PMA · Approved
Recalled · 2006Home Access Hepatitis C Check and Hepatitis C Check Express
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Pwn Health Chicago, LLC · QRO (no longer in FDA’s product-code list)
Approved on Apr 28, 1999 through premarket approval, which rests on the device’s own clinical evidence after a 142-day review. It has been recalled once.
- Decided
- Apr 28, 1999
- Review
- 142 days
- Class
- Class III
- Product code
- QRO
- Recalls
- 1
PMA approvals rest on their own clinical evidence and do not claim a predicate, so this family tree starts here.
P980046 has 7 supplements since 2000: changes to the approved device, its labelling or its manufacturing, each approved separately.
PMA supplements approved per year
View FIG. 1 as a table
| Year | Supplements approved |
|---|---|
| 2000 | 1 |
| 2001 | 1 |
| 2002 | 1 |
| 2003 | 1 |
| 2004 | 1 |
| 2011 | 1 |
| 2015 | 1 |
Sources: FDA PMA database (decision fields and supplements), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in QRO? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
Does it have a predicate?
PMA decisions do not claim a predicate device.
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Oct 6, 2006 | Not classified | Z-0150-2007 | Other | Wrong Expiration Date; The kits were labeled with Expiration/Use By dates; that exceed the expiration dates of the sterile safety lancet component of the kit. |
No ancestor or descendant has a Class I recall.
https://510kreport.com/device/P980046 · printed Nov 6, 2026
Cite this page
510(k) Report. “P980046: Home Access Hepatitis C Check and Hepatitis C Check Express.” Lineage record from FDA PMA data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/P980046
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Record history
- FDA decision record loaded May 2, 2026
- Page last updated Nov 3, 2026