Atlas FDA

ADVIA Centaur BR

FDA 510(k) clearance K193489 · decided 2020-02-13

Clearance details

K-number
K193489
Device name
ADVIA Centaur BR
Applicant
Siemens Healthcare Diagnostics, Inc.
Decision
Substantially Equivalent
Date received
2019-12-17
Decision date
2020-02-13
Days to decision
58 days
Clearance type
Traditional
Product code
MOI
Device class
2
Regulation number
866.6010
Medical specialty
Immunology
Advisory committee
Immunology
Location
Tarrytown, NY, US
Third-party review
No
Expedited review
No

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Similar devices under this product code

Devices cleared under the same product code - the starting set for predicate research.

RecordFirmDate
Access BR Monitor (K240403)Beckman Coulter, Inc.2024-05-09
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ADVIA Centaur CA 15-3 assay (K192777)Siemens Healthcare Diagnostics, Inc.2019-11-22
Elecsys CA 15-3 II (K181492)Roche Diagnostics2018-06-22
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DIMENSION VISTA LOCI CA 15-3 FLEX REAGENT CARTRIDGE, DIMENSION VISTA LOCI 7 CALIBRATOR, MODELS: K6456 AND KC605 (K100344)Siemens Healthcare Diagnostics2011-04-18
ACCESS IMMUNOASSAY SYSTEMS BR MONITOR, AND CALIBRATORS, MODEL(S) 387620,AND 387647 (K072612)Beckman Coulter, Inc.2007-10-26
ARCHITECT CA 15-3 ASSAY (K042732)Fujirebio Diagnostics,Inc.2004-12-22
BR MONITOR AND BR MONITOR CALIBRATORS ON THE ACCESS IMMUNOASSAY SYSTEMS, MODEL 387620, 387647 (K033036)Beckman Coulter, Inc.2004-02-03
CA 15-3 ASSAY FOR THE ADVIA INTEGRATED MODULAR SYSTEM (K022178)Bayer Diagnostics Corp.2002-11-12
IMMULITE BR-MA, MODEL #LKBR; IMMULITE 2000 BR-MA, MODEL #L2KBR (K013984)Diagnostic Products Corp.2002-03-28

Recalls involving this device

No recalls on record reference this clearance.

PMA approvals by this applicant

RecordFirmDate
Atellica IM Total PSA II (tPSAII) (P240021)Siemens Healthcare Diagnostics, Inc.2025-12-03
IMMULITE 2000 PSA (P930027/S037)Siemens Healthcare Diagnostics, Inc.2025-10-30
IMMULITE 2000 AFP (P010007/S024)Siemens Healthcare Diagnostics, Inc.2025-10-30
Atellica IM Anti-Hepatitis B surface Antigen 2 (aHBs2) (P100039/S018)Siemens Healthcare Diagnostics, Inc.2025-10-17
Atellica IM Anti-HBe2 (aHBe2) (P200017/S005)Siemens Healthcare Diagnostics, Inc.2025-10-17
Atellica IM HBc Total 2 (HBcT2) (P210019/S004)Siemens Healthcare Diagnostics, Inc.2025-10-17
IMMULITE 2000 Prostate-Specific Antigen (PSA) (P930027/S036)Siemens Healthcare Diagnostics, Inc.2025-08-14
ADVIA Centaur® AFP Immunoassay; Atellica IM Alpha Fetoprotein (AFP) (P930036/S025)Siemens Healthcare Diagnostics, Inc.2025-07-16