510(k) · Cleared
ClearedAmizyme-Leishmania SPP. Test Kit
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Amico Lab, Inc. · LOO Reagent, Leishmanii Serological
Cleared on Aug 28, 1984 after a 61-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 1 later device descends from it.
- Decided
- Aug 28, 1984
- Review
- 61 days
- Class
- Class I
- Product code
- LOO
- Recalls
- None
- Predicates
- 0
1 later device descends from it, 1 citing it directly.
- This deviceK842526 Amizyme-Leishmania SPP. Test KitAmico Lab, Inc. · 1984
- Descendant · cites it directly · 0 of its ownK081868 Smart Leish, Model LGM1-050U.S. Army Medical Research Institute of Infectious · 2011
Most influential descendants
Showing 1 of 1 · See all- K081868Smart Leish, Model LGM1-050U.S. Army Medical Research Institute of Infectious · 2011 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K842526 | Amizyme-Leishmania SPP. Test Kit | Amico Lab, Inc. | 1984 | — |
| +1 | K081868 | Smart Leish, Model LGM1-050 | U.S. Army Medical Research Institute of Infectious | 2011 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in LOO? 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
What was it cleared against?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K081868 | Smart Leish, Model LGM1-050 | 2011 | 0 |
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K081868 (U.S. Army Medical Research Institute of Infectious, 2011) has gone furthest, with 0 descendants of its own.
How does its category compare?
All LOO devicesLOO Reagent, Leishmanii Serological: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · LOO
FDA has decided no LOO device since 2007.
Median 510(k) review, days · LOO
Too few LOO 510(k)s in any year since 2007 to give a median.
Recalls per year · LOO
No recall names LOO since 2007.
Adverse event reports per year · LOO
No MAUDE report names LOO since 2007.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
https://510kreport.com/device/K842526 · printed Nov 6, 2026
Cite this page
510(k) Report. “K842526: Amizyme-Leishmania SPP. Test Kit.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K842526
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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