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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceELECSYS ANTI-HCV IMMUNOASSAY
Generic NameAssay, enzyme linked immunosorbent, hepatitis c virus
ApplicantROCHE DIAGNOSTICS CORP.
9115 HAGUE RD.
INDIANAPOLIS, IN 46250
PMA NumberP090008
Supplement NumberS006
Date Received11/01/2011
Decision Date04/25/2012
Reclassified Date 12/22/2021
Product Code MZO 
Advisory Committee Microbiology
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR THE EXTENSION OF THE ELECSYS ANTI-HCV IMMUNOASSAY ANDPRECICONTROL ANTI-HCV IMMUNOASSAY ONTO THE COBAS E 602 IMMUNOASSAY ANALYZER. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME ELECSYS ANTI-HCV IMMUNOASSAY AND IS INDICATED FOR: ELECSYS ANTI-HCV IMMUNOASSAY - THE ELECSYS ANTI-HCV IMMUNOASSAY IS AN IN VITRO DIAGNOSTIC TEST FOR THE QUALITATIVEDETECTION OF TOTAL ANTIBODIES TO HEPATITIS C VIRUS (ANTI-HCV) IN HUMAN SERUM OR PLASMA (POTASSIUM EDTA, LITHIUM HEPARIN AND SODIUM HEPARIN). 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. THIS TEST DOES NOT DETERMINE THE STATE OF INFECTION OR ASSOCIATED DISEASE. THE ELECTROCHEMILUMINESCENCE IMMUNOASSAY "ECLIA" IS INTENDED FOR USE ON COBAS E 601 AND COBAS E 602 IMMUNOASSAY ANALYZERS.
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