# K203833: Tacrolimus Assay Kit

- Pathway: 510(k) (Traditional)
- Applicant: Shanghai Genext Medical Technology Co., Ltd.
- Decided: Jan 27, 2023 after 758 days
- Product code: MLM (Enzyme Immunoassay, Tracrolimus)
- Device class: 2
- Regulation: 21 CFR 862.1678
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to P970007 (1997). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K070820: Architect Tacrolimus: Model 1L77, Fujirebio Diagnostics,Inc. (2007) Summary page 5.

## Indications for use
The Tacrolimus Assay Kit is used for quantitative determination of the tacrolimus concentration in human whole blood on the Beckman Coulter AU480. It is to be used as an aid in the management of liver and kidney allograft patients receiving tacrolimus therapy. For In Vitro Diagnostic Use.

Source page: https://510kreport.com/device/K203833
Methodology: https://510kreport.com/methodology