# K141341: CL Detect Rapid Test

- Pathway: 510(k) (Traditional)
- Applicant: InBios International, Inc.
- Decided: Nov 14, 2014 after 177 days
- Product code: PIT (Leishmania Spp. Antigen Detection Assay)
- 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
The CL Detect™ Rapid Test is a qualitative, in vitro immunochromatographic assay for the rapid detection of Leishmania species antigen in ulcerative skin lesions. The test is intended for use with dental broach samples from less than four month old ulcerative skin lesions that are obtained from patients with suspected cutaneous leishmaniasis (CL). The test targets the peroxidoxin antigen of Leishmania species that may cause CL. The CL DetectTM Rapid Test is intended to aid in the diagnosis of CL, and must be interpreted within the context of all relevant clinical and laboratory findings.

Source page: https://510kreport.com/device/K141341
Methodology: https://510kreport.com/methodology