# K041926: HDL/LDL-Advance Calibrator, Cat. NO. SE-278

- Pathway: 510(k) (Traditional)
- Applicant: Diagnostic Chemicals, Ltd.
- Decided: Nov 23, 2004 after 127 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.
No later device cites it as a predicate yet.
0 of 1 device 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.

## Indications for use
For the quantitative determination of low and density lipoprotein fractions of cholesterol in serum. For IN VITRO diagnostic use. HDL/LDL-Advance Calibrator is used to calibrate HDL Cholesterol and LDL Cholesterol Assays in serum. HDL is high density lipoprotein and LDL is a low density lipoprotein.

Source page: https://510kreport.com/device/K041926
Methodology: https://510kreport.com/methodology