PMA P980046

Device: HOME ACCESS HEPATITIS C CHECK
Applicant: Pwn Health Chicago, LLC
PMA number: P980046
Supplement: S009
Product code: MZO
Decision date: 2015-12-09
Classification: Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus
Generic name: Assay, enzyme linked immunosorbent, hepatitis c virus
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.

Current openFDA PMA Record#

Device: HOME ACCESS HEPATITIS C CHECK
Applicant: Pwn Health Chicago, LLC
PMA number: P980046
Supplement: S009
Product code: MZO
Generic name: Assay, enzyme linked immunosorbent, hepatitis c virus
Decision date: 2015-12-09
Decision code: APPR
Date received: 2015-09-22
Supplement type: Normal 180 Day Track
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
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.