Atlas FDA

ADVIA CENTAUR INACT PARATHYROID HORMONE (IPTH) ASSAY

FDA 510(k) clearance K121981 · decided 2013-03-21

Clearance details

K-number
K121981
Device name
ADVIA CENTAUR INACT PARATHYROID HORMONE (IPTH) ASSAY
Applicant
Siemens Healthcare Diagnostics
Decision
Substantially Equivalent
Date received
2012-07-06
Decision date
2013-03-21
Days to decision
258 days
Clearance type
Traditional
Product code
CEW
Device class
2
Regulation number
862.1545
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
Elecsys PTH , Elecsys PTH STAT (K231927)Roche Diagnostics2024-03-22
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Lumipulse G whole PTH (K190702)Fujirebio Diagnostics,Inc.2019-08-30
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IDS-iSYS Intact PTHN (K161158)Immunodiagnostic Systems , Ltd.2017-01-31
LIASON 1-84 PTH Assay, LIASON 1-84 PTH Control Set, LIASON 1-84 PTH Calibration Verifiers (K150879)DiaSorin, Inc.2015-06-22
ADVIA CENTAUR INTACT PARATHYROID HORMONE (IPTH) ASSAY (K133601)Siemens Healthcare Diagnostics, Inc.2014-02-05
LIAISON N-TACT PTH GEN II, CONTROL SET, CALIBRATION VERIFIERS (K132515)DiaSorin, Inc.2013-11-08
IDS-ISYS INTACT PTH (K103325)Immunodiagnostic Systems , Ltd.2012-02-03
VITROS IMMUNODIAGNOSTICS PRODUCTS INTACT PTH REAGENT PACK, VITROS IMMUNODIAGNOSTICS PRODUCTS INTACT PTH CALIBRATORS, VIT (K101921)Ortho-Clinical Diagnostics2010-10-22
ROCHE ELECSYS PTH TEST SYSTEM (K070709)Roche Diagnostics Corp.2007-07-13

Recalls involving this device

RecordFirmDate
ADVIA Centaur iPTH ReadyPack Assay 100 Tests; REF 10492368. For in vitro diagnostic use in recall (Z-1512-2013)Siemens Healthcare Diagnostics, Inc2013-06-06
ADVIA Centaur iPTH ReadyPack Assay 500 Tests; REF 10492369, 10493615, 1049361. For in vitr recall (Z-1513-2013)Siemens Healthcare Diagnostics, Inc2013-06-06

PMA approvals by this applicant

RecordFirmDate
Atellica IM Hepatitis B core IgM (aHBcM) (P030040/S024)Siemens Healthcare Diagnostics2025-10-17
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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