# K043108: Liquichek Specialty Immunoassay Control

- Pathway: 510(k) (Traditional)
- Applicant: Bio-Rad Laboratories, Inc.
- Decided: Dec 7, 2004 after 28 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 K891475 (1989). 2 ancestors in all.
5 later devices descend from it; 4 cite it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K981532: Lyphochek Immunoassay Plus Control, Bio-Rad (1998) Summary page 1.

## Most influential descendants
- K110641: Fujirebio Diagnostics Vitamin D Control (2011), 1 descendant of its own
- K133960: Lypochek Specialty Immunoassay Control (2014), 0 descendants of its own
- K130337: Randox Speciality Control (I) Levels 1, 2 and 3 (2013), 0 descendants of its own
- K113177: Complete D 25-OH Vitamin D Control (2012), 0 descendants of its own
- K092749: Mas and Mini-Trol PTH Control (2009), 0 descendants of its own

## Indications for use
Liquichek Specialty Immunoassay Control is intended for use as a quality control serum to monitor the precision of laboratory testing procedures listed in the package insert.

Source page: https://510kreport.com/device/K043108
Methodology: https://510kreport.com/methodology