# K011867: Liquid Assayed Multiqual Control LEVEL1 #981600; Level 2 #981700; Level 3 #981800

- Pathway: 510(k) (Traditional)
- Applicant: Bio-Rad
- Decided: Jul 12, 2001 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: 1 generation back to K923633 (1992). 1 ancestor in all.
8 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)
- K923633: Multiqual Assay Products, Ciba Corning Diagnostics Corp. (1992) Summary page 1.

## Most influential descendants
- K043208: Liquid Assayed Multiqual Control (2005), 4 descendants of its own
- 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
- K033387: Quest Diagnostics Serum Chemistry Control, Models 935 and 945 (2003), 1 descendant of its own
- K140971: Liquid Assayed Chemistry Control Premium Plus Level 1,2 and Level 3. (2014), 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/K011867
Methodology: https://510kreport.com/methodology