# K131595: Eurotrol Gas-Ise HCT QC and Eurotrol Gas-Ise HCT LVM

- Pathway: 510(k) (Traditional)
- Applicant: Eurotrol B.V.
- Decided: Jul 26, 2013 after 53 days
- Product code: JJY (Multi-Analyte Controls, All Kinds (Assayed))
- Device class: 1
- Regulation: 21 CFR 862.1660
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K913133 (1991). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K032453: Roche Combitrol and Autotrol Plus B Multi Analyte Control, Bionostics, Inc. (2003) Summary page 1.

## Indications for use
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.

Source page: https://510kreport.com/device/K131595
Methodology: https://510kreport.com/methodology