K Number
K142677
Device Name
MALDI Biotyper CA System
Date Cleared
2015-03-27

(189 days)

Product Code
Regulation Number
866.3361
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Bruker Daltonics, Inc. MALDI Biotyper CA System is a mass spectrometer system using matrix-assisted laser desorption/ionization – time-of-flight (MALDI-TOF) for the identification of microorganisms cultured from human specimens. The MALDI Biotyper CA 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 yeast infections.
Device Description
The Bruker Daltonics, Inc. MALDI Biotyper CA System is a mass spectrometer system using matrix-assisted laser desorption/ionization – time-of-flight (MALDI-TOF) for the identification of microorganisms cultured from human specimens. The system measures the time (in the nanosecond range) between pulsed acceleration and the corresponding detector signal, the speed is converted into an exact molecular mass. The mass-to-charge ratio of an ion is proportional to the square of its drift time. Highly abundant microbial proteins (mainly ribosomal proteins) result in a mass spectrum with characteristic mass and intensity distribution. It is specific for many bacteria and is interpreted as a molecular fingerprint to identify the test organism.
More Information

Not Found

Yes
The document explicitly states that the device uses an algorithm based on supervised machine learning known as the "Advanced Spectrum Classifier".

No
The device is described as an "in vitro diagnostic device indicated for use in conjunction with other clinical and laboratory findings to aid in the diagnosis of bacterial and yeast infections." It does not directly treat or prevent a disease or condition.

Yes

Explanation: The "Intended Use / Indications for Use" section explicitly states, "The MALDI Biotyper CA 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 yeast infections."

No

The device is described as a "mass spectrometer system" and the description details the physical process of MALDI-TOF, indicating it includes significant hardware components beyond just software.

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

Here's why:

  • Explicit Statement in Intended Use: The "Intended Use / Indications for Use" section clearly states: "The MALDI Biotyper CA 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 yeast infections."
  • Purpose: The device is intended to identify microorganisms cultured from human specimens to aid in the diagnosis of infections. This is a classic function of an in vitro diagnostic device.
  • Use of Human Specimens: The device analyzes microorganisms cultured from human specimens, which is a key characteristic of IVDs.
  • Laboratory Setting: The intended user is a trained microbiologist in a laboratory setting, which is where IVD testing typically occurs.

No
The letter does not state that the FDA has reviewed and approved or cleared a Predetermined Change Control Plan (PCCP) for this specific device. The field "Control Plan Authorized (PCCP) and relevant text" is listed as "Not Found".

Intended Use / Indications for Use

The Bruker Daltonics, Inc. MALDI Biotyper CA System is a mass spectrometer system using matrix-assisted laser desorption/ionization – time-of-flight (MALDI-TOF) for the identification of microorganisms cultured from human specimens.

The MALDI Biotyper CA 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 yeast infections.

Product codes

PEX

Device Description

Not Found

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

human specimens

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

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

Precision/Repeatability:
Validation of the whole MALDI Biotyper CA System was performed on six (6) working days with two (2) runs/day following manufacturer's instructions for use. Ten (10) test organisms were tested in triplicate via Direct Transfer (DT) and extended Direct Transfer (eDT) in each run. If a replicate yielded a log(score)

§ 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.

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

BRUKER DALTONICS, INC MARKUS KOSTRZEWA VICE PRESIDENT CLINICAL MASS SPECTROMETRY R&D FAHRENHEILSTRASSE-4 BREMEN 28359 DE

March 27, 2015

Re: K142677 Trade/Device Name: MALDI Biotyper CA System 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: February 27, 2015 Received: March 2, 2015

Dear Dr. Kostrzewa:

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

1

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,

Uwe Scherf - S for

Sally Hojvat, M.Sc., PhD. Director Division of Microbiology Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

2

Indications for Use

510(k) Number (if known) K142677

Device Name

MALDI Biotyper CA System

Indications for Use (Describe)

The Bruker Daltonics, Inc. MALDI Biotyper CA System is a mass spectrometer system using matrix-assisted laser desorption/ionization – time-of-flight (MALDI-TOF) for the identification of microorganisms cultured from human specimens.

