# K983807: Lyphochek Tumor Marker Control, Model #580

- Pathway: 510(k) (Traditional)
- Applicant: Bio-Rad
- Decided: Dec 16, 1998 after 49 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: 1 generation back to K940433 (1994). 1 ancestor in all.
8 later devices descend from it; 1 cites 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)
- K940433: Doa Liquid Drugs of Abuse Controls Levls 2,3,& 4,G2,G3,& G4, Medical Analysis Systems, Inc. (1994) Summary page 1.

## Most influential descendants
- K992172: Lyphochek Tumor Marker Control, Model 580 (1999), 7 descendants of its own
- K011579: Lyphochek Tumor Marker Control, Levels 1 and 2, 2ML, Model 580 (2001), 6 descendants of its own
- 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

## Indications for use
Lyphochek Tumor Marker Control is intended for use as an assayed quality control serum to monitor the precision of laboratory testing procedures for the analytes listed in this package insert.

Source page: https://510kreport.com/device/K983807
Methodology: https://510kreport.com/methodology