510(k) · Cleared
ClearedIse Reagents for Olympus AU 800/AU5200 Chemistry Systems
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Alko Diagnostic Corp. · CGZ Electrode, Ion-Specific, Chloride
Cleared on Jun 16, 1997 after a 17-day review. The FDA summary names its predicate without a number.
- Decided
- Jun 16, 1997
- Review
- 17 days
- Class
- Class II
- Product code
- CGZ
- Recalls
- None
- Predicates
- 0
The FDA summary names its predicate without a number.
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in CGZ? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against? (7)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | — | Olympus Chemistry System product AUH1011 (ISE Buffer) Named without a submission number | |
| * | — | Olympus Chemistry System product AUH1012 (ISE Mid-Standard) Named without a submission number | |
| * | — | Olympus Chemistry System product AUH1013 (ISE Reference Solution) Named without a submission number | |
| * | — | Olympus Chemistry System product AUH1014 (ISE Low Serum Standard) Named without a submission number | |
| * | — | Olympus Chemistry System product AUH1015 (ISE High Serum Standard) Named without a submission number | |
| * | — | Olympus Chemistry System product AUH1016 (ISE High/Low Urine Standard) Named without a submission number | |
| * | — | Olympus Chemistry System product AUH1018 (Na/K Selectivity Check Solution) Named without a submission number |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
How does its category compare?
All CGZ devicesCGZ Electrode, Ion-Specific, Chloride: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · CGZ
1in 2018
2026 to Oct 25, outlined.
Median 510(k) review, days · CGZ
Too few CGZ 510(k)s in any year since 2007 to give a median.
Recalls per year · CGZ
2in 2019
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · CGZ
5in 2025
MAUDE reports naming product code CGZ, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 1 | — | 1 | 4 |
| 2008 | 2 | — | 1 | 0 |
| 2009 | 0 | — | 1 | 1 |
| 2010 | 0 | — | 0 | 7 |
| 2011 | 0 | — | 1 | 5 |
| 2012 | 0 | — | 0 | 30 |
| 2013 | 0 | — | 0 | 42 |
| 2014 | 0 | — | 0 | 10 |
| 2015 | 0 | — | 0 | 2 |
| 2016 | 1 | — | 0 | 1 |
| 2017 | 1 | — | 0 | 2 |
| 2018 | 1 | — | 0 | 19 |
| 2019 | 0 | — | 2 | 3 |
| 2020 | 0 | — | 0 | 3 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 5 |
| 2023 | 0 | — | 0 | 9 |
| 2024 | 0 | — | 0 | 6 |
| 2025 | 0 | — | 0 | 5 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
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')…
Read the full statement (227 words)
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.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K972004 · printed Nov 4, 2026
Cite this page
510(k) Report. “K972004: Ise Reagents for Olympus AU 800/AU5200 Chemistry Systems.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K972004
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Page last updated Nov 3, 2026