HOME ACCESS HEPATITIS C CHECK
FDA premarket approval P980046/S009 · decided 2015-12-09
Approval details
- PMA number
- P980046
- Supplement
- S009
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- HOME ACCESS HEPATITIS C CHECK
- Generic name
- Assay, enzyme linked immunosorbent, hepatitis c virus
- Applicant
- Pwn Health Chicago, LLC
- Date received
- 2015-09-22
- Decision date
- 2015-12-09
- Days to decision
- 78 days
- Decision code
- APPR
- Product code
- MZO
- Advisory committee
- Microbiology
- Expedited review
- No
- Location
- New York, NY
- 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 w
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