(53 days)
Not Found
No
The device description details a quality control material composed of aqueous solutions and salts, designed to verify the precision and accuracy of a separate analyzer. There is no mention of any computational or algorithmic components, let alone AI or ML.
No.
This device is an in vitro diagnostic quality control material used to verify the precision and accuracy of another analyzer, not to directly treat or diagnose a disease in a patient.
No
This device is a quality control material intended to verify the precision and accuracy of another diagnostic device (the Abbott i-STAT POCT analyzer), rather than being a diagnostic device itself. It does not diagnose any condition directly.
No
The device description clearly states it is an "assayed aqueous quality control material" and a "non-hazardous aqueous solution" prepared using salts in an aqueous matrix. This indicates a physical, liquid-based product, not software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Explicit Statement: The "Intended Use / Indications for Use" section for both Eurotrol GAS-ISE Hct QC and Eurotrol GAS-ISE Hct LVM explicitly states: "Eurotrol GAS-ISE Hct QC is for in vitro diagnostic use only." and "Eurotrol GAS-ISE Hct LVM is for in vitro diagnostic use only."
- Purpose: The intended use is to verify the precision and accuracy of the Abbott i-STAT POCT analyzer when measuring various parameters (pH, pO2, pCO2, Na+, K+, Ca++, Cl-, Glucose, Lactate, Urea, Creatinine, TCO2 and Hematocrit). These parameters are measured in biological samples (blood) using the i-STAT analyzer, and the control material is used to ensure the accuracy of those measurements. This aligns with the definition of an in vitro diagnostic device, which is used to examine specimens derived from the human body to provide information for diagnostic purposes.
- Device Description: The description details the composition and preparation of the control material, which is designed to simulate clinically significant ranges of various analytes found in blood. This further supports its use in the context of in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
Eurotrol GAS-ISE Hct QC 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 Hct QC should be used in the periodic verification of the precision and accuracy of the Abbott i-STAT POCT analyzer when measuring: pH, pO2, pCO2, Na+, K+, Ca++, Cl-, Glucose, Lactate, Urea, Creatinine, TCO2 and Hematocrit. Eurotrol GAS-ISE Hot QC is for in vitro diagnostic use only.
Eurotrol GAS-ISE Hct LVM is an assayed aqueous blood gas, electrolyte and metabolite control material for professional use suitable for calibration 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, pO2, pCO2, Na+, K+, Ca++, Cl-, Glucose, Lactate, Urea, Creatinine, TCO2 and Hematocrit. Eurotrol GAS-ISE Hot LVM is for in vitro diagnostic use only.
Product codes (comma separated list FDA assigned to the subject device)
JJY
Device Description
Eurotrol GAS-ISE Hct QC quality controls are prepared using salts in an aqueous, physiologically buffered matrix. Tonometry with predetermined levels of oxygen and carbon dioxide balanced with nitrogen and different salt concentrations provides distinct levels for each parameter, simulating clinically significant ranges of acid-base and electrolyte balance, respiratory function, glucose, lactate, urea and creatinine concentrations, within the reportable range of the Abbott i-STAT POCT analyzer.
Eurotrol GAS-ISE Hct QC is a non-hazardous aqueous solution that contains no biological materials.
Eurotrol GAS-ISE Hct QC provides three (3) physiological relevant levels, each ampule containing 2.5 mL of solution.
Eurotrol GAS-ISE Hct QC is packed in a carton box containing 10 ampules of a separate level.
Eurotrol GAS-ISE Hct LVM provides five (5) physiological relevant levels, each ampule containing 2.5 mL of solution. Eurotrol GAS-ISE Hct LVM quality controls are prepared using salts in an aqueous, physiologically buffered matrix. Tonometry with predetermined levels of oxygen and carbon dioxide balanced with nitrogen and different salt concentrations provides five (5) distinct levels for each parameter, simulating clinically significant ranges of acid-base and electrolyte balance, respiratory function, glucose, lactate, urea and creatinine concentrations, within the reportable range of the Abbott i-STAT POCT analyzer.
Eurotrol GAS-ISE Hct LVM is a non-hazardous aqueous solution that contains no biological materials.
Eurotrol GAS-ISE Hct LVM provides five (5) physiological relevant levels, each ampule containing 2.5 mL of solution.
Eurotrol GAS-ISE Hct LVM is packed in a carton box containing a set of 5 ampules; one ampule of each level.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
professional use, Clinical Laboratories, Point of Care testing sites
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Real time stability studies have been performed for Eurotrol GAS-ISE Hct QC and Eurotrol GAS-ISE Hct LVM. The claimed stability is 24 months when the product is stored at 2-8°C, 10 days when the product is stored unopened at room temperature and 30 seconds after opening the ampules.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 862.1660 Quality control material (assayed and unassayed).
(a)
Identification. A quality control material (assayed and unassayed) for clinical chemistry is a device intended for medical purposes for use in a test system to estimate test precision and to detect systematic analytical deviations that may arise from reagent or analytical instrument variation. A quality control material (assayed and unassayed) may be used for proficiency testing in interlaboratory surveys. This generic type of device includes controls (assayed and unassayed) for blood gases, electrolytes, enzymes, multianalytes (all kinds), single (specified) analytes, or urinalysis controls.(b)
Classification. Class I (general controls). Except when intended for use in donor screening tests, quality control materials (assayed and unassayed) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.
0
510(k) Summary K131595
-
- This summary of the 510(k) safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR 807.92
2. Submitter
Eurotrol B.V. Keplerlaan 20 6716 BS Ede, The Netherlands T +31 318 69577 F +31 318 695770 E office@eurotrol.com
3. Submitter Contact
JUL 2 6 2013
Paul B.P. Kooiimans Regulatory Affairs manager Eurotrol B.V. Keplerlaan 20 6716 BS Ede, The Netherlands T +31 318 695777 F +31 318 695770 E pkooiimans@eurotrol.com
4. Device identification
Proprietary Name: Eurotrol GAS-ISE Hct QC and Eurotrol GAS-