# K011579: Lyphochek Tumor Marker Control, Levels 1 and 2, 2ML, Model 580

- Pathway: 510(k) (Traditional)
- Applicant: Bio-Rad
- Decided: Jun 26, 2001 after 35 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: 3 generations back to K940433 (1994). 3 ancestors in all.
6 later devices descend from it; 3 cite it directly.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K992172: Lyphochek Tumor Marker Control, Model 580, Bio-Rad (1999) Summary page 1.

## Most influential descendants
- K071675: Liquichek Tumor Marker Control (2007), 2 descendants of its own
- K082036: Lyphochek Tumor Market Plus Control Level 1, 2 and 3 and Minipak (2008), 1 descendant of its own
- K163015: Liquichek Tumor Marker Control-Level 1; Liquichek Tumor Marker Control-Level 2; Liquichek Tumor Marker Control-Level 3; Liquichek Tumor Marker Control- Trilevel MiniPak (2017), 0 descendants of its own
- K141073: Liquichek Tumor Marker Control (2014), 0 descendants of its own
- K101809: Fujirebio Diagnostics Tumor Marker Control Model 108-20 (2010), 0 descendants of its own

## Indications for use
An assayed quality control serum to monitor the precision of laboratory testing procedures for analytes listed in the package insert.

Source page: https://510kreport.com/device/K011579
Methodology: https://510kreport.com/methodology