The MALDI Biotyper CA 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 yeast infections.

BACTERIA

Achromobacter xylosoxidans Acinetobacter baumannii complex [4] Acinetobacter haemolyticus Acinetobacter johnsonii Acinetobacter junii Acinetobacter lwoffii Acinetobacter radioresistens Acinetobacter ursingii Actinomyces meyeri Actinomyces neuii Actinomyces odontolyticus Actinomyces oris Aerococcus urinae Aerococcus viridans Aeromonas salmonicida Aeromonas sp[7] Alcaligenes faecalis Anaerococcus vaginalis Bacteroides fragilis Bacteroides ovatus group Bacteroides thetaiotaomicron group Bacteroides uniformis Bacteroides vulgatus group Bordetella group[3] Bordetella hinzii Brevibacterium casei Brevundimonas diminuta group Burkholderia cepacia complex [13] Burkholderia gladioli Burkholderia multivorans Campylobacter coli Campylobacter jejuni Campylobacter ureolyticus Capnocytophaga ochracea Capnocytophaga sputigena

3

Chryseobacterium gleum Chryseobacterium indologenes Citrobacter amalonaticus complex Citrobacter freundii complex Citrobacter koseri Clostridium difficile Clostridium perfringens Corynebacterium amycolatum Corynebacterium aurimucosum group Corynebacterium bovis Corynebacterium diphtheriae Corynebacterium glucuronolyticum Corynebacterium jeikeium Corynebacterium kroppenstedtii Corynebacterium macginleyi Corynebacterium minutissimum Corynebacterium propinquum Corynebacterium pseudodiphtheriticum Corynebacterium riegelii Corynebacterium striatum group Corynebacterium tuberculostearicum Corynebacterium ulcerans Corynebacterium urealyticum Corynebacterium xerosis Cronobacter sakazakii group Cupriavidus pauculus group Delftia acidovorans group Dermacoccus nishinomiyaensis Edwardsiella tarda Eikenella corrodens Elizabethkingia meningoseptica group Enterobacter aerogenes Enterobacter amnigenus Enterobacter cloacae complex Enterococcus avium group Enterococcus casseliflavus Enterococcus faecalis Enterococcus faecium Enterococcus gallinarum Enterococcus hirae Escherichia coli Finegoldia magna Fusobacterium canifelinum Fusobacterium necrophorum Fusobacterium nucleatum Gardnerella vaginalis Gemella haemolysans Gemella sanguinis Granulicatella adiacens Haemophilus haemolyticus Haemophilus influenzae Haemophilus parahaemolyticus group Haemophilus parainfluenzae Hafnia alvei

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Kingella kingae Klebsiella oxytoca / Raoultella ornithinolytica Klebsiella pneumoniae Kocuria kristinae Kytococcus sedentarius Lactococcus garvieae Lactococcus lactis Leuconostoc mesenteroides Macrococcus caseolyticus Micrococcus luteus Moraxella sg Branhamella catarrhalis Moraxella sg Moraxella nonliquefaciens Moraxella sg Moraxella osloensis Morganella morganii Myroides odoratimimus Myroides odoratus Oligella ureolytica Oligella urethralis Pantoea agglomerans Parabacteroides distasonis Pasteurella multocida Pediococcus pentosaceus Peptoniphilus harei group Peptostreptococcus anaerobius Plesiomonas shigelloides Porphyromonas gingivalis Prevotella bivia Prevotella buccae Prevotella denticola Prevotella intermedia Prevotella melaninogenica Propionibacterium acnes Proteus mirabilis Proteus vulgaris group Providencia rettgeri Providencia stuartii Pseudomonas aeruginosa Pseudomonas fluorescens group Pseudomonas oryzihabitans Pseudomonas putida group Pseudomonas stutzeri Rhizobium radiobacter Rothia aeria Rothia dentocariosa Rothia mucilaginosa Salmonella sp Serratia liquefaciens Serratia marcescens Serratia plymuthica Serratia rubidaea Staphylococcus aureus Staphylococcus auricularis Staphylococcus capitis Staphylococcus caprae

