# K022041: Lyphochek Whole Blood Control, Models 561, 562, 563

- Pathway: 510(k) (Traditional)
- Applicant: Bio-Rad Laboratories, Inc.
- Decided: Jul 16, 2002 after 22 days
- Product code: JJY (Multi-Analyte Controls, All Kinds (Assayed))
- Device class: 1
- Regulation: 21 CFR 862.1660
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K895905 (1990). 2 ancestors in all.
6 later devices descend from it; 4 cite it directly.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K980871: Lyphochek Whole Blood Control, Bio-Rad (1998) Summary page 1.

## Most influential descendants
- K072721: Lyphochek Whole Blood Immunosuppressant Control , Abbott Immunosuppressant MCC (2007), 2 descendants of its own
- K132174: Multichem WBT (2013), 0 descendants of its own
- K080459: Chromesytems Toxicology Calibrators and Controls (2009), 0 descendants of its own
- K051074: Mas Immunosuppressant Controls (2005), 0 descendants of its own
- K042324: Lyphochek Elevated Immunosuppressant Control, Level 4, 5 (2004), 0 descendants of its own

## Indications for use
LyphochekQ Whole Blood 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.

Source page: https://510kreport.com/device/K022041
Methodology: https://510kreport.com/methodology