# K023792: Calibration Pack, Models A9100-101S and A9100-103S

- Pathway: 510(k) (Traditional)
- Applicant: Thermo Orion
- Decided: Jan 31, 2003 after 79 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 K861087 (1986). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K961458: Avl 9180 Electrolyte Analyzer, Avl Scientific Corp. (1996) Summary page 1.

## Indications for use
The products encompassed by this request are intended for in vitro diagnostic use only and are intended for use in the calibration of equivalent Roche/AVL 9100 Series Electrolyte Analyzers.

Source page: https://510kreport.com/device/K023792
Methodology: https://510kreport.com/methodology