5

Staphylococcus carnosus Staphylococcus cohnii Staphylococcus epidermidis Staphylococcus equorum Staphylococcus felis Staphylococcus haemolyticus Staphylococcus hominis Staphylococcus lugdunensis Staphylococcus pasteuri Staphylococcus pettenkoferi Staphylococcus pseudintermedius Staphylococcus saccharolyticus Staphylococcus saprophyticus Staphylococcus schleiferi Staphylococcus simulans Staphylococcus vitulinus Staphylococcus warneri Stenotrophomonas maltophilia Streptococcus agalactiae Streptococcus anginosus Streptococcus constellatus Streptococcus dysgalactiae Streptococcus gallolyticus Streptococcus gordonii Streptococcus intermedius Streptococcus lutetiensis Streptococcus mitis / oralis group Streptococcus mutans Streptococcus pneumoniae Streptococcus pyogenes Streptococcus salivarius Sutterella wadsworthensis Vibrio parahaemolyticus Vibrio vulnificus Yersinia enterocolitica Yersinia pseudotuberculosis

YEAST

Candida albicans Candida boidinii Candida dubliniensis Candida duobushaemulonii Candida famata Candida glabrata Candida guilliermondii Candida haemulonis Candida inconspicua Candida kefyr Candida krusei Candida lambica Candida lipolytica Candida lusitaniae Candida metapsilosis Candida norvegensis

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Candida orthopsilosis Candida parapsilosis Candida pararugosa Candida pelliculosa Candida tropicalis Candida valida Cryptococcus gattii Cryptococcus neoformans var grubii Cryptococcus neoformans var neoformans Geotrichum candidum Geotrichum capitatum Kloeckera apiculata Pichia ohmeri Saccharomyces cerevisiae Trichosporon asahii

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

Prescription Use (Part 21 CFR 801 Subpart D)

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

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Image /page/7/Picture/0 description: The image shows the logo for Bruker. The word "BRUKER" is written in a bold, sans-serif font. Above and below the word are blue lines that form a circular shape, with a blue dot at each end of the lines. The logo is simple and modern.

510(k) SUMMARY

Date of Summary:March 27, 2015
Product NameMBT-CA System
SponsorBruker Daltonics, Inc.
40 Manning Road,
Billerica, MA 01821
CorrespondentBruker Daltonik GmbH
Markus Kostrzewa, Vice President Clinical Mass Spectrometry R&D
Fahrenheitstrasse 4
Bremen, 28359
Phone: +49 (0)421-2205 1258Fax: +49 (0)421-2205 205
Email: Markus.Kostrzewa@bruker.com
Device Identification
Trade or Proprietary Name:MALDI Biotyper CA System
Common or Usual Name:System, mass spectrometry, maldi tof, microorganism identification,
cultured isolates
Product Code:DEV
Product Code:PEX
Regulation Section:21 CFR 866.3361
Device Class:Class II
Panel:Microbiology

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Image /page/8/Picture/0 description: The image shows the logo for Bruker. The logo consists of the word "BRUKER" in bold, black letters. Above the word is a blue atom symbol, which is a common symbol used to represent science and technology. The atom symbol has three orbits with two dots on each orbit.

Substantial Equivalency

The Bruker Daltonics, Inc. MBT-CA System is substantially equivalent to the MS (K124067) and the Bruker Datonics, Inc. MBT-CA System (K13083). Table 1 compares the characteristics of the MBT-CA System (New Device) and the Vitek MS (Predicate Device).

