Premarket Approval (PMA)

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.

• Device: HOME ACCESS HEPATITIS C CHECK AND HEPATITIS C CHECK EXPRESS
• Generic Name: Immunoassay for the detection of antibody to Hepatitis C Virus intended for over the counter use
• Applicant: PWNHealth Chicago LLC; 123 W 18th Street; New York, NY 10002
• PMA Number: P980046
• Date Received: 12/07/1998
• Decision Date: 04/28/1999
• Product Code: QRO
• Docket Number: 99M-2143
• Notice Date: 07/13/1999
• Advisory Committee: Microbiology
• Expedited Review Granted?: Yes
• Combination Product: No
• Recalls: CDRH 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 Order: Approval Order
• Summary: Summary of Safety and Effectiveness
• Labeling: Labeling
• Supplements: S002 S004 S005 S006 S007 S008 S009