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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.
 
DeviceHOME ACCESS HEPATITIS C CHECK AND HEPATITIS C CHECK EXPRESS
Generic NameImmunoassay for the detection of antibody to Hepatitis C Virus intended for over the counter use
ApplicantPwn Health Chicago, LLC
123 W 18th St.
New York, NY 10002
PMA NumberP980046
Date Received12/07/1998
Decision Date04/28/1999
Product Code QRO 
Docket Number 99M-2143
Notice Date 07/13/1999
Advisory Committee Microbiology
Expedited Review Granted? Yes
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
RecallsCDRH Recalls
Approval Order Statement  
Approval for the Home Access(R) Hepatitis C Check(SM) and Hepatitis C Check(SM) Express. This device is indicated for home use for collection of a dried blood spot speciment by finger-stick, and is indicated for anonymous testing for antibody to hepatitis C virus (HCV) in adults, eighteen years or older, who may have been exposed to HCV through transfusion or organ transplant before 1992, who may have injected non-prescription durgs, or who were exposed to infected needles or had sexual contacts with HCV infected individuals.
Approval OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
Supplements:  S002 S004 S005 S006 S007 S008 S009 
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