# K063868: Masstrak Immunosuppressants Kit

- Pathway: 510(k) (Traditional)
- Applicant: Waters Corporation
- Decided: May 25, 2007 after 147 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.
1 later device descends from it; 1 cites it directly.
0 of 2 devices 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) Dade Behring Emit® 2000 Tacrolimus Assay and Calibrators: named in the summary without a submission number
- (no number) Microgenics CEDIA® Tacrolimus Assay and Calibrators: named in the summary without a submission number

## Most influential descendants
- K080459: Chromesytems Toxicology Calibrators and Controls (2009), 0 descendants of its own

## Indications for use
The Waters MassTrak Immunosuppressants Kit is indicated for the quantification of the immunosuppressive drug Tacrolimus (FK506; Prograf) in liver and kidney transplant patient whole blood samples as an aid in the management of tacrolimus therapy.

Source page: https://510kreport.com/device/K063868
Methodology: https://510kreport.com/methodology