PMA · Approved
Recalled · 2010Diasorin Eti-AB-Auk Plus Assay
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Approved on Mar 30, 2001 through premarket approval, which rests on the device’s own clinical evidence after a 637-day review. It has been recalled once.
- Decided
- Mar 30, 2001
- Review
- 637 days
- Class
- Class III
- Recalls
- 1
PMA approvals rest on their own clinical evidence and do not claim a predicate, so this family tree starts here.
P990042 has 26 supplements since 2002: 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 |
|---|---|
| 2002 | 5 |
| 2003 | 1 |
| 2004 | 1 |
| 2010 | 1 |
| 2011 | 2 |
| 2012 | 2 |
| 2013 | 1 |
| 2014 | 2 |
| 2016 | 1 |
| 2017 | 3 |
| 2018 | 3 |
| 2019 | 2 |
| 2020 | 1 |
| 2021 | 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 this category? 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 |
|---|---|---|---|---|
| Aug 19, 2010 | Not classified | Z-1744-2011 | Other | Through internal testing, DiaSorin has become aware that the kit lots identified (ETI-AB-AUK PLUS kits, catalog number P001931, lot numbers 0650270A and/or 0650270A/1) may not consistently exhibit stability to defined expiration dating… |
No ancestor or descendant has a Class I recall.
https://510kreport.com/device/P990042 · printed Nov 6, 2026
Cite this page
510(k) Report. “P990042: Diasorin Eti-AB-Auk Plus Assay.” Lineage record from FDA PMA data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/P990042
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Record history
- FDA decision record loaded May 2, 2026
- Page last updated Nov 3, 2026