# K110534: Randox Liquid Cardiac Control Levels 1, 2 and 3

- Pathway: 510(k) (Traditional)
- Applicant: Randox Laboratories Limited
- Decided: Jan 23, 2012 after 332 days
- Product code: JJY (Multi-Analyte Controls, All Kinds (Assayed))
- Device class: 1
- Regulation: 21 CFR 862.1660
- Recalls of this device: 11 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Recalls of this device
- Oct 4, 2019 · Class II · Z-0412-2020: Removal of claims for N-proBNP in the Liquid Cardiac Control model numbers CQ5051 due to an observed decrease in recovery for N-Terminal Pro-Brain Natriuretic Peptide (NT-proBNP) in recent lots.
- Oct 4, 2019 · Class II · Z-0414-2020: Removal of claims for N-proBNP in the Liquid Cardiac Control catalogue number CQ5053 due to an observed decrease in recovery for N-Terminal Pro-Brain Natriuretic Peptide (NT-proBNP) in recent lots.
- Oct 4, 2019 · Class II · Z-0413-2020: Removal of claims for N-proBNP in the Liquid Cardiac Control catalogue number CQ5052 due to an observed decrease in recovery for N-Terminal Pro-Brain Natriuretic Peptide (NT-proBNP) in recent lots.
- Mar 15, 2019 · Class II · Z-1461-2020: The form received three complaints related to the user obtaining a result that fell below the target range for CK-MB provided in the RAMP Cardiac Controls Instructions for Use. Via in-house monitoring
- Mar 11, 2019 · Class II · Z-1785-2019: Customers may observe a decrease in recovered concentration with regards to NTproBNP in the Liquid Cardiac Control lots identified, on the Siemens Dimension EXL LOCI.
- Oct 2, 2018 · Class II · Z-0380-2019: Randox has previously issued a recall for Liquid Cardiac Control CQ5053 lot 4245CK under REC334 on June 8, 2018. The firm has now confirmed the Liquid Cardiac Controls CQ5051, CQ5052 and CQ5053 are no
- Oct 2, 2018 · Class II · Z-0381-2019: Randox has previously issued a recall for Liquid Cardiac Control CQ5053 lot 4245CK under REC334 on June 8, 2018. The firm has now confirmed the Liquid Cardiac Controls CQ5051, CQ5052 and CQ5053 are no
- Oct 2, 2018 · Class II · Z-0382-2019: Randox has previously issued a recall for Liquid Cardiac Control CQ5053 lot 4245CK under REC334 on June 8, 2018. The firm has now confirmed the Liquid Cardiac Controls CQ5051, CQ5052 and CQ5053 are no
- Jun 8, 2018 · Class II · Z-2575-2018: The device is not suitable for the control of the Troponin T assay due to unacceptable variation between vials. The deviation in precision observed is up to 28%. IQC that is reported as out of range c
- Aug 8, 2017 · Class II · Z-0937-2018: Randox has confirmed that Troponin T and Troponin I in Liquid Cardiac quality control CQ5053 lot 4069CK does not meet the shelf-life claim in the product labelling. As the control may now fall outside
- Sep 16, 2016 · Class II · Z-0762-2017: An internal real-time stability monitoring program revealed decreased recovery of myoglobin (-20% bias) for Randox Immunoturbidimetric and Siemens Centaur Classic methods and CKMB (-21% bias) for Roch

## Indications for use
The Randox Liquid Cardiac Controls Level 1, Level 2 and Level 3 are liquid controls containing BNP, OK MB Mass. Digoxin, D-Dimer, Homacysteine, hsCRP, Myoglobin, NT-ProBNP, Troponin I and Troponin T. They have been developed far use in the quality control of BNP, OK MB Mass, Digoxin, D-Dimer. Homocysteine, hsCRP, Myoglabin, NT-ProBNP, Troponin I and Troponin T assays on various clinical chemistry and immunoassay systems. This in vitro diagnostic device is intended for prescription use only

Source page: https://510kreport.com/device/K110534
Methodology: https://510kreport.com/methodology