Atlas FDA

ADVIA Centaur® Total hCG assay

FDA 510(k) clearance K200210 · decided 2021-07-13

Clearance details

K-number
K200210
Device name
ADVIA Centaur® Total hCG assay
Applicant
Siemens Healthcare Diagnostics, Inc.
Decision
Substantially Equivalent
Date received
2020-01-28
Decision date
2021-07-13
Days to decision
532 days
Clearance type
Traditional
Product code
DHA
Device class
2
Regulation number
862.1155
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
VITROS Immunodiagnostic Products Total ß-hCG II Reagent Pack (K233581)Ortho Clinical Diagnostics2024-05-08
iFlash-HCG; Chemiluminescence Immunoassay Analyzer (Model: iFlash 3000-C) (K223690)Shenzhen Yhlo Biotech Co., Ltd.2023-12-11
Alinity i Total ß-hCG Reagent Kit, GLP systems Track (K230937)Abbott Laboratories2023-06-05
Alinity i Total B-hCG Reagent Kit, Alinity c Glucose Reagent Kit, Alinity c ICT Sample Diluent, Alinity ci-series (K230790)Abbott Laboratories2023-05-19
Access Total ßhCG (5th IS) (K221990)Beckman Coulter, Inc.2022-12-27
Diazyme DZ-Lite iFlash Total beta-hCG Assay, Diazyme DZ-Lite iFlash 1800 Chemiluminescence Immunoassay Analyzer (K212221)Diazyme Laboratories, Inc.2021-12-13
Elecsys HCG STAT (K203227)Roche Diagnostics2021-08-18
MAGLUMI 2000 HCG/ß-HCG (K192547)Shenzhen New Industries Biomedical Engineering Co., Ltd.2020-01-17
Atellica IM Total hCG (ThCG) (K192790)Siemens Healthcare Diagnostics, Inc.2019-10-30
Alinity i Total ß-hCG Reagent Kit, Alinity i System (K170317)Abbott Laboratories2017-10-23
Diazyme DZ-Lite Total beta-hCG Test System (K163418)Diazyme Laboratories2017-08-18
i-STAT Total beta-hCG Test, i-STAT Total beta-hCG Controls, i-STAT Total beta-hCG Calibration Verification Materials (K133002)Abbott Point of Care, Inc.2015-04-16

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