PMA · Approved
Recalled · 2005HA-Igmk and Eti-HA-Igmk
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
DiaSorin, Inc. · LOL Hepatitis A Test (Antibody And Igm Antibody)
Approved on Jul 24, 1990 through premarket approval, which rests on the device’s own clinical evidence after a 501-day review. 7 later devices descend from it. It has been recalled once.
- Decided
- Jul 24, 1990
- Review
- 501 days
- Class
- Class II
- Product code
- LOL
- Recalls
- 1
7 later devices descend from it, 3 citing it directly.
- This deviceP890014 HA-Igmk and Eti-HA-IgmkDiaSorin, Inc. · 1990
- Descendant · cites it directly · 3 of its ownK082050 Liaison Hav Igm Assay, Liaison Control Hav IgmDiaSorin, Inc. · 2008
- Descendant · 2 generations on · 2 of its ownK103529 Liaison XL Analyzer Model 10050DiaSorin, Inc. · 2011
- Descendant · 3 generations on · 1 of its ownK141116 Liaison XL AnalyzerDiaSorin, Inc. · 2014
- Descendant · cites it directly · 1 of its ownK063319 Monolisa Anti-Hav Igm EiaBio-Rad Laboratories · 2007
- Descendant · 4 generations on · 0 of its ownK260770 LIAISON Murex HBsAg Qual; LIAISON XL; LIAISON diluteXDiaSorin, Inc. · 2026
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K082050Liaison Hav Igm Assay, Liaison Control Hav IgmDiaSorin, Inc. · 2008 · cites it directly3descendants
- K103529Liaison XL Analyzer Model 10050DiaSorin, Inc. · 2011 · 2 generations on2descendants
- K141116Liaison XL AnalyzerDiaSorin, Inc. · 2014 · 3 generations on1descendant
- K063319Monolisa Anti-Hav Igm EiaBio-Rad Laboratories · 2007 · cites it directly1descendant
- K260770LIAISON Murex HBsAg Qual; LIAISON XL; LIAISON diluteXDiaSorin, Inc. · 2026 · 4 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | P890014 | HA-Igmk and Eti-HA-Igmk | DiaSorin, Inc. | 1990 | — |
| +1 | K082050 | Liaison Hav Igm Assay, Liaison Control Hav Igm | DiaSorin, Inc. | 2008 | — |
| +2 | K103529 | Liaison XL Analyzer Model 10050 | DiaSorin, Inc. | 2011 | — |
| +3 | K141116 | Liaison XL Analyzer | DiaSorin, Inc. | 2014 | — |
| +1 | K063319 | Monolisa Anti-Hav Igm Eia | Bio-Rad Laboratories | 2007 | — |
| +4 | K260770 | LIAISON Murex HBsAg Qual; LIAISON XL; LIAISON diluteX | DiaSorin, Inc. | 2026 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2011 | 1 | 0 |
| 2014 | 1 | 0 |
| 2016 | 1 | 0 |
| 2026 | 1 | 0 |
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 LOL? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new LOL device
- #1 K251995 Access anti-HAV IgMscore 13.7 · 1 generation · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
Does it have a predicate?
PMA decisions do not claim a predicate device.
What descends from it? (7)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Apr 8, 2005 | Not classified | Z-0776-05 | Other | The package insert for Hepatitis A Virus IgM antibody kit (ETI-IgMK Plus, catalog P001925), may inadvertently contain pages 5 through 12 from the instructions for Hepatitus A virus Total antibody test (ETI-AB-HAVK Plus, catalog P001926). |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K082050 (DiaSorin, Inc., 2008) has gone furthest, with 3 descendants of its own.
How does its category compare?
All LOL devicesLOL Hepatitis A Test (Antibody And Igm Antibody): FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · LOL
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · LOL
108in 2008
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LOL
2in 2019
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LOL
19in 2025
MAUDE reports naming product code LOL, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 3 | 182 | 2 | 2 |
| 2008 | 3 | 108 | 1 | 13 |
| 2009 | 2 | — | 1 | 24 |
| 2010 | 2 | — | 0 | 53 |
| 2011 | 1 | — | 1 | 353 |
| 2012 | 1 | — | 0 | 42 |
| 2013 | 0 | — | 0 | 49 |
| 2014 | 2 | — | 0 | 19 |
| 2015 | 0 | — | 0 | 29 |
| 2016 | 2 | — | 0 | 36 |
| 2017 | 0 | — | 0 | 26 |
| 2018 | 0 | — | 1 | 61 |
| 2019 | 1 | — | 2 | 51 |
| 2020 | 1 | — | 0 | 104 |
| 2021 | 1 | — | 0 | 12 |
| 2022 | 1 | — | 0 | 17 |
| 2023 | 1 | — | 0 | 36 |
| 2024 | 0 | — | 0 | 21 |
| 2025 | 1 | — | 0 | 19 |
| 2026 | 2 | — | 0 | — |
https://510kreport.com/device/P890014 · printed Nov 6, 2026
Cite this page
510(k) Report. “P890014: HA-Igmk and Eti-HA-Igmk.” Lineage record from FDA PMA data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/P890014
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026