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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 Test System
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 NumberS008
Date Received03/21/2017
Decision Date08/10/2017
Reclassified Date12/22/2021
Product Code MZO 
Advisory Committee Microbiology
Supplement TypeNormal 180 Day Track
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval for 1) 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 411 immunoassay analyzer and 2) a modification to the proprietary device name.
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