# K122126: Direct LDL/HDL Cholesterol Calibrator

- Pathway: 510(k) (Traditional)
- Applicant: Randox Laboratories Limited
- Decided: Aug 14, 2012 after 27 days
- Product code: JIS (Calibrator, Primary)
- 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 K050823 (2005). 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)
- K050823: Direct HDL Cholesterol and Direct HDL/LDL Calibrator, Teco Diagnostics (2005) Summary page 2.

## Indications for use
The Randox Direct LDL/HDL Cholesterol Calibrator is intended for in vitro diagnostic use in the calibration of Randox HDL and LDL Cholesterol methods. This in vitro diagnostic device is intended for prescription use only and can only be used by professionals.

Source page: https://510kreport.com/device/K122126
Methodology: https://510kreport.com/methodology