# K023158: Randox Apolipoprotein Calibrator

- Pathway: 510(k) (Traditional)
- Applicant: Randox Laboratories, Ltd.
- Decided: Oct 24, 2002 after 31 days
- Product code: JIX (Calibrator, Multi-Analyte Mixture)
- Device class: 2
- Regulation: 21 CFR 862.1150
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
4 later devices descend from it; 1 cites it directly.
0 of 5 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
- K041870: N Apolipoprotein Standard Serum (2004), 3 descendants of its own
- K063608: Dimension Vista APOA1 and Apob Flex Reagent Cartridges and Protein 1 Calibrator and Control Medium and High (2007), 1 descendant of its own
- K181373: Extended Lipid Panel Assay (2018), 0 descendants of its own
- K042521: Vitros Chemistry Products APOA1 and Apob Reagents, Calibrator Kits 21 and 22 and APOA1 and Apob Performance Verifiers (2004), 0 descendants of its own

## Indications for use
The Randox Laboratories Limited Apolipoprotein Calibrator is based on lyophilised human serum and has been developed for use in the calibration of Apolipoprotein A-I and Apolipoprotein B assays. The constituent concentrations of the Randox Laboratories Limited Apolipoprotein Calibrator are present at 1 level. The Randox Labotatories Limited Apolipoprotein Calibrator should only be used by suitably qualified personnel, under appropriate laboratory conditions.

Source page: https://510kreport.com/device/K023158
Methodology: https://510kreport.com/methodology