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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 II IMMUNOASSAY
Generic NameAssay, enzyme linked immunosorbent, hepatitis c virus
Regulation Number866.3169
ApplicantRoche Diagnostics Operations, Inc.
9115 Hague Rd.
P.O. Box 50416
Indianapolis, IN 46250
PMA NumberP140021
Supplement NumberS002
Date Received12/17/2015
Decision Date04/12/2016
Reclassified Date12/22/2021
Product Code MZO 
Advisory Committee Microbiology
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval for the migration of claims from the FDA approved Elecsys Anti-HCV II Immunoassay and Elecsys PreciControl Anti-HCV on the cobas e 601 immunoassay analyzer to the cobas e 602 analyzer. The device, as modified, will be marketed under the trade name Elecsys Anti-HCV II Immunoassay and Elecsys PreciControl Anti-HCV and is indicated for: Elecsys Anti-HCV II Immunoassay: Immunoassay 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 electrochemiluminescence immunoassay “ECLIA” is intended for use on the cobas e 601 and cobas e 602 immunoassay analyzers. Elecsys PreciControl Anti-HCV: Elecsys PreciControl Anti-HCV is used for quality control of the Elecsys Anti-HCVimmunoassay on the cobas e 601 and cobas e 602 immunoassay analyzers and the Elecsys Anti-HCV II immunoassay on the cobas e 601 and cobas e 602 immunoassay analyzers.
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