# K123372: Abbott Lipid Multi Constituent Calibrator

- Pathway: 510(k) (Traditional)
- Applicant: Abbott Laboratories
- Decided: Jan 14, 2013 after 74 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
Longest line of descent: 2 generations back to K964292 (1997). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K983289: Apolipoprotein A1, Abbott Laboratories (1999) Summary page 2.

## Indications for use
Abbott Lipid Multiconstituent Calibrator is an in vitro diagnostic product intended for the calibration of Abbott Apolipoprotein A1, Apolipoprotein B, HDL-Cholesterol and LDL-Cholesterol assays on the ARCHITECT c8000 clinical chemistry analyzer.

Source page: https://510kreport.com/device/K123372
Methodology: https://510kreport.com/methodology