rettgeri Providencia stuartii Pseudomonas aeruginosa Pseudomonas fluorescens Pseudomonas putida Pseudomonas stutzeri Ralstonia pickettii Raoultella ornithinolytica Raoultella planticola Rhizobium radiobacter Rhodotorula mucilaginosa Rothia mucilaginosa Saccharomyces cerevisiae Salmonella group 9 Saprochaete capitata Serratia fonticola Serratia liquefaciens Serratia marcescens Serratia odorifera Sphingobacterium multivorum Sphingobacterium spiritivorum Sphingomonas paucimobilis Staphylococcus aureus Staphylococcus capitis Staphylococcus cohnii ssp cohnii Staphylococcus cohnii ssp urealyticus Staphylococcus epidermidis Staphylococcus haemolyticus Staphylococcus hominis ssp hominis 12 Staphylococcus lugdunensis Staphylococcus saprophyticus Staphylococcus schleiferi Staphylococcus sciuri Staphylococcus simulans Staphylococcus warneri Stenotrophomonas maltophilia Streptococcus agalactiae Streptococcus anginosus Streptococcus constellatus Streptococcus dysgalactiae Streptococcus gallolyticus ssp gallolyticus

Streptococcus infantarius ssp coli Streptococcus infantarius ssp infantarius Streptococcus intermedius Streptococcus mitis/Streptococcus oralis Streptococcus mutans Streptococcus pneumoniae Streptococcus pyogenes Streptococcus salivarius ssp salivarius 13 Streptococcus sanguinis Trichosporon asahii Trichosporon inkin Trichosporon mucoides Vibrio cholerae Vibrio parahaemolyticus Vibrio vulnificus Yersinia enterocolitica Yersinia frederiksenii Yersinia intermedia Yersinia kristensenii Yersinia pseudotuberculosis 14

MYCOBACTERIUM

Mycobacterium abscessus Mycobacterium avium Mycobacterium chelonae Mycobacterium fortuitum group: 15 Mycobacterium alvei Mycobacterium farcinogenes Mycobacterium fortuitum Mycobacterium houstonense Mycobacterium peregrinum Mycobacterium porcinum Mycobacterium senegalense 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: 16 Mycobacterium africanum Mycobacterium bovis Mycobacterium canettii Mycobacterium microti Mycobacterium pinnipedii Mycobacterium tuberculosis Mycobacterium xenopi

NOCARDIA

Nocardia abscessus Nocardia asteroides Nocardia brasiliensis Nocardia cyriacigeorgica Nocardia farcinica Nocardia nova 17 Nocardia otitidiscaviarum Nocardia paucivorans Nocardia pseudobrasiliensis Nocardia transvalensis Nocardia veterana Nocardia wallacei

MOULDS

Acremonium sclerotigenum Alternaria alternata Aspergillus brasiliensis Aspergillus flavus/oryzae Aspergillus fumigatus Aspergillus lentulus Aspergillus nidulans Aspergillus niger complex Aspergillus sydowii Aspergillus terreus complex 18 Aspergillus calidoustus Aspergillus versicolor Blastomyces dermatitidis Cladophialophora bantiana Coccidioides immitis/posadasii Curvularia hawaiiensis Curvularia spicifera Epidermophyton floccosum Exophiala dermatitidis

Exophiala xenobiotica 19 Exserohilum rostratum 19 Fusarium oxysporum complex Fusarium proliferatum Fusarium solani complex Histoplasma capsulatum Lecythophora hoffmannii Lichtheimia corymbifera Microsporum audouinii Microsporum canis Microsporum gypseum Mucor racemosus complex 20 Paecilomyces variotii complex Penicillium chrysogenum

Pseudallescheria boydii Purpureocillium lilacinum Rasamsonia argillacea complex 21 Rhizopus arrhizus complex Rhizopus microsporus complex Sarocladium kiliense Scedosporium apiospermum Scedosporium prolificans Sporothrix schenckii complex Trichophyton interdigitale Trichophyton rubrum Trichophyton tonsurans Trichophyton verrucosum Trichophyton violaceum 22

Achromobacter denitrificans and Achromobacter xylosoxidans identifications should be considered as a slashline result, Achromobacter denitrificans/ Achromobacter xylosoxidans. The final identification should be confirmed before sending the final selection to the VITEK® 2 for AST results
Aeromonas hydrophila/caviae and Aeromonas sobria should be considered as an Aeromonas species group identification.
In KB V3.0.0, Aeromonas sobria is displayed as a low discrimination result with Aeromonas veronii but only Aeromonas sobria has been clinically validated.
In KB V3.0.0. Bacteroides ovatus is grouped in a slashline with Bacteroides xylanisolvens. It is not possible to distinguish between the two species. BB. ovatus is more commonly associated with human infection.
Citrobacter freundii, Citrobacter braakii and Citrobacter youngae should be considered as Citrobacter freundii complex.
Enterobacter cloacae and Enterobacter asburiae identifications should be considered as a slashline result, Enterobacter cloacae/ Enterobacter asburiae. The final identification should be confirmed before sending the final selection to the LIS or to the VITEK® 2 for AST results.
Shigella species and E. coli O157 are identified as Escherichia coli. Confirmatory tests are required to differentiate Escherichia coli from Shigella species or E. coli O157.

