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510(K) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY A. 510(k) Number: K162950 B. Purpose for Submission: To add the additional organism identification claims (moulds, mycobacteria and nocardia) to the already cleared device DEN130013 (K124067). C. Measurand: See Intended Use D. 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 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. E. Applicant: bioMérieux, Inc. F. Proprietary and Established Names: VITEK MS G. Regulatory Information: 1. Regulation section: 21 CFR 866. 3361 2. Classification: Class II (special controls) 3. Product code: PEX 4. Panel: Microbiology (83) H. Intended Use: 1. Intended use(s): VITEK MS is a mass spectrometer system using matrix-assisted laser desorption/ionization - time to flight (MALDI-TOF) for the identification of microorganisms cultured from human specimens. The VITEK MS 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. The following organisms are claimed: 1 Abiotrophia defectiva Candida parapsilosis 1 Achromobacter denitrificans Candida pelliculosa Achromobacter xylosoxidans 1 Candida rugosa Acinetobacter baumannii complex Candida tropicalis Acinetobacter haemolyticus Candida utilis Acinetobacter junii Candida zeylanoides Acinetobacter lwoffii Chryseobacterium indologenes Actinomyces meyeri Citrobacter amalonaticus Actinomyces neuii Citrobacter braaki 5 5 Actinomyces odontolyticus Citrobacter freundii Aerococcus viridans Citrobacter koseri 2 5 Aeromonas hydrophila/caviae Citrobacter youngae Aeromonas sóbria 2,3 Clostridium clostridioforme Aggregatibacter actinomycetemcomitans Clostridium difficile Aggregatibacter aphrophilus Clostridium perfringens Aggregatibacter segnis Clostridium ramosum Alcaligenes faecalis ssp faecalis Corynebacterium jeikeium Bacteroides caccae Cronobacter sakazakii Bacteroides fragilis Cryptococcus neoformans Bacteroides ovatus 4 Edwardsiella hoshinae Bacteroides thetaiotaomicron Edwardsiella tarda Bacteroides uniformis Eikenella corrodens Bacteroides vulgatus Elizabethkingia meningoseptica Bordetella parapertussis Enterobacter aerogenes 6 Bordetella pertussis Enterobacter asburiae Brevundimonas diminuta Enterobacter cancerogenus 6 Burkholderia multivorans Enterobacter cloacae Campylobacter coli Enterococcus avium Campylobacter jejuni Enterococcus casseliflavus Candida albicans Enterococcus durans Candida dubliniensis Enterococcus faecalis Candida famata Enterococcus faecium Candida glabrata Enterococcus gallinarum Candida guilliermondii Escherichia coli 7 Candida haemulonii Escherichia fergusonii Candida inconspicua Escherichia hermannii Candida intermedia Ewingella americana Candida kefyr Finegoldia magna Candida krusei Fusobacterium necrophorum Candida lambica Fusobacterium nucleatum Candida lipolytica Gardnerella vaginalis Candida lusitaniae Gemella haemolysans Candida norvegensis Gemella morbillorum 2 Geotrichum capitatum Proteus mirabilis 11 Granulicatella adiacens Proteus penneri Haemophilus influenzae Proteus vulgaris 11 Haemophilus parahaemolyticus Providencia rettgeri Haemophilus parainfluenzae Providencia stuartii Hafnia alvei Pseudomonas aeruginosa Kingella denitrificans Pseudomonas fluorescens Kingella kingae Pseudomonas putida Klebsiella oxytoca Pseudomonas stutzeri Klebsiella pneumoniae Ralstonia pickettii Kodamaea ohmeri Raoultella ornithinolytica Lactococcus garvieae Raoultella planticola Lactococcus lactis ssp lactis 8 Rhizobium radiobacter Leclercia adecarboxylata Rhodotorula mucilaginosa Legionella pneumophila Rothia mucilaginosa Leuconostoc mesenteroides Saccharomyces cerevisiae Leuconostoc pseudomesenteroides Salmonella group 9 Listeria monocytogenes Saprochaete capitata Malassezia furfur Serratia fonticola Malassezia pachydermatis Serratia liquefaciens Micrococcus luteus Serratia marcescens Mobiluncus curtisii Serratia odorifera Moraxella (Neisseria) ovis Sphingobacterium multivorum Morganella morganii Sphingobacterium spiritivorum Neisseria cinerea Sphingomonas paucimobilis 9 Neisseria gonorrhoeae Staphylococcus aureus Neisseria meningitidis Staphylococcus capitis Neisseria mucosa 10 Staphylococcus cohnii ssp cohnii Ochrobactrum anthropi