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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.
 
DeviceHOME ACCESS HEPATITIS C CHECK
Generic NameAssay, enzyme linked immunosorbent, hepatitis c virus
Regulation Number866.3169
ApplicantPwn Health Chicago, LLC
123 W 18th St.
New York, NY 10002
PMA NumberP980046
Supplement NumberS009
Date Received09/22/2015
Decision Date12/09/2015
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. Removal of testing with the CHIRON® RIBA® HCV 3.0 SIA (RIBA) from the laboratory protocol; 2. Reporting of repeatedly reactive specimens as “Presumptive HCV Infection”; 3. Reporting of specimens for which antibodies to the hepatitis C virus were not found as “Negative”; 4. Home Access Hepatitis C Check had previously identified either Indeterminate or Positive as the reportable result, the communication will now be the same for both types of results: consider yourself infected with the hepatitis C virus until further testing, consult a physician of your choice and seek NAT for HCV RNA: Presumptive HCV Infection; and5. Revision of the informational brochure “Answers to Frequently Asked Questions about Hepatitis C” to exclude reference to RIBA® as part of the laboratory protocol and to modify the definition of results to reflect Presumptive HCV Infection.
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