# K033061: Calibrating Material, Ise Electrolyte Reference

- Pathway: 510(k) (Traditional)
- Applicant: Diamond Diagnostics, Inc.
- Decided: Nov 7, 2003 after 39 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: 1 generation back to K864236 (1986). 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)
- K942676: Synchron CX3 Delta, Beckman-Diagnostic Systems Group (1994) Summary page 1.
- K864236: Synchron CX3, Beckman Instruments, Inc. (1986) Summary page 1.

## Indications for use
The three products encompassed by this request are intended for in-vitro diagnostics use. Mission Electrolyte Reference Reagent provides reference points for Na, K, CI, Ca (on Delta’s only) and TC02. When used in conjunction with C02 Acid Reagent, COSAlkaline Buffer and Electrolyte Buffer, the ISE Electrolyte Reference is used for the calibration of the ISE electrodes; sodium, potassium chloride and calcium (on Delta’s only) and C02. The C02 Acid reagent is used to release C02 from samples The C02 Alkaline in used to provide a constant C02 concentration as reference for the C02 electrode. Mission reagents are intended to serve as direct replacements to the predicate devices manufactured by the OEM. The products encompassed are to be handled using normal laboratory precautions.

Source page: https://510kreport.com/device/K033061
Methodology: https://510kreport.com/methodology