# K080459: Chromesytems Toxicology Calibrators and Controls

- Pathway: 510(k) (Abbreviated)
- Applicant: Chromsystems Instruments & Chemicals GmbH
- Decided: Nov 17, 2009 after 636 days
- Product code: LAS (Drug Specific Control Materials)
- Device class: 1
- Regulation: 21 CFR 862.3280
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K895905 (1990). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K072721: Lyphochek Whole Blood Immunosuppressant Control , Abbott Immunosuppressant MCC, Bio-Rad, Diagnostics Grp. (2007) Summary page 1.
- K063868: Masstrak Immunosuppressants Kit, Waters Corporation (2007) Summary page 1.

## Indications for use
The Chromsystems MassCheck Immunosuppressant Whole Blood Controls are in vitro diagnostic devices intended to verify performance of various laboratory assay systems that measure cyclosporine, tacrolimus, or sirolimus.

Source page: https://510kreport.com/device/K080459
Methodology: https://510kreport.com/methodology