Atlas FDA

DIMENSION VISTA LOCI CA 15-3 FLEX REAGENT CARTRIDGE, DIMENSION VISTA LOCI 7 CALIBRATOR, MODELS: K6456 AND KC605

FDA 510(k) clearance K100344 · decided 2011-04-18

Clearance details

K-number
K100344
Device name
DIMENSION VISTA LOCI CA 15-3 FLEX REAGENT CARTRIDGE, DIMENSION VISTA LOCI 7 CALIBRATOR, MODELS: K6456 AND KC605
Applicant
Siemens Healthcare Diagnostics
Decision
Substantially Equivalent
Date received
2010-02-05
Decision date
2011-04-18
Days to decision
437 days
Clearance type
Traditional
Product code
MOI
Device class
2
Regulation number
866.6010
Medical specialty
Immunology
Advisory committee
Immunology
Location
Newark, DE, US
Third-party review
No
Expedited review
No

+ Add to Predicate Builder ◉ Watch Siemens Healthcare Diagnostics

The Builder collects up to 8 candidate devices side by side with yours, then exports the substantial-equivalence comparison scaffold. How it works

Need this as data, not a web page?

Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.

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
IMMULITE® 2000 BR-MA (K233946)Siemens Healthcare Diagnostics Products, Ltd.2024-03-13
Lumipulse G CA15-3 (K192524)Fujirebio Diagnostics,Inc.2020-09-04
ADVIA Centaur BR (K193489)Siemens Healthcare Diagnostics, Inc.2020-02-13
ADVIA Centaur CA 15-3 assay (K192777)Siemens Healthcare Diagnostics, Inc.2019-11-22
Elecsys CA 15-3 II (K181492)Roche Diagnostics2018-06-22
Elecsys CA 15-3 II (K171605)Roche Diagnostics2018-02-20
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

RecordFirmDate
Dimension Vista LOCI CA 15-3 Flex reagent cartridge. In Vitro Diagnostic for the quantitat recall (Z-1648-2022)Siemens Healthcare Diagnostics, Inc.2022-08-29

PMA approvals by this applicant

RecordFirmDate
Atellica IM Hepatitis B core IgM (aHBcM) (P030040/S024)Siemens Healthcare Diagnostics2025-10-17
Atellica IM Hepatitis B e Antigen (HBeAg) (P090024/S013)Siemens Healthcare Diagnostics2025-10-17
ADVIA Centaur® PSA Immunoassay; Atellica IM Prostate-Specific Antigen (PSA) (P950021/S030)Siemens Healthcare Diagnostics2025-07-16
ADVIA Centaur® Complexed PSA (cPSA) Immunoassay; Atellica IM Complexed Prostate-Specific Antigen (cPSA) (P990055/S029)Siemens Healthcare Diagnostics2025-07-16
Dimension TPSA Flex reagent cartridge (P000021/S047)Siemens Healthcare Diagnostics2025-05-22
Dimension FPSA Flex reagent cartridge (P020027/S042)Siemens Healthcare Diagnostics2025-05-22
Dimension FPSA Flex reagent cartridge (P020027/S041)Siemens Healthcare Diagnostics2025-02-24
Dimension TPSA Flex reagent cartridge (P000021/S046)Siemens Healthcare Diagnostics2025-02-24