# K140971: Liquid Assayed Chemistry Control Premium Plus Level 1,2 and Level 3.

- Pathway: 510(k) (Traditional)
- Applicant: Randox Laboratories Limited
- Decided: Dec 8, 2014 after 236 days
- Product code: JJY (Multi-Analyte Controls, All Kinds (Assayed))
- Device class: 1
- Regulation: 21 CFR 862.1660
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K923633 (1992). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K130162: Liquid Assayed Multiqual Premium, Bio-Rad Laboratories (2013) Summary page 5.

## Recalls of this device
- Aug 3, 2023 · Class II · Z-2609-2023: there has been a transcription error in the Instructions for Use (IFU) for the Liquid Assayed Chemistry Control Premium Plus Level 3. For Caeruloplasmin, the one and two standard deviation values prin
- Feb 18, 2020 · Class II · Z-1547-2020: The control target and range value for Sodium using the ISE indirect method has been assigned incorrectly.

## Indications for use
The Liquid Assayed Chemistry Control Premium Plus Levels 1, 2 and 3 are assayed quality control materials intended for in vitro diagnostic use in the quality control of diagnostic assays. This material can be used to monitor the accuracy or reproducibility of analytes listed in the package insert. This device is for prescription use only.

Source page: https://510kreport.com/device/K140971
Methodology: https://510kreport.com/methodology