# K140393: Randox Ammonia Ethanol Control Levels 1, 2 and Level 3

- Pathway: 510(k) (Traditional)
- Applicant: Randox Laboratories Limited
- Decided: Mar 25, 2014 after 39 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 K955024 (1995). 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)
- K123198: Liquichek Ethanol/Ammonia Control Level 1 Model 271, Liquichek Ethanol/Ammonia Control Level 2 Model 272, Liquichek Etha, Bio-Rad Laboratories (2012) Summary page 2.

## Indications for use
The Randox Ammonia Ethanol Controls Levels 1,2, & 3 are intended for in vitro diagnostic use in the quality control of Ammonia and Alcohol Assays to monitor precision and to detect systematic analytical deviations on clinical chemistry systems. This device is for prescription use only.

Source page: https://510kreport.com/device/K140393
Methodology: https://510kreport.com/methodology