Atlas FDA

Trinidad CH Vancomycin (Vanc), Trinidad CH Drug 3 Calibrator (DRUG3 CAL)

FDA 510(k) clearance K160202 · decided 2016-04-27

Clearance details

K-number
K160202
Device name
Trinidad CH Vancomycin (Vanc), Trinidad CH Drug 3 Calibrator (DRUG3 CAL)
Applicant
Siemens Healthcare Diagnostics, Inc.
Decision
Substantially Equivalent
Date received
2016-01-28
Decision date
2016-04-27
Days to decision
90 days
Clearance type
Traditional
Product code
LEH
Device class
2
Regulation number
862.3950
Medical specialty
Clinical Toxicology
Advisory committee
Clinical Toxicology
Location
Newark, DE, US
Third-party review
No
Expedited review
No

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Devices cleared under the same product code - the starting set for predicate research.

RecordFirmDate
Atellica® CH Phencyclidine (Pcp), Atellica® CH Vancomycin (Vanc) (K222439)Siemens Healthcare Diagnostics, Inc.2023-08-08
ONLINE TDM Vancomycin Gen.3 (K152245)Roche Diagnostics Operations (Rdo)2016-01-08
ARCHITECT IVANCOMYCIN (K123947)Biokit, S.A.2013-08-29
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IMMULITE 2000, IMMULITE 2500 VANCOMYCIN (K063045)Diagnostic Products Corp.2006-12-05
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QMS VANCOMYCIN (K050419)Seradyn, Inc.2005-04-01
VITROS CHEMISTRY PRODUCTS VANC REAGENT, CALIBRATOR KIT 11 AND TDM PERFORMANCE VERIFIERS I, II AND III (K043386)Ortho-Clinical Diagnostics, Inc.2005-02-07
CEDIA VANCOMYCIN ASSAY (K032811)Microgenics Corp.2003-11-24
EMIT 2000 VANCOMYCIN ASSAY (K020692)Dade Behring, Inc.2002-05-10
SYNCHRON SYSTEMS VANCOMYCIN REAGENT; SYNCHRON SYSTEMS VANCOMYCIN CALIBRATOR (K013076)Beckman Coulter, Inc.2001-12-12
VANCOMYCIN EIA ASSAY (K983280)Diagnostic Reagents, Inc.1998-11-06

Recalls involving this device

No recalls on record reference this clearance.

PMA approvals by this applicant

RecordFirmDate
IMMULITE 2000 PSA (P930027/S039)Siemens Healthcare Diagnostics, Inc.2026-07-27
IMMULITE 2000 AFP (P010007/S026)Siemens Healthcare Diagnostics, Inc.2026-07-27
Atellica IM free PSA II (fPSAII) (P250026)Siemens Healthcare Diagnostics, Inc.2026-05-11
ADVIA Centaur AFP and Atellica IM Alpha Fetoprotein (AFP) (P930036/S026)Siemens Healthcare Diagnostics, Inc.2026-05-11
IMMULITE 2000 AFP (P010007/S025)Siemens Healthcare Diagnostics, Inc.2026-04-21
IMMULITE 2000 PSA (P930027/S038)Siemens Healthcare Diagnostics, Inc.2026-04-21
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