# K981795: Cleaning Solution (1) Model Number A943-795, Salt Bridge Solution Model Number A943-794, Calibration Solution, PH 7.4 MO

- Pathway: 510(k) (Traditional)
- Applicant: Thermo Bioanalysis Corp.
- Decided: Jun 12, 1998 after 22 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) Radiometer Medical/Copenhagen Calibration Solution, pH 7.4/3 (S1565 / 943-791): named in the summary without a submission number
- (no number) Radiometer Medical/Copenhagen Calibration Solution, pH 6.8/4 (S1575 / 943-792): named in the summary without a submission number
- (no number) Radiometer Medical/Copenhagen Salt Bridge Solution /2 (S4915 / 943-794): named in the summary without a submission number
- (no number) Radiometer Medical/Copenhagen Cleaning Solution /1 (S5345 / 943-795): named in the summary without a submission number
- (no number) Radiometer Medical/Copenhagen Rinse Solution /5 (S4901 / 943-793): named in the summary without a submission number
- (no number) Radiometer Medical/Copenhagen Hypochlorite Solution (S5362 / 943-906): 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 calibrating the electrodes and cleaning / flushing the sample flow path of the equivalent ABL™ pH/Blood Gas Systems. Radiometer Medical/Copenhagen is the Original Equipment Manufacturer of the analyzers and of the predicate Reagents. The ABL™ pH/Blood Gas Analyzers perform a broad array of blood gas and co-oximetery tests. ALKO manufactures the calibration reagents for the analyzer’s analyte pH, (concentration of hydrogen ions) which is measured by glass membrane electrodes. ALKO also manufactures the Cleaning, Rinse, Hypochlorite and Salt Bridge Solution. These Reagents are intended to be used with equivalent ABL™ pH/Blood Gas Analyzers. As such, ALKO products are intended to serve as direct replacements to like named products manufactured by Radiometer Medical/Copenhagen. The Calibration Solution, pH 7.4/ 3 and Calibration Solution, pH 6.8/ 4 are intended to provide calibration points for the pH electrode on the analyzer. The Salt Bridge Solution /2 provides a liquid junction through the reference electrode during calibration and measurement. The Cleaning Solution /1, Rinse Solution /5 and Hypochlorite Solution are intended for maintenance of the analyzers electrodes and sample flow path. The products encompassed are to be handled using normal laboratory precautions.

Source page: https://510kreport.com/device/K981795
Methodology: https://510kreport.com/methodology