# K023483: Kalazar Detect

- Pathway: 510(k) (Traditional)
- Applicant: Inbios Intl., Inc.
- Decided: May 6, 2003 after 201 days
- Product code: LOO (Reagent, Leishmanii Serological)
- 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 Kalazar DetectTMTest is a rapid immuno-chromatographic strip assay for the qualitative detection of antibodies to members of L. donovani complex in human serum. This test is intended for laboratory or professional in vitro diagnostic use only.

Source page: https://510kreport.com/device/K023483
Methodology: https://510kreport.com/methodology