510(k) · Cleared
ClearedSmart Leish, Model LGM1-050
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
U.S. Army Medical Research Institute of Infectious · OUZ Nucleic Amplification Assays For The Detection Of Leishmania Nucleic Acids
Cleared on May 25, 2011 as substantially equivalent to K842526 (Amico Lab, Inc., 1984) after a 1,057-day review. Its family tree reaches back 1 generation to 1984.
- Decided
- May 25, 2011
- Review
- 1,057 days
- Class
- Class I
- Product code
- OUZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K842526 (1984). No later device cites it as a predicate yet.
- Root · 1 generation backK842526 Amizyme-Leishmania SPP. Test KitAmico Lab, Inc. · 1984
- This deviceK081868 Smart Leish, Model LGM1-050U.S. Army Medical Research Institute of Infectious · 2011
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K842526 | Amizyme-Leishmania SPP. Test Kit | Amico Lab, Inc. | 1984 | — |
| 0 (this device) | K081868 | Smart Leish, Model LGM1-050 | U.S. Army Medical Research Institute of Infectious | 2011 | — |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in OUZ? 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? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K842526 | Amizyme-Leishmania SPP. Test KitSummary page 3…minutes. " SMART LEISH 510(k) Summary Substantial Equivalence Information 1. Predicate device name: Amizyme-Leishmania spp. Test Kit 2. 510k number : K842526 Comparison with predicate: Table 1. Similarities Device Aspect SMART Leish Reference Device for both the extraction process… | 1984 |
What descends from it?
No later submission names this one as a predicate yet.
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?
- Its one ancestor has no recall.
How does its category compare?
All OUZ devicesOUZ Nucleic Amplification Assays For The Detection Of Leishmania Nucleic Acids: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, this device’s year, is highlighted.
FDA decisions per year · OUZ
1in 2011
2026 to Oct 25, outlined.
Median 510(k) review, days · OUZ
Too few OUZ 510(k)s in any year since 2007 to give a median.
Recalls per year · OUZ
No recall names OUZ since 2007.
Adverse event reports per year · OUZ
No MAUDE report names OUZ 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 | 1 | — | 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 | — |
What is it indicated for?
The SMART Leish is a qualitative diagnostic real-time PCR test for the rapid detection-of Leishmania species and the identification of L. major in skin lesion scrapings and punch biopsies from individuals suspected of having cutaneous leishmaniasis. The test utilizes real-time polymerase chain reaction assay on the Cepheid SmartCycler® Il Dx to detect Leishmania species and L. major. The SMART Leish is indicated for use in patients with clinical presentations and travel history.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K081868 · printed Nov 5, 2026
Cite this page
510(k) Report. “K081868: Smart Leish, Model LGM1-050.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K081868
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026