Table 1. Substantial Equivalency Table

Similarities
NEW DEVICEPRIMARY PREDICATE DEVICEPREDICATE DEVICE
CharacteristicBruker Daltonics, Inc. MBT-CA SystemVitek® MSBruker Daltonics, Inc. MBT-CA
(TBD)(K124067)System (K130831)
Product CodesPEXPEXPEX
Intended useThe Bruker Daltonics, Inc. MALDI Biotyper CA System is a mass
spectrometer system using matrix-assisted laser
desorption/ionization - time-of-flight (MALDI-TOF) for the
identification of microorganisms cultured from human
specimens.
The MALDI Biotyper CA 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 yeast infections.The Vitek® MS is a mass spectrometer system
using matrix-assisted laser
desorption/ionization-time-of- flight (MALDI-
TOF) for the identification of microorganisms
cultured from human specimen.
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 and yeast infections.See "Differences"
Sample typeIsolated colony from any patient sample source.
Acceptable media:
• Columbia blood agar with 5% sheep blood
• Trypticase soy agar with 5% sheep Blood
• Chocolate agar
• MacConkey Agar
• Columbia CNA agar with 5% sheep blood
• Brucella Agar with 5% horse blood
• CDC anaerobe Agar with 5% sheep blood
• CDC anaerobe 5% sheep blood Agar with phenylethyl alcohol
• CDC anaerobe laked sheep blood Agar with kanamycin and
vancomycin
• Bacteroides bile esculin Agar with amikacin
• Clostridium difficile Agar with 7% sheep blood
• Sabouraud-Dextrose Agar
• Brain Heart Infusion Agar
• Campylobacter Agar with 5 Antimicrobics and 10% Sheep
Blood
• Bordet Gengou Agar with 15% sheep bloodIsolated colony from any patient sample
source.
Acceptable media:
• Columbia blood agar with 5% sheep blood
• Trypitcase soy agar with 5% sheep Blood
• Chocolate polyvitex agar
• Campylosel agar
• MacConkey Agar
• Modified Sabouraud dextrose Agar
• ChromID CPSIsolated colony from any patient sample
source.
Acceptable media:
• Columbia blood agar with 5% sheep
blood
• Trypticase soy agar with 5% sheep
Blood
• Chocolate agar
• MacConkey Agar
Type of TestAutomated Mass Spectrometry SystemAutomated Mass Spectrometry SystemAutomated Mass Spectrometry System
Similarities
CharacteristicNEW DEVICE
Bruker Daltonics, Inc. MBT-CA System
(TBD)PRIMARY PREDICATE DEVICE
Vitek® MS
(K124067)PREDICATE DEVICE
Bruker Daltonics, Inc. MBT-CA
System (K130831)
Matrixα-Cyano-4-hydroxycinnamic acidα-Cyano-4-hydroxycinnamic acidα-Cyano-4-hydroxycinnamic acid
Method of
TestingBacteria & Yeast: Direct testing
If after initial analysis the log(score) is reported at in vitro
diagnostic device indicated for use in conjunction with
other clinical and laboratory findings to aid in the
diagnosis of bacterial and yeast infections.See "Similarities"The Bruker Daltonics, Inc. MALDI Biotyper CA
System is a qualitative in vitro diagnostic mass
spectrometer system for the identification of Gram-
negative bacterial colonies cultured from human
specimens using matrix-assisted laser
desorption/ionization - time-of-flight (MALDI-TOF)
mass spectrometry technology.

The MALDI Biotyper CA System is indicated for use
in conjunction with other clinical and laboratory
findings to aid in the diagnosis of Gram-negative
bacterial infections. |

These differences do not affect substantial equivalence of the MBT-CA System and MBT-CA System (K130831). All systems are mass spectrometers using matrix-assisted laser desorption – time-of-flight (MALDI-TOF) for the identification of microorganisms cultured from human specimens. The differences noted above do not impact the intended use and do not raise questions as to the safectiveness of the test (new) device.

