Atlas FDA

ADVIA Centaur Vitamin D Total (VitD)

FDA 510(k) clearance K200509 · decided 2020-05-29

Clearance details

K-number
K200509
Device name
ADVIA Centaur Vitamin D Total (VitD)
Applicant
Siemens Healthcare Diagnostics, Inc.
Decision
Substantially Equivalent
Date received
2020-03-02
Decision date
2020-05-29
Days to decision
88 days
Clearance type
Traditional
Product code
MRG
Device class
2
Regulation number
862.1825
Medical specialty
Clinical Chemistry
Advisory committee
Clinical Chemistry
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
MAGLUMI 25-OH Vitamin D, MAGLUMI X3 Fully-auto chemiluminescence immunoassay analyzer (K232587)Shenzhen New Industries Biomedical Engineering Co., Ltd.2024-04-12
ALFIS Vitamin D, ALFIS-3 Analyzer (K221817)Immunostics Inc.,2023-09-22
Access 25(OH) Vitamin D Total (K223503)Beckman Coulter, Inc.2023-01-19
Elecsys Vitamin D total III (K210901)Roche Diagnostics2021-09-01
MAGLUMI 2000 25-OH Vitamin D (K191499)Shenzhen New Industries Biomedical Engineering Co., Ltd.2019-08-01
BioPlex 2200 25-OH Vitamin D Kit (K180577)Bio-Rad Laboratories2018-06-22
Diazyme EZ Vitamin D Assay (K172992)Diazyme Laboratories2018-01-11
LOCI Total Vitamin D Total Assay, LOCI VITD CAL (K162298)Siemens Healthcare Diagnostics2017-03-16
Elecsys Vitamin D total II, Vitamin D total II CalSet, PreciControl Vitamin D total II, Vitamin D CalCheck 5 (K162840)Roche Diagnostics2017-02-08
FREND Vitamin D Test System (K162754)Nanoentek USA, Inc.2017-01-12
IDS-iSYS 25VitDs, IDS-iSYS 25VitDs Control Set (K161831)Immunodiagnostic Systems , Ltd.2016-11-15
ARCHITECT 25-OH Vitamin D 5P02, ARCHITECT 25-OH Vitamin D 5P02 Calibrators, ARCHITECT 25-OH Vitamin D 5P02 Controls (K153375)Abbott Laboratories2016-08-12

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