Atlas FDA

VITROS Immunodiagnostic Products Intact PTH II Reagent Pack

FDA 510(k) clearance K221197 · decided 2023-09-05

Clearance details

K-number
K221197
Device name
VITROS Immunodiagnostic Products Intact PTH II Reagent Pack
Applicant
Ortho Clinical Diagnostics
Decision
Substantially Equivalent
Date received
2022-04-25
Decision date
2023-09-05
Days to decision
498 days
Clearance type
Traditional
Product code
CEW
Device class
2
Regulation number
862.1545
Medical specialty
Clinical Chemistry
Advisory committee
Clinical Chemistry
Location
Bridgend, GB
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
Access Intact PTH (K232791)Beckman Coulter, Inc.2024-03-01
Lumipulse G whole PTH (K190702)Fujirebio Diagnostics,Inc.2019-08-30
ADVIA Centaur Intact Parathyroid Hormone (PTH) Assay (K163658)Siemens Healthcare Diagnostics, Inc.2017-05-23
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
ADVIA CENTAUR INACT PARATHYROID HORMONE (IPTH) ASSAY (K121981)Siemens Healthcare Diagnostics2013-03-21
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

No recalls on record reference this clearance.

PMA approvals by this applicant

RecordFirmDate
VITROS Immunodiagnostic Products Anti-HBe Reagent Pack and Calibrator (P100001/S017)Ortho-Clinical Diagnostics2023-01-24
VITROS Anti-HBe (P100001/S016)Ortho-Clinical Diagnostics2019-06-19
VITROS Anti-HBc (P030024/S029)Ortho-Clinical Diagnostics2019-06-19
VITROS Immunodiagnostic Products Anti-HBc Reagent Pack and Calibrator (P030024/S028)Ortho-Clinical Diagnostics2018-12-17
VITROS Immunodiagnostic Products Anti-HBe Reagent Pack and Calibrator (P100001/S015)Ortho-Clinical Diagnostics2018-12-17
VITROS Immunodiagnostic Products Anti-HBc Reagent Pack and Calibrator (P030024/S027)Ortho-Clinical Diagnostics2018-10-16
VITROS Immunodiagnostic Products Anti-HBc Reagent Pack and Calibrator (P030024/S025)Ortho-Clinical Diagnostics2018-07-02
VITROS Immunodiagnostic Products Anti-HBc Reagent Pack and Calibrator (P030024/S026)Ortho-Clinical Diagnostics2018-07-02