# K123977: Randox Liquid CK-MB, Randox CK-MB Calibrator

- Pathway: 510(k) (Traditional)
- Applicant: Randox Laboratories, Ltd.
- Decided: Nov 21, 2013 after 330 days
- Product code: CGS (Nad Reduction/Nadh Oxidation, Cpk Or Isoenzymes)
- Device class: 2
- Regulation: 21 CFR 862.1215
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K003158 (2000). 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)
- K003158: Roche Diagnostics CK-MB, Roche Diagnostics Corp. (2000) Summary page 2.

## Indications for use
Randox Liquid CK-MB The Randox Liquid CK-MB test system is a device intended for the quantitative in vitro determination of CK-MB concentration in serum and plasma. Measurements of CK-MB are used in the diagnosis and treatment of myocardial infarction (MI). This product is suitable for use on the RX series instruments including the RX Daytona and the RX Imola. Randox CK-MB Calibrator The Randox CK-MB calibrator is an in vitro diagnostic product intended for use in the calibration of Randox CK-MB methods The Randox Liquid CK-MB test system for the RX Imola and RX Daytona is a prescription use device intended to be used in clinical laboratories only.

Source page: https://510kreport.com/device/K123977
Methodology: https://510kreport.com/methodology