# K081868: Smart Leish, Model LGM1-050

- Pathway: 510(k) (Traditional)
- Applicant: U.S. Army Medical Research Institute of Infectious
- Decided: May 25, 2011 after 1,057 days
- Product code: OUZ (Nucleic Amplification Assays For The Detection Of Leishmania Nucleic Acids)
- Device class: 1
- Regulation: 21 CFR 866.3870
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K842526 (1984). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K842526: Amizyme-Leishmania SPP. Test Kit, Amico Lab, Inc. (1984) Summary page 3.

## Indications for use
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.

Source page: https://510kreport.com/device/K081868
Methodology: https://510kreport.com/methodology