# K972004: Ise Reagents for Olympus AU 800/AU5200 Chemistry Systems

- Pathway: 510(k) (Traditional)
- Applicant: Alko Diagnostic Corp.
- Decided: Jun 16, 1997 after 17 days
- Product code: CGZ (Electrode, Ion-Specific, Chloride)
- Device class: 2
- Regulation: 21 CFR 862.1170
- 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) Olympus Chemistry System product AUH1011 (ISE Buffer): named in the summary without a submission number
- (no number) Olympus Chemistry System product AUH1012 (ISE Mid-Standard): named in the summary without a submission number
- (no number) Olympus Chemistry System product AUH1013 (ISE Reference Solution): named in the summary without a submission number
- (no number) Olympus Chemistry System product AUH1014 (ISE Low Serum Standard): named in the summary without a submission number
- (no number) Olympus Chemistry System product AUH1015 (ISE High Serum Standard): named in the summary without a submission number
- (no number) Olympus Chemistry System product AUH1016 (ISE High/Low Urine Standard): named in the summary without a submission number
- (no number) Olympus Chemistry System product AUH1018 (Na/K Selectivity Check Solution): 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 the quantitative determination of Na', K', and Cl°, on the Olympus Chemistry Systems. Olympus America Incorporated is the original equipment manufacturer (OEM) of the chemistry systems and of the predicate Reagents. The Olympus Chemistry Systems performs a broad array of clinical chemistry tests. The Olympus Chemistry Systems with the ISE module measures sodium (Na'), potassium (K', and chloride (Cl) by Ion Selective Electrodes. These Reagents are intended to be used with the equivalent Olympus Chemistry Systems. As such, ALKO products are intended to serve as direct replacements to like named products manufactured by Olympus. The Buffer dilutes all measured samples for the quantitative determinations in Na', K', and Cl~ in serum and urine by ISE. The Mid-Standard Solution is intended as a means of compensating for calibration drift in the quantitative determination of Na', K', and Cl in samples on the Olympus Chemistry Systems. The Reference Solution is intended to provide a stable reference potential for Na', K', and Cl~ electrodes on the Olympus Chemistry System. The Serum High/Low Standard and Urine High/Low Standard are used to calibrate the Na', K', and Cl~ electrodes of the system’s ISE module. The ISE Na/K Selectivity Check Solutions are intended for Na', K' electrode verification. The products encompassed are to be handled using normal laboratory precautions.

Source page: https://510kreport.com/device/K972004
Methodology: https://510kreport.com/methodology