8 In KB V3.0.0 Lactococcus lactis is integrated in a new group Lactococcus lactis (with two other subspecies Lactococcus lactis ssp cremoris and Lactococcus lactis ssp hordniae). In the Lactoccus lactis group only subspecies Lactococcus lactis ssp lactis has been clinically validated.

Confirmatory tests recommended for Neisseria gonorrhea and Salmonella species. 9.

In KB V3.0.0, Neisseria mucosa is grouped in a slashline with Neisseria sicca. It is not possible to distinguish between the two species. Both species have been associated with human infection.
Proteus penneri and Proteus vulgaris identifications should be considered as a slashline result. Proteus penneri/ Proteus vulgaris.
In KB V3.0.0 Staphylococcus hominis is integrated in a new group Staphylococus.hominis (with another subspecies S. hominis ssp novobiosepticus). In the Staphylococus.hominis group only subspecies Staphylococcus hominis ssp hominis has been clinically validated.
In KB V3.0.0, Streptococcus salivarius ssp salivarius is displayed as a low discrimination result with Streptococcus salivarius ssp thermophilus and Streptococcus vestibularis but only Streptococcus salivarius ssp salivarius has been clinically validated.

There is a possibility of cross-identification between Yersinia similis and Yersinia pseudotuberculosis
The Mycobacterium fortuitum complex or group displayed in VITEK® MS includes the seven most prominent and closely related species. The VITEK® MS group differs from the ones reported in the literature that may include up to 13 species.
The Mycobacterium tuberculosis complex displayed in VITEK® MS includes the four most prevalent species based on different worldwide geographic regions. It does not include two additional species Mycobacterium microti and Mycobacterium pinnipedii as reported in the literature.
In KB V3.0.0, Nocardia nova is displayed as a low discrimination result with Nocardia africana but only Nocardia nova has been clinically validated.
Both Aspergillus alabamensis and Aspergillus niveus are not identified as Aspergillus terreus complex. No identification is expected with either species.
All of the no identifications for this organism were from multiple replicates of the same isolate.
Mucor racemosus f. sphaerosporus is not identified as Mucor racemosus complex. No identification is expected. The Mucor racemosus complex is comprised of M. racemosus f. brunneus, M. racemosus f. chibinensis, M. racemosus f. racemosus, and M. racemosus f. sphaerosporus.
3 out of the 5 no identifications for this organism were from multiple replicates of the same isolate.
All of the discordant identifications for this organism were from multiple replicates of the same isolate.

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510(k) SUMMARY

VITEK® MS

510(k) Submission Information:

Submitter's Name:	bioMérieux, SA
Address:	3 Route de Port Michaud
La Balme les Grottes, 38390 (France)
Contact Person:	Nathan Hardesty
Manager, Regulatory Affairs Microbiology
Phone Number:	314-731-8666
Fax Number:	314-731-8689
Date of Preparation:	October 14, 2016
Device Name:
Formal/Trade Name:	VITEK® MS
Classification Name:	21 CFR 866.3361, Mass spectrometer system for
clinical use for the identification of microorganisms
Common Name:	VITEK® MS, VITEK MS
Predicate Device:	VITEK® MS (DEN130013 / K124067)

D. 510(k) Summary:

The VITEK® MS is intended for laboratory use by professional users who are trained in microbiology and good laboratory practices.

This 510(k) is an update to the VITEK® MS (Mass Spectrometry) clinical knowledge base (KB v3.0.0) for the purposes of identifying Mycobacterium, Nocardia, and mould isolates. As the VITEK® MS KB v3.0.0 update includes new indications for use on the VITEK® MS system, new clinical data was required to establish safety and effectiveness. To account for the detection of higher mass peaks, relevant for some

bioMérieux, Inc.

moulds and Mycobacterium, the VITEK® MS acquisition station software was optimized (in v1.5.0) .

Clinical strains for all isolates tested from solid and liquid media at all sites combined show an acceptable agreement rate of 94.6% (correct single identification plus a low discrimination correct genus result), as well as with each organism group [moulds (92.7%), mycobacteria (96.5%) and Nocardia (97.9%). A combined very low error rate of 0.7% (19/2695) was obtained with all isolates tested, and the combined no identification rate was acceptable at 4.7% (127/2695).

with each organism group [moulds (99.1%), mycobacteria (99.6%) and Nocardia (99.2%)]. A very low error rate of 0.7% (19/2568) was obtained with all isolates combined.