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Image /page/12/Picture/0 description: The image shows the Bruker logo. The logo consists of the word "BRUKER" in bold, sans-serif font, with a stylized graphic above it. The graphic features two intersecting, curved lines that form a circular shape, with small circles at the ends of the lines, resembling an atom or molecule. The logo is simple and modern, conveying a sense of scientific precision and innovation.

Intended Use

The Bruker Daltonics, Inc. MALDI Biotyper CA System is a mass spectrometer system using matrix-assisted laser desorption/ionization – time-of-flight (MALDI-TOF) for the identification of microorganisms cultured from human specimens.

The MALDI Biotyper CA 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 yeast infections.

The following organisms are claimed:

Bacteria:

Achromobacter xylosoxidansCupriavidus pauculus groupPropionibacterium acnes
Acinetobacter haemolyticusDelftia acidovorans groupProteus mirabilis
Acinetobacter johnsoniiDermacoccus nishinomiyaensisProteus vulgaris group
Acinetobacter juniiEdwardsiella tardaProvidencia rettgeri
Acinetobacter lwoffiiEikenella corrodensProvidencia stuartii
Acinetobacter radioresistensElizabethkingia meningoseptica groupPseudomonas aeruginosa
Acinetobacter ursingiiEnterobacter aerogenesPseudomonas fluorescens group
Acinetobacter baumannii complex [4]Enterobacter amnigenusPseudomonas oryzihabitans
Actinomyces meyeriEnterobacter cloacae complexPseudomonas putida group
Actinomyces neuiiEnterococcus casseliflavusPseudomonas stutzeri
Actinomyces odontolyticusEnterococcus faecalisRhizobium radiobacter
Actinomyces orisEnterococcus faeciumRothia aeria
Aerococcus urinaeEnterococcus gallinarumRothia dentocariosa
Aerococcus viridansEnterococcus hiraeRothia mucilaginosa
Aeromonas salmonicidaEnterococcus avium groupSalmonella sp
Aeromonas sp[7]Escherichia coliSerratia liquefaciens
Alcaligenes faecalisFinegoldia magnaSerratia marcescens
Anaerococcus vaginalisFusobacterium canifelinumSerratia plymuthica
Bacteroides fragilisFusobacterium necrophorumSerratia rubidaea
Bacteroides uniformisFusobacterium nucleatumStaphylococcus aureus
Bacteroides ovatus groupGardnerella vaginalisStaphylococcus auricularis
Bacteroides thetaiotaomicron groupGemella haemolysansStaphylococcus capitis
Bacteroides vulgatus groupGemella sanguinisStaphylococcus caprae
Bordetella group[3]Granulicatella adiacensStaphylococcus carnosus
Bordetella hinziiHaemophilus haemolyticusStaphylococcus cohnii
Brevibacterium caseiHaemophilus influenzaeStaphylococcus epidermidis
Brevundimonas diminuta groupHaemophilus parainfluenzaeStaphylococcus equorum
Burkholderia gladioliHaemophilus parahaemolyticus groupStaphylococcus felis
Burkholderia multivoransHafnia alveiStaphylococcus haemolyticus
Burkholderia cepacia complex [13]Kingella kingaeStaphylococcus hominis
Campylobacter coliKlebsiella pneumoniaeStaphylococcus lugdunensis
Campylobacter jejuniKlebsiella oxytoca /Staphylococcus pasteuri
Raoultella ornithinolytica
Campylobacter ureolyticusKocuria kristinaeStaphylococcus pettenkoferi
Capnocytophaga ochraceaKytococcus sedentariusStaphylococcus pseudintermedius
Capnocytophaga sputigenaLactococcus garvieaeStaphylococcus saccharolyticus

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Image /page/13/Picture/0 description: The image shows the logo for Bruker. The logo consists of the word "BRUKER" in a bold, sans-serif font, with a stylized atom symbol to the right. The atom symbol is made up of three overlapping circles, with a small dot in the center of each circle. The logo is simple and modern, and the atom symbol suggests that the company is involved in science or technology.

