# K982501: Electrolyte Buffer  A443-325, Electrolyte Reference Reagent A443-315, CO2 Acid Reagent A443-330, CO2 Alkaline Buffer A44

- Pathway: 510(k) (Traditional)
- Applicant: Alko Diagnostic Corp.
- Decided: Sep 1, 1998 after 43 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. The FDA summary names its predicate without a number.
- (no number) Beckman Instrument Electrolyte Buffer (443325): named in the summary without a submission number
- (no number) Beckman Instrument Electrolyte Reference Reagent (443315): named in the summary without a submission number
- (no number) Beckman Instrument CO2 Acid Reagent (443330): named in the summary without a submission number
- (no number) Beckman Instrument CO2 Alkaline Buffer (443320): named in the summary without a submission number
- (no number) Beckman Instrument Wash Concentrate (443335): named in the summary without a submission number

## Indications for use
The products encompassed by this request are intended for in vitro diagnostic use and are intended for use in the quantitative determinations of Na" K", Cl°, and CO,. Beckman Instrument is the Original Equipment Manufacturer of the Chemistry Analyzers and of the predicate Reagents. The Beckman Chemistry Analyzers perform a broad array of tests. ALKO manufactures the ISE Reagents, wherein samples are analyzed for quantitative determinations of Na', K*, Cl "and CQO, by ISE method. These Reagents are intended to be used with equivalent Beckman Chemistry Analyzers. As such, ALKO products are intended to serve as direct replacements to like named products manufactured by Beckman Instrument Inc. The Electrolyte Buffer is intended to provide constant ionic strength for measuring electrolytes in the samples. As such, it is diluted with Wash Solution and introduced into the sample and/or calibrator, for quantitative determination of Na‘, K*, Cl ~ and CO,. The Electrolyte Reference Reagent is intended to provide reference points for Na*, K*, Cl - and CO,. The CO, Acid Reagent is intended to release CO, from serum and plasma samples and/or calibrators. The CO, Alkaline Buffer is to provide a constant CO, concentration as reference for the CO, Electrode. The Wash Concentrate is intended to be diluted with de-ionized water. The prepared Wash Solution is used to wash the systems sample flow path and to dilute reagents on equivalent Beckman CX® Systems.

Source page: https://510kreport.com/device/K982501
Methodology: https://510kreport.com/methodology