# K053153: Randox Calibration Serum

- Pathway: 510(k) (Traditional)
- Applicant: Randox Laboratories, Ltd.
- Decided: Jan 13, 2006 after 64 days
- Product code: JIX (Calibrator, Multi-Analyte Mixture)
- Device class: 2
- Regulation: 21 CFR 862.1150
- Recalls of this device: 6 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices 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.

## Most influential descendants
- K142181: Randox Aldolase Calibration Serum (2014), 0 descendants of its own

## Recalls of this device
- Mar 5, 2024 · Class II · Z-1759-2024: Randox Laboratories has identified that Inorganic Phosphate in Calibration Serum Level 3, CAL2351 & CAL10388, is running with a negative bias on RX Series instruments compared to other methods.
- Nov 20, 2023 · Class II · Z-0752-2024: CK Total in Calibration Serum Level 3, CAL2351, is running with a positive bias on RX Series instruments compared to other methods experience a shift in Quality Control and patient sample recovery of 
- Nov 20, 2023 · Class II · Z-0753-2024: Target for Alkaline Phosphatase (ALP) for the AMP optimized to IFCC 37C method has been mis-assigned for the RX Series instruments by approximately 10% on Quality Control and patient samples
- Nov 13, 2023 · Class II · Z-0751-2024: There have been transcription errors on the Instructions For Use (IFU) of the Calibration Serum Level 3 (CAL2351 lot 1260UE, 1262UE and 1315UE) for target values of Bilirubin and Triglycerides, on the
- Mar 29, 2021 · Class II · Z-1563-2021: Randox can confirm a positive bias for Total Bilirubin and Direct Bilirubin of up to +15% across the assay ranges when using calibrator CAL2351, lot 1162UE. The positive bias has been attributed to bi
- Jul 12, 2019 · Class III · Z-2490-2019: Randox Laboratories realigned RX Analyser Series calibration targets by 10% for AST and 9% for ALT in line with the Mean of All Instrument method target for the Randox Calibration Serum Level 3 (for c

## Indications for use
This is an in vitro diagnostic product intended for use as a calibration serum in clinical chemistry assays. Randox calibration serum contains 43 analytes and is based on lyophilized human serum. The concentrations and activities are suitable for calibration of clinical chemistry assays both manually and on a wide range of automatic analysers. Constituent concentrations are available at 2 levels.

Source page: https://510kreport.com/device/K053153
Methodology: https://510kreport.com/methodology