# K050206: Cedia Tacrolimus Assay

- Pathway: 510(k) (Traditional)
- Applicant: Microgenics Corp.
- Decided: Mar 15, 2005 after 46 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
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. The FDA summary names its predicate without a number.
- (no number) IMx® Tacrolimus II (MEIA): named in the summary without a submission number

## Indications for use
The CEDIA® Tacrolimus Assay is an in vitro diagnostic device intended for use with automated clinical chemistry analyzers for the quantitative determination of tacrolimus in human whole blood as an aid in the management of kidney and liver transplant recipients receiving tacrolimus therapy. CEDIA® Tacrolimus Calibrators are intended for calibration of the CEDIA® Tacrolimus Assay in whole blood.

Source page: https://510kreport.com/device/K050206
Methodology: https://510kreport.com/methodology