# K043208: Liquid Assayed Multiqual Control

- Pathway: 510(k) (Traditional)
- Applicant: Bio-Rad
- Decided: Jan 7, 2005 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: 2 generations back to K923633 (1992). 2 ancestors in all.
4 later devices descend from it; 2 cite it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K011867: Liquid Assayed Multiqual Control LEVEL1 #981600; Level 2 #981700; Level 3 #981800, Bio-Rad (2001) Summary page 1.

## Most influential descendants
- K100727: Liquid Assayed Multiqual 1, Liquid Assayed Multiqual 2, Liquid Assayed Multiqual 3, Liquid Assayed Multiqual Minipak (2010), 2 descendants of its own
- K130162: Liquid Assayed Multiqual Premium (2013), 1 descendant of its own
- K140971: Liquid Assayed Chemistry Control Premium Plus Level 1,2 and Level 3. (2014), 0 descendants of its own
- K132751: Multichem S Plus / S Plus (Assayed) (2013), 0 descendants of its own

## Indications for use
Liquid Assayed Multiqual 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/K043208
Methodology: https://510kreport.com/methodology