# K142181: Randox Aldolase Calibration Serum

- Pathway: 510(k) (Traditional)
- Applicant: Randox Laboratories Limited
- Decided: Sep 18, 2014 after 41 days
- Product code: JIT (Calibrator, Secondary)
- 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
Longest line of descent: 1 generation back to K053153 (2006). 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)
- K053153: Randox Calibration Serum, Randox Laboratories, Ltd. (2006) Summary page 5.

## Indications for use
The Aldolase Calibration Serum is intended for in vitro diagnostic use in the calibration of Aldolase on the Randox RX Daytona and Beckman Coulter AU640 systems.

Source page: https://510kreport.com/device/K142181
Methodology: https://510kreport.com/methodology