# K980871: Lyphochek Whole Blood Control

- Pathway: 510(k) (Traditional)
- Applicant: Bio-Rad
- Decided: Apr 6, 1998 after 46 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: 1 generation back to K895905 (1990). 1 ancestor in all.
9 later devices descend from it; 2 cite it directly.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K895905: Lyphochek Whole Blood Control (Human) Levels 1,2,3, Bio-Rad (1990) Summary page 1.

## Most influential descendants
- K022041: Lyphochek Whole Blood Control, Models 561, 562, 563 (2002), 6 descendants of its own
- K072721: Lyphochek Whole Blood Immunosuppressant Control , Abbott Immunosuppressant MCC (2007), 2 descendants of its own
- K984477: Lyphochek Whole Blood Metals Control Levels 1,2,3, Models 527, 528, 529 (1999), 1 descendant of its own
- 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 Control is intended for use as an assayed quality control material to monitor the precision of laboratory testing procedures for the analytes listed in this package insert.

Source page: https://510kreport.com/device/K980871
Methodology: https://510kreport.com/methodology