Staphylococcus cohnii ssp urealyticus Oligella ureolytica Staphylococcus epidermidis Oligella urethralis Staphylococcus haemolyticus Pantoea agglomerans Staphylococcus hominis ssp hominis 12 Parvimonas micra Staphylococcus lugdunensis Pasteurella multocida Staphylococcus saprophyticus Pediococcus acidilactici Staphylococcus schleiferi Peptoniphilus asaccharolyticus Staphylococcus sciuri Peptostreptococcus anaerobius Staphylococcus simulans Pluralibacter gergoviae Staphylococcus warneri Prevotella bivia Stenotrophomonas maltophilia Prevotella buccae Streptococcus agalactiae Prevotella denticola Streptococcus anginosus Prevotella intermedia Streptococcus constellatus Prevotella melaninogenica Streptococcus dysgalactiae Propionibacterium acnes Streptococcus gallolyticus ssp gallolyticus 3 Streptococcus infantarius ssp coli Mycobacterium tuberculosis complex: 16 Streptococcus infantarius ssp infantarius Mycobacterium africanum Streptococcus intermedius Mycobacterium bovis Streptococcus mitis/Streptococcus oralis Mycobacterium canettii Streptococcus mutans Mycobacterium microti Streptococcus pneumoniae Mycobacterium pinnipedii Streptococcus pyogenes Mycobacterium tuberculosis Streptococcus salivarius ssp salivarius 13 Mycobacterium xenopi Streptococcus sanguinis Trichosporon asahii NOCARDIA Trichosporon inkin Trichosporon mucoides Nocardia abscessus Vibrio cholerae Nocardia asteroides Vibrio parahaemolyticus Nocardia brasiliensis Vibrio vulnificus Nocardia cyriacigeorgica Yersinia enterocolitica Nocardia farcinica Yersinia frederiksenii Nocardia nova 17 Yersinia intermedia Nocardia otitidiscaviarum Yersinia kristensenii Nocardia paucivorans Yersinia pseudotuberculosis 14 Nocardia pseudobrasiliensis Nocardia transvalensis MYCOBACTERIUM Nocardia veterana Nocardia wallacei Mycobacterium abscessus Mycobacterium avium MOULDS Mycobacterium chelonae Mycobacterium fortuitum group: 15 Acremonium sclerotigenum Mycobacterium alvei Alternaria alternata Mycobacterium farcinogenes Aspergillus brasiliensis Mycobacterium fortuitum Aspergillus flavus/oryzae Mycobacterium houstonense Aspergillus fumigatus Mycobacterium peregrinum Aspergillus lentulus Mycobacterium porcinum Aspergillus nidulans Mycobacterium senegalense Aspergillus niger complex Mycobacterium gordonae Aspergillus sydowii Mycobacterium haemophilum Aspergillus terreus complex 18 Mycobacterium immunogenum Aspergillus calidoustus Mycobacterium intracellulare Aspergillus versicolor Mycobacterium kansasii Blastomyces dermatitidis Mycobacterium lentiflavum Cladophialophora bantiana Mycobacterium malmoense Coccidioides immitis/posadasii Mycobacterium marinum Curvularia hawaiiensis Mycobacterium mucogenicum Curvularia spicifera Mycobacterium scrofulaceum Epidermophyton floccosum Mycobacterium simiae Exophiala dermatitidis Mycobacterium smegmatis Mycobacterium szulgai 4 Exophiala xenobiotica 19 Pseudallescheria boydii Exserohilum rostratum 19 Purpureocillium lilacinum Fusarium oxysporum complex Rasamsonia argillacea complex 21 Fusarium proliferatum Rhizopus arrhizus complex Fusarium solani complex Rhizopus microsporus complex Histoplasma capsulatum Sarocladium kiliense Lecythophora hoffmannii Scedosporium apiospermum Lichtheimia corymbifera Scedosporium prolificans Microsporum audouinii Sporothrix schenckii complex Microsporum canis Trichophyton interdigitale Microsporum gypseum Trichophyton rubrum Mucor racemosus complex 20 Trichophyton tonsurans Paecilomyces variotii complex Trichophyton verrucosum Penicillium chrysogenum Trichophyton violaceum 22 1. 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 LIS or to the VITEK 2 for AST results 2. Aeromonas hydrophila/caviae and Aeromonas sobria should be considered as an Aeromonas species group identification. 3. 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. 4. 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. B. ovatus is more commonly associated with human infection. 5. Citrobacter freundii, Citrobacter braakii and Citrobacter youngae should be considered as Citrobacter freundii complex. 6. 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. 7. 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
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