# K060385: Emit 2000 Tacrolimus Assay and Sample Pretreatment Reagent

- Pathway: 510(k) (Traditional)
- Applicant: Dade Behring, Inc.
- Decided: Apr 6, 2006 after 51 days
- Product code: MLM (Enzyme Immunoassay, Tracrolimus)
- Device class: 2
- Regulation: 21 CFR 862.1678
- Recalls of this device: 1 (0 Class I)
- 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.

## Recalls of this device
- Jun 29, 2017 · Class II · Z-1661-2018: Various assays used to measure different chemical levels in blood, urine, or cerebrospinal fluid may interfere with the drugs sulfasalazine and/or sulfapyridine causing falsely elevated or falsely dep

## Indications for use
The Emit® 2000 Tacrolimus Assay is for in vitro quantitative analysis of tacrolimus and metabolite in human whole blood as an aid in the management of tacrolimus therapy in liver and kidney transplant patients. The Emit® 2000 Tacrolimus Sample Pretreatment Reagent is an accessory reagent for use with the Emit® 2000 Tacrolimus Assay.

Source page: https://510kreport.com/device/K060385
Methodology: https://510kreport.com/methodology