Chryseobacterium gleumLactococcus lactisStaphylococcus saprophyticus
Chryseobacterium indologenesLeuconostoc mesenteroidesStaphylococcus schleiferi
Citrobacter amalonaticus complexMacrococcus caseolyticusStaphylococcus simulans
Citrobacter koseriMicrococcus luteusStaphylococcus vitulinus
Citrobacter freundii complexMoraxella sg Branhamella catarrhalisStaphylococcus warneri
Clostridium difficileMoraxella sg Moraxella
nonliquefaciensStenotrophomonas maltophilia
Clostridium perfringensMoraxella sg Moraxella osloensisStreptococcus agalactiae
Corynebacterium amycolatumMorganella morganiiStreptococcus anginosus
Corynebacterium bovisMyroides odoratimimusStreptococcus constellatus
Corynebacterium diphtheriaeMyroides odoratusStreptococcus dysgalactiae
Corynebacterium glucuronolyticumOligella ureolyticaStreptococcus gallolyticus
Corynebacterium jeikeiumOligella urethralisStreptococcus gordonii
Corynebacterium kroppenstedtiiPantoea agglomeransStreptococcus intermedius
Corynebacterium macginleyiParabacteroides distasonisStreptococcus lutetiensis
Corynebacterium minutissimumPasteurella multocidaStreptococcus mutans
Corynebacterium propinquumPediococcus pentosaceusStreptococcus pneumoniae
Corynebacterium
pseudodiphtheriticumPeptoniphilus harei groupStreptococcus pyogenes
Corynebacterium riegeliiPeptostreptococcus anaerobiusStreptococcus salivarius
Corynebacterium tuberculostearicumPlesiomonas shigelloidesStreptococcus mitis / oralis group
Corynebacterium ulceransPorphyromonas gingivalisSutterella wadsworthensis
Corynebacterium urealyticumPrevotella biviaVibrio parahaemolyticus
Corynebacterium xerosisPrevotella buccaeVibrio vulnificus
Corynebacterium aurimucosum groupPrevotella denticolaYersinia enterocolitica
Corynebacterium striatum groupPrevotella intermediaYersinia pseudotuberculosis
Cronobacter sakazakii groupPrevotella melaninogenica

Yeast:

  • Candida albicans Candida boidinii Candida dubliniensis Candida duobushaemulonii Candida glabrata Candida famata Candida guilliermondii Candida haemulonis Candida inconspicua Candida kefyr Candida krusei Candida lambica Candida lipolytica Candida lusitaniae Candida metapsilosis Candida norvegensis Candida orthopsilosis
  • Candida parapsilosis Candida pararugosa Candida pelliculosa Candida tropicalis Candida valida Cryptococcus gattii Cryptococcus neoformans_var_grubii Cryptococcus neoformans var neoformans Geotrichum candidum Geotrichum capitatum Kloeckera apiculata Pichia ohmeri Saccharomyces cerevisiae Trichosporon asahii

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Image /page/14/Picture/0 description: The image shows the logo for Bruker Corporation. The logo consists of the word "BRUKER" in bold, black letters. Above the word is a blue atom symbol with two electrons orbiting the nucleus. The atom symbol is stylized and has a modern look.

Methodology

Biochemical methods are currently the most commonly used methods for the identification of microorganisms. Organisms are tested against a range of reagents and organism identification is based on a microorganism's reaction to these reagents.

The MBT-CA System uses a different methodology for organism identification based on unique protein patterns of the microorganisms obtained from mass spectrometry. The test organism's spectrum (a pattern of mass peaks) is compared with a reference spectra library (database). Using biostatistical analysis, a probability ranking of the organism identification is generated. The probability ranking is represented as a log(score) between 0.00 and 3.00. Organism identification is reported with high confidence if the log(score) is ≥2.00. An organism identification is reported with low confidence if the log(score) is between 1.70 and