# K140522: Randox Immunoassay Premium Plus Control Levels 1,2 and Level 3 and Immunoassay Premium Plus Tri-Level Control

- Pathway: 510(k) (Traditional)
- Applicant: Randox Laboratories Limited
- Decided: May 22, 2014 after 79 days
- Product code: JJY (Multi-Analyte Controls, All Kinds (Assayed))
- Device class: 1
- Regulation: 21 CFR 862.1660
- Recalls of this device: 5 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K040379 (2004). 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)
- K040379: Randox Immunoassay Control, Randox Laboratories, Ltd. (2004) Summary page 2.

## Recalls of this device
- May 4, 2023 · Class III · Z-2022-2023: Delay in reporting results due to Quality Controls running high outside of range. Target value and range for ACTH in Immunoassay Premium Level 3, IA2640, lot 2031EC and Immunoassay Premium Control Tri
- May 4, 2023 · Class III · Z-2021-2023: Delay in reporting results due to Quality Controls running high outside of range. Target value and range for ACTH in Immunoassay Premium Level 3, IA2640, lot 2031EC and Immunoassay Premium Control Tri
- Feb 7, 2019 · Class III · Z-1106-2019: The target value for uptake is incorrect on the value sheet for an analyzer. The target value for this analyzer is listed as 43.8%U and should be 39.4%U.
- Aug 11, 2017 · Class III · Z-0970-2018: The ACTH in Immunoassay Premium and Premium Plus quality control does not meet the quoted reconstituted stability claim in the product IFU.
- Aug 11, 2017 · Class III · Z-0969-2018: The ACTH in Immunoassay Premium and Premium Plus quality control does not meet the quoted reconstituted stability claim in the product IFU.

## Indications for use
This product is intended for in vitro diagnostic use as assayed quality control materials to monitor the accuracy and reproducibility of the analytes listed in the package insert.

Source page: https://510kreport.com/device/K140522
Methodology: https://510kreport.com/methodology