510(k) · Cleared
ClearedElectrolyte Buffer A443-325, Electrolyte Reference Reagent A443-315, CO2 Acid Reagent A443-330, CO2 Alkaline Buffer A44
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Alko Diagnostic Corp. · JIX Calibrator, Multi-Analyte Mixture
Cleared on Sep 1, 1998 after a 43-day review. The FDA summary names its predicate without a number.
- Decided
- Sep 1, 1998
- Review
- 43 days
- Class
- Class II
- Product code
- JIX
- 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 JIX? 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? (5)
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 |
|---|---|---|---|
| * | — | Beckman Instrument Electrolyte Buffer (443325) Named without a submission number | |
| * | — | Beckman Instrument Electrolyte Reference Reagent (443315) Named without a submission number | |
| * | — | Beckman Instrument CO2 Acid Reagent (443330) Named without a submission number | |
| * | — | Beckman Instrument CO2 Alkaline Buffer (443320) Named without a submission number | |
| * | — | Beckman Instrument Wash Concentrate (443335) 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 JIX devicesJIX Calibrator, Multi-Analyte Mixture: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · JIX
1in 2016
2026 to Oct 25, outlined.
Median 510(k) review, days · JIX
29in 2015
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · JIX
7in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JIX
18in 2025
MAUDE reports naming product code JIX, 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 | 6 | 53 | 2 | 140 |
| 2008 | 5 | 69 | 3 | 173 |
| 2009 | 4 | 121 | 2 | 39 |
| 2010 | 5 | 100 | 1 | 0 |
| 2011 | 7 | 77 | 2 | 9 |
| 2012 | 2 | — | 1 | 3 |
| 2013 | 4 | 50 | 0 | 24 |
| 2014 | 1 | — | 1 | 35 |
| 2015 | 3 | 29 | 0 | 4 |
| 2016 | 1 | — | 1 | 6 |
| 2017 | 0 | — | 1 | 17 |
| 2018 | 0 | — | 1 | 16 |
| 2019 | 0 | — | 1 | 12 |
| 2020 | 0 | — | 2 | 22 |
| 2021 | 0 | — | 0 | 9 |
| 2022 | 0 | — | 0 | 11 |
| 2023 | 0 | — | 7 | 13 |
| 2024 | 0 | — | 0 | 15 |
| 2025 | 0 | — | 0 | 18 |
| 2026 | 0 | — | 1 | — |
What is it indicated for?
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…
Read the full statement (231 words)
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.
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/K982501 · printed Nov 4, 2026
Cite this page
510(k) Report. “K982501: Electrolyte Buffer A443-325, Electrolyte Reference Reagent A443-315, CO2 Acid Reagent A443-330, CO2 Alkaline Buffer A44.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K982501
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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