# K060371: The Emit 2000 Tacrolimus Calibrators

- Pathway: 510(k) (Traditional)
- Applicant: Dade Behring, Inc.
- Decided: Mar 9, 2006 after 24 days
- Product code: JIT (Calibrator, Secondary)
- Device class: 2
- Regulation: 21 CFR 862.1150
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to P970007 (1997). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- P970007: Imx Tacrolimus II Assay, Abbott Laboratories (1997) Summary page 1.

## Indications for use
The Emit® 2000 Tacrolimus Calibrators are intended for use as a reference in measuring tacrolimus in human whole blood using the Emit® 2000 Tacrolimus Assay.

Source page: https://510kreport.com/device/K060371
Methodology: https://510kreport.com/methodology