510(k) · Cleared
ClearedEurotrol Gas-Ise HCT QC and Eurotrol Gas-Ise HCT LVM
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Eurotrol B.V. · JJY Multi-Analyte Controls, All Kinds (Assayed)
Cleared on Jul 26, 2013 as substantially equivalent to K032453 (Bionostics, Inc., 2003) after a 53-day review. Its family tree reaches back 2 generations to 1991.
- Decided
- Jul 26, 2013
- Review
- 53 days
- Class
- Class I
- Product code
- JJY
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K913133 (1991). No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K913133 | Chality Control Material (Assayed & Unassayed) | Bionostics, Inc. | 1991 | — |
| −1 | K032453 | Roche Combitrol and Autotrol Plus B Multi Analyte Control | Bionostics, Inc. | 2003 | — |
| 0 (this device) | K131595 | Eurotrol Gas-Ise HCT QC and Eurotrol Gas-Ise HCT LVM | Eurotrol B.V. | 2013 | — |
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 JJY? 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? (1)
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 |
|---|---|---|---|
| * | K032453 | Roche Combitrol and Autotrol Plus B Multi Analyte ControlSummary page 1…-analyte controls, all kinds (assayed) (21 CFR 862.1660) 5. Predicate Device Device Name: Roche Combitrol Plus 8, Manufacturer: Bionostics, Inc., 510(k) number: k032453, Decision Date: 08/28/2003 6. Intended Use Eurotrol GAS-ISE Hct 00 Eurotrol GAS-ISE Hct QC is an assayed aqueous quality… | 2003 |
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.
What does this lineage say?
- The line of descent spans 22 years and passes through 2 companies; a new generation was cleared every 11.9 years on median.
- None of the 2 ancestors has a recall.
- 3 other devices also cite its predicate K032453.
How does its category compare?
All JJY devicesJJY Multi-Analyte Controls, All Kinds (Assayed): FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, this device’s year, is highlighted.
FDA decisions per year · JJY
3in 2017
2026 to Oct 25, outlined.
Median 510(k) review, days · JJY
78in 2017
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · JJY
2in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JJY
13in 2025
MAUDE reports naming product code JJY, 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 | 11 | 49 | 5 | 2 |
| 2008 | 7 | 54 | 0 | 1 |
| 2009 | 8 | 80 | 2 | 3 |
| 2010 | 10 | 109 | 6 | 3 |
| 2011 | 14 | 120 | 1 | 6 |
| 2012 | 13 | 40 | 3 | 20 |
| 2013 | 16 | 82 | 2 | 5 |
| 2014 | 10 | 49 | 2 | 4 |
| 2015 | 4 | 153 | 1 | 4 |
| 2016 | 1 | — | 3 | 13 |
| 2017 | 3 | 78 | 4 | 12 |
| 2018 | 0 | — | 3 | 7 |
| 2019 | 0 | — | 4 | 1 |
| 2020 | 0 | — | 6 | 7 |
| 2021 | 0 | — | 0 | 1 |
| 2022 | 0 | — | 3 | 0 |
| 2023 | 0 | — | 3 | 4 |
| 2024 | 0 | — | 0 | 1 |
| 2025 | 0 | — | 2 | 13 |
| 2026 | 0 | — | 1 | — |
What is it indicated for?
Eurotrol GAS-ISE Hot QC Eurotrol GAS-ISE Hot CC is an assayed aqueous quality control material for professional use in the verification of the precision and accuracy of the Abbott i-STAT® POCT analyzer. It is intended that Eurotrol GAS-ISE Not 00 should be used in the periodic verification of the precision and accuracy of the Abbott i-STAT POCT analyzer when measuring: pH. p02' pC02, Na+, K+, Ca++, Cl-, Glucose, Lactate, Urea, Creatinine, TC02 and…
Read the full statement (170 words)
Eurotrol GAS-ISE Hot QC
Eurotrol GAS-ISE Hot CC is an assayed aqueous quality control material for professional use in the verification of the precision and accuracy of the Abbott i-STAT® POCT analyzer.
It is intended that Eurotrol GAS-ISE Not 00 should be used in the periodic verification of the precision and accuracy of the Abbott i-STAT POCT analyzer when measuring: pH. p02' pC02, Na+, K+, Ca++, Cl-, Glucose, Lactate, Urea, Creatinine, TC02 and Hematocrit.
Eurotrol GAS-ISE Hot CC is for in vitro diagnostic use only.
Eurotrol GAS-ISE Hot LVM
Eurotrol GAS-ISE Hot LVM is an assayed aqueous blood gas, electrolyte and metabolite control material for professional use suitable for calibration verification of the Abbott i-STAT® POCT analyzer.
It is intended that Eurotrol GAS-ISE Hct LVM should be used in the periodic verification of the precision and accuracy of the Abbott i-STAT POCT analyzer when measuring: pH, p02, p002. Na+, K+, Ca++, Cl-, Glucose, Lactate, Urea, Creatinine, TC02 and Hematocrit.
Eurotrol GAS-ISE Hot LVM is for in vitro diagnostic use only.
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/K131595 · printed Nov 6, 2026
Cite this page
510(k) Report. “K131595: Eurotrol Gas-Ise HCT QC and Eurotrol Gas-Ise HCT LVM.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K131595
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026