# K173857: Elecsys Tacrolimus

- Pathway: 510(k) (Traditional)
- Applicant: Roche Diagnostics
- Decided: Nov 6, 2018 after 321 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 4.

## Indications for use
Immunoassay for the in vitro quantitative determination of tacrolimus in EDTA human whole blood. The assay is used as an aid in the management of liver and kidney transplant patients receiving tacrolimus therapy. The electrochemiluminescence immunoassay “ECLIA” is intended for use on cobas e immunoassay analyzers.

Source page: https://510kreport.com/device/K173857
Methodology: https://510kreport.com/methodology