# K031608: Randox Liquid Protein Calibrator

- Pathway: 510(k) (Traditional)
- Applicant: Randox Laboratories, Ltd.
- Decided: Aug 8, 2003 after 78 days
- Product code: JIX (Calibrator, Multi-Analyte Mixture)
- Device class: 2
- Regulation: 21 CFR 862.1150
- Recalls of this device: 1 (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
- K103701: Advia Chemistry Liquid Specific Protein Calibrators (2011), 0 descendants of its own

## Recalls of this device
- Nov 19, 2018 · Class II · Z-0660-2019: Calibrator value sheets have been modified for assigned value of Alpha-1-Acid-Glycoprotein (AGP), IgA and IgG to improve the alignment. IgG measurement reference has also been corrected.

## Indications for use
The Randox Laboratories Limited Liquid Protein Calibrators (for neat sample assays) are liquid calibrators derived from normal human serum obtained from volunteer donors. They have been developed for the calibration of ASO, Complement C3, Complement C4, CRP, Ferritin, IgA, IgG, IgM, Prealbumin and Transferrin assays (all neat sample assays). Assignment was performed at Randox Laboratories by immunoturbidimetry with reference to material standardised against appropriate International Reference Preparations. The constituent concentrations of these Calibrators are present at levels 0, 1, 2, 3, 4 and 5. These calibrators also contain a-1-Antitrypsin (AAT) and Rheumatoid Factor (RF) for use in the calibration of AAT and RF assays on the Bayer Advia 1650 analyser only. The Randox Laboratories Limited Liquid Protein Calibrators (for diluted sample assays) are liquid calibrators derived from normal human serum obtained from volunteer donors. They have been developed for the calibration of a-1-antitrypsin, a-1-acid glycoprotein, IgA, IgG, IgM and Transferrin assays which require sample pre-dilution. Assignment was performed at Randox Laboratories by immunoturbidimetry with reference to material standardised against appropriate International Reference Preparations. The constituent concentrations of these calibrators are present at levels 1, 2, 3, 4 and 5. The Randox Laboratories Limited Liquid Protein Calibrators, should only be used by suitably qualified laboratory personnel under appropriate laboratory conditions.

Source page: https://510kreport.com/device/K031608
Methodology: https://510kreport.com/methodology