# K123798: Liquidchek Diabetes Control; Level 1, Level 2, Level 3, Trilevel Minipak

- Pathway: 510(k) (Traditional)
- Applicant: Bio-Rad Laboratories
- Decided: Jan 9, 2013 after 30 days
- Product code: JJX (Single (Specified) Analyte Controls (Assayed And Unassayed))
- 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 K862186 (1986). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K052838: Liquichek Diabetes Control, Level 1,2,3,4, Bio-Rad (2005) Summary page 1.

## Indications for use
Liquichek Diabetes Control is intended for use as an assayed quality control material to monitor the precision of laboratory testing procedures for the analyte listed in the package insert.

Source page: https://510kreport.com/device/K123798
Methodology: https://510kreport.com/methodology