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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Note: this medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original PMA or panel track supplement and may not represent the most recent labeling.
 
DeviceELECSYS ANTI-HCV II IMMUNOASSAY, ELECSYS PRECICONTROL ANTI-HCV
Generic NameAssay, enzyme linked immunosorbent, hepatitis c virus
ApplicantROCHE DIAGNOSTICS OPERATIONS INC
9115 HAGUE ROAD
P.O. BOX 50416
INDIANAPOLIS, IN 46250-0416
PMA NumberP140021
Date Received10/01/2014
Decision Date06/11/2015
Reclassified Date 12/22/2021
Product Code MZO 
Docket Number 15M-2217
Notice Date 07/10/2015
Advisory Committee Microbiology
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR THE ELECSYS ANTI-HCV II IMMUNOASSAY AND ELECSYS PRECICONTROL ANTI-HCV. THIS DEVICE IS INDICATED FOR: ELECSYS ANTI-HCV II IMMUNOASSAYIMMUNOASSAY FOR THE IN VITRO QUALITATIVE DETECTION OF ANTIBODIES TO HEPATITIS C VIRUS (HCV) IN HUMAN ADULT AND PEDIATRIC (AGES 18 MONTHS THROUGH 21 YEARS) SERUM AND PLASMA (POTASSIUM EDTA, LITHIUM HEPARIN, SODIUM HEPARIN, AND SODIUM CITRATE). ASSAY RESULTS, IN CONJUNCTION WITH OTHER LABORATORY RESULTS AND CLINICAL INFORMATION, MAY BE USED TO AID IN THE PRESUMPTIVE DIAGNOSIS OF HCV INFECTION IN PERSONS WITH SIGNS AND SYMPTOMS OF HEPATITIS AND IN PERSONS AT RISK FOR HEPATITIS C INFECTION. THE TEST DOES NOT DETERMINE THE STATE OF INFECTION OR ASSOCIATED DISEASE.THE ELECTROLUMINESCENCE IMMUNOASSAY ECLIA IS INTENDED FOR USE ON THE ROCHE COBAS E 601 IMMUNOASSAY ANALYZER.ELECSYS PRECICONTROL ANTI-HCV ELECSYS PRECICONTROL ANTI-HCV IS USED FOR QUALITY CONTROL OF THE ELECSYS ANTI-HCV IMMUNOASSAY ON THE COBAS E 601 AND COBAS E 602 IMMUNOASSAY ANALYZERS AND THE ELECSYS ANTI-HCV II IMMUNOASSAY ON THE COBAS E 601 IMMUNOASSAY ANALYZER.
Approval OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
Supplements:  S001 S002 S003 S004 S005 S006 S007 S008 S009 S010 S011 
S012 S013 S014 S015 S016 
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