PMA · Approved
Recalled · 2007Havab-M Diagnostic Kit
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Abbott Laboratories · LOL Hepatitis A Test (Antibody And Igm Antibody)
Approved on Jun 10, 1980 through premarket approval, which rests on the device’s own clinical evidence after a 288-day review. 3 later devices descend from it. It has been recalled once.
- Decided
- Jun 10, 1980
- Review
- 288 days
- Class
- Class II
- Product code
- LOL
- Recalls
- 1
3 later devices descend from it, 2 citing it directly.
- This deviceP790019 Havab-M Diagnostic KitAbbott Laboratories · 1980
- Descendant · cites it directly · 1 of its ownK060770 Vitros Immunodiagnostic Products Anti-Hav Igm-Reagent Pack…Ortho-Clinical Diagnostics, Inc. · 2006
- Descendant · 2 generations on · 0 of its ownK161964 ADVIA Centaur HAV IgM AssaySiemens Healthcare Diagnostics, Inc. · 2016
- Descendant · cites it directly · 0 of its ownK093955 Anti-Hav IgmRoche Diagnostics · 2010 · Recalled
Most influential descendants
Showing 3 of 3 · See all- K060770Vitros Immunodiagnostic Products Anti-Hav Igm-Reagent Pack, Calibrator, and ControlsOrtho-Clinical Diagnostics, Inc. · 2006 · cites it directly1descendant
- K161964ADVIA Centaur HAV IgM AssaySiemens Healthcare Diagnostics, Inc. · 2016 · 2 generations on0descendants
- K093955Anti-Hav IgmRoche Diagnostics · 2010 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | P790019 | Havab-M Diagnostic Kit | Abbott Laboratories | 1980 | — |
| +1 | K060770 | Vitros Immunodiagnostic Products Anti-Hav Igm-Reagent Pack, Calibrator, and… | Ortho-Clinical Diagnostics, Inc. | 2006 | — |
| +2 | K161964 | ADVIA Centaur HAV IgM Assay | Siemens Healthcare Diagnostics, Inc. | 2016 | — |
| +1 | K093955 | Anti-Hav Igm | Roche Diagnostics | 2010 | 2 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
| 2010 | 1 | 0 |
| 2016 | 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? (3)
2 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 23, 2007 | Not classified | Z-1036-2007 | Other | Failure of the AxSYM instrument to open (actuate) some reagent packs from certain lots. The defects can result in probe crashes if not detected prior to placement of the reagent kit on the AxYM instrument. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K060770 (Ortho-Clinical Diagnostics, Inc., 2006) has gone furthest, with 1 descendant 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/P790019 · printed Nov 6, 2026
Cite this page
510(k) Report. “P790019: Havab-M Diagnostic Kit.” Lineage record from FDA PMA data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/P790019
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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