Atlas FDA

ENZYME IMMUNOASSAY, VANCOMYCIN

FDA 510(k) clearance K060586 · decided 2006-05-11

Clearance details

K-number
K060586
Device name
ENZYME IMMUNOASSAY, VANCOMYCIN
Applicant
Roche Diagnostics Corp.
Decision
Substantially Equivalent
Date received
2006-03-07
Decision date
2006-05-11
Days to decision
65 days
Clearance type
Traditional
Product code
LEH
Device class
2
Regulation number
862.3950
Medical specialty
Clinical Toxicology
Advisory committee
Clinical Toxicology
Location
Indianapolis, IN, 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
Trinidad CH Vancomycin (Vanc), Trinidad CH Drug 3 Calibrator (DRUG3 CAL) (K160202)Siemens Healthcare Diagnostics, Inc.2016-04-27
ONLINE TDM Vancomycin Gen.3 (K152245)Roche Diagnostics Operations (Rdo)2016-01-08
ARCHITECT IVANCOMYCIN (K123947)Biokit, S.A.2013-08-29
ARCHITECT IVANCOMYCIN REAGENTS AND ARCHITECT IVANCOMYCIN CALIBRATORS, MODELS: 1P30-25 AND 1P30-01 (K072036)Biokit, S.A.2008-03-19
IMMULITE 2000, IMMULITE 2500 VANCOMYCIN (K063045)Diagnostic Products Corp.2006-12-05
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

RecordFirmDate
ONLINE TDM Vancomycin 100 tests; ONLINE TDM Vancomycin 200 tests; Hitachi Vancomycin (Modu recall (Z-2304-2016)Roche Diagnostics Operations, Inc.2016-08-01
Roche VANC2, Online TDM Vancomycin, for use with the Roche/Hitachi Cobas c 501analyzer; Ca recall (Z-0919-2007)Roche Diagnostics Corp.2007-06-09

PMA approvals by this applicant

RecordFirmDate
ELECSYS FREE PSA IMMUNOASSAY/CALSET/CALCHECK (P000027/S043)Roche Diagnostics Corp.2025-05-27
ELECSYS TOTAL PSA IMMUNOASSAY AND TOTAL PSA CALSET (P990056/S044)Roche Diagnostics Corp.2025-05-27
Elecsys Anti-HBc II (P100031/S033)Roche Diagnostics Corp.2025-05-22
Elecsys Anti-HBc II (P100032/S023)Roche Diagnostics Corp.2025-05-22
Elecsys Anti-HBc IgM (P110031/S027)Roche Diagnostics Corp.2025-05-22
Elecsys Anti-HBc IgM (P110022/S034)Roche Diagnostics Corp.2025-05-22
Elecsys Anti-HBs (P010054/S048)Roche Diagnostics Corp.2025-05-22
Elecsys Anti-HBc IgM and PreciControl Anti-HBc IgM (P110031/S025)Roche Diagnostics Corp.2024-11-22