# K981532: Lyphochek Immunoassay Plus Control

- Pathway: 510(k) (Traditional)
- Applicant: Bio-Rad
- Decided: May 12, 1998 after 13 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 K891475 (1989). 1 ancestor in all.
12 later devices descend from it; 6 cite it directly.
0 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K891475: Lyphochek (R) Immunoassay Contr Serum (Human) 1,2,3, Bio-Rad (1989) Summary page 1.

## Most influential descendants
- K043108: Liquichek Specialty Immunoassay Control (2004), 5 descendants of its own
- K110641: Fujirebio Diagnostics Vitamin D Control (2011), 1 descendant of its own
- K984594: Lyphochek Maternal Serum Control, Model 220 (1999), 1 descendant of its own
- K143379: Liquichek Maternal Serum II Control (2015), 0 descendants of its own
- K133960: Lypochek Specialty Immunoassay Control (2014), 0 descendants of its own

## Indications for use
Lyphochek Immunoassay Plus 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/K981532
Methodology: https://510kreport.com/methodology