# K132227: Liquichek Immunoassay Premium Control-Trilevel, Liquichek Immunoassay Premium Control-Level I, Liquichek Immunoassay

- Pathway: 510(k) (Traditional)
- Applicant: Bio-Rad Laboratories
- Decided: Oct 25, 2013 after 100 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 K001373 (2000). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K001373: Liquichek Immunoassay Plus Control, Model 360, 361, 362, 363, Bio-Rad (2000) Summary page 1.

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

Source page: https://510kreport.com/device/K132227
Methodology: https://510kreport.com/methodology