# K121143: Liquichek Whole Blood Immunosuppressant Control Tilevel (1,2 and 3)

- Pathway: 510(k) (Traditional)
- Applicant: Bio-Rad Laboratories
- Decided: May 18, 2012 after 32 days
- Product code: DIF (Drug Mixture 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
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 summary cites one number, which could not be confirmed as its predicate (listed below).

## Cited in the summary but kept off the family tree
- K077271: Lyphochek Whole Blood Immunosuppressant Control. Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree

## Indications for use
Liquichek Whole Blood Immunosuppressant Control Is intended for use as an assayed quality control material to monitor the precision of laboratory testing procedures for the analytes listed In the package insert. The following analytes are listed in the package Insert: Sirolimus Tacrolimus Cyclosporine Everolimus

Source page: https://510kreport.com/device/K121143
Methodology: https://510kreport.com/methodology