# K960085: Ise Calibrant a & B, Ise Liquid Reagent for Paramax Clinak Systems

- Pathway: 510(k) (Traditional)
- Applicant: Alko Diagnostic Corp.
- Decided: Mar 11, 1996 after 60 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.
2 later devices descend from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names no predicate by number.

## Most influential descendants
- K060678: Vitros Immunodiagnostic Products Anti-Hav Total Reagent Pack,Calibrator,Controls (2006), 1 descendant of its own
- K142758: ADVIA Centaur HAV total assay (2014), 0 descendants of its own

## Indications for use
The calibrators are intended for use in calibrating the electrodes of Paramax® CLiNaK™ Analyzers. The ISE Liquid Reagent is used to dilute samples measured on the Paramax® CLiNaK™ Analyzers.

Source page: https://510kreport.com/device/K960085
Methodology: https://510kreport.com/methodology