FDA.reportPublic FDA data

MALDI Biotyper sirius one CA System

Primary DI
04251204326311
Brand
MALDI Biotyper sirius one CA System
Company
Bruker Daltonik GmbH
Model
1890232
Catalog number
1890232
Device description
Biotyper system for clinical use in the USA, with smartbeam laser.
Published
2020-12-09
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
PEXSystem, mass spectrometry, maldi tof, microorganism identification, cultured isolates

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PEXSystem, Mass Spectrometry, Maldi Tof, Microorganism Identification, Cultured IsolatesMicrobiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K163536000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K163536000MALDI Biotyper CA (MBT-CA) System, MBT smart CA SystemBruker Daltonik GmbH2017-07-26PEX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04251204326311PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04251204326311042512043263114251204326311

GMDN Terms#

Term, Definition table
TermDefinition
Microbial identification mass spectrometry system IVDAn assembly of mains electricity (AC-powered) devices intended to be used for the qualitative detection and identification of microbial species (bacteria, fungi) in a clinical specimen using mass spectrometry. It typically consists of a sample handling/preparation unit, a mass spectrometry instrument, and a server with software intended to analyse results and compare the produced spectra with information in a remote database to identify and report the microbial species in the specimen. The system operates with reduced technician involvement and automation of some, but not all, procedural steps.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Humidity20 Percent (%) Relative Humidity75 Percent (%) Relative Humidity
Handling Environment Temperature61 Degrees Fahrenheit86 Degrees Fahrenheit
Special Storage Condition, Specify00non-condensing at 91F
Special Storage Condition, Specify00non-condensing, for reference only
Special Storage Condition, Specify00operating altitude
Storage Environment Atmospheric Pressure079500 KiloPascal
Storage Environment Humidity15 Percent (%) Relative Humidity85 Percent (%) Relative Humidity
Storage Environment Temperature50 Degrees Fahrenheit104 Degrees Fahrenheit

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(877)442-2231ms.support.us@bruker.com

Regulatory Flags#

DUNS number
318387958
Device count
1
DM exempt
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04251204328278MBT Compass HT CA18926452025-11-28
04251204328285MBT HT Sepsityper CA Module18926462025-11-28
04251204328728MBT FAST Shuttle US IVD18961332025-11-28
04251204326182MBT Sepsityper Kit US IVD186756518675652021-02-11
04251204326298MBT Galaxy System - US IVD187505418750542021-02-11
04251204326304MBT Pilot System - US IVD187505818750582021-02-11
04251204300014MALDI Biotyper CA System860346486034642017-02-25
04251204325642US IVD-Bruker Bacterial Test Standard, 5 Tubes860453086045302017-02-25
04251204325659US IVD-HCCA Matrix, Portioned 10 Tubes860453186045312017-02-25
04251204325666US IVD 48 Spot Target860453286045322017-02-25
04251204325710MBT-CA System BD860473686047362017-02-25
04251204325734MALDI Biotyper - smart CA860478486047842017-02-25
04251204326175MALDI Biotyper-BD sirius CA System189013318901332020-12-09
04251204326359MALDI Biotyper-BD sirius one CA System189023318902332020-12-09
04251204326168MALDI Biotyper sirius CA System189013218901322019-07-01
04251204325772MBT Biotarget 96 US IVD184038018403802018-01-31
04251204325789US IVD-HCCA Matrix, Portioned 10 Tubes/7.5mg each185213218521322018-01-31

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
03573026637200VITEK® MS SOFTWARE v1.2BIOMERIEUX SAPEX2025-04-29
03573026628154VITEK® MS knowledge base v3.3BIOMERIEUX SAPEX2023-11-14
03573026621698VITEK® MS SOFTWARE v1.1BIOMERIEUX SAPEX2021-11-03
04251204326182MBT Sepsityper Kit US IVDBruker Daltonik GmbHPEX2021-02-11
04251204326298MBT Galaxy System - US IVDBruker Daltonik GmbHPEX2021-02-11
04251204326304MBT Pilot System - US IVDBruker Daltonik GmbHPEX2021-02-11
04251204326175MALDI Biotyper-BD sirius CA SystemBruker Daltonik GmbHPEX2020-12-09
04251204326359MALDI Biotyper-BD sirius one CA SystemBruker Daltonik GmbHPEX2020-12-09
04251204326168MALDI Biotyper sirius CA SystemBruker Daltonik GmbHPEX2019-07-01
03573026610418VITEK®MSBIOMERIEUX SAPEX2019-04-30
04251204325772MBT Biotarget 96 US IVDBruker Daltonik GmbHPEX2018-01-31
04251204325789US IVD-HCCA Matrix, Portioned 10 Tubes/7.5mg eachBruker Daltonik GmbHPEX2018-01-31
03573026436971VITEK® MS MYCOBACTERIUM/NOCARDIA KITBIOMERIEUX SAPEX2017-08-21
03573026437282VITEK® MS MOULD KITBIOMERIEUX SAPEX2017-08-21
04251204300014MALDI Biotyper CA SystemBruker Daltonik GmbHPEX2017-02-25
04251204325642US IVD-Bruker Bacterial Test Standard, 5 TubesBruker Daltonik GmbHPEX2017-02-25
04251204325659US IVD-HCCA Matrix, Portioned 10 TubesBruker Daltonik GmbHPEX2017-02-25
04251204325666US IVD 48 Spot TargetBruker Daltonik GmbHPEX2017-02-25
04251204325710MBT-CA System BDBruker Daltonik GmbHPEX2017-02-25
04251204325734MALDI Biotyper - smart CABruker Daltonik GmbHPEX2017-02-25
03573026554224VITEK® MS-DSBIOMERIEUX SAPEX2016-12-23
03573026359096VITEK® MS-DSBIOMERIEUX SAPEX2016-12-23
03573026555559VITEK® MS FABIOMERIEUX SAPEX2016-12-19
03573026556662VITEK® MS CHCABIOMERIEUX SAPEX2016-12-19
03573026362843VITEK® MS FABIOMERIEUX SAPEX2016-12-19
03573026359119VITEK® MSBIOMERIEUX SAPEX2016-11-09
00841594110047BD Bruker MBT smart CA SystemBruker Scientific LLCPEX2016-09-21
00841594110054US IVD 48 Spot TargetBruker Scientific LLCPEX2016-09-16
00841594100024MALDI Biotyper CA SystemBruker Scientific LLCPEX2016-09-16
00841594100031MALDI Biotyper - smart CABruker Scientific LLCPEX2016-09-16