# K072721: Lyphochek Whole Blood Immunosuppressant Control , Abbott Immunosuppressant MCC

- Pathway: 510(k) (Traditional)
- Applicant: Bio-Rad, Diagnostics Grp.
- Decided: Dec 11, 2007 after 76 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
Longest line of descent: 3 generations back to K895905 (1990). 3 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K022041: Lyphochek Whole Blood Control, Models 561, 562, 563, Bio-Rad Laboratories, Inc. (2002) Summary page 1.

## Most influential descendants
- K132174: Multichem WBT (2013), 0 descendants of its own
- K080459: Chromesytems Toxicology Calibrators and Controls (2009), 0 descendants of its own

## Indications for use
Lyphochek Whole Blood Immunosuppressant Controls 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 Abbott Immunosuppressant MCC 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

Source page: https://510kreport.com/device/K072721
Methodology: https://510kreport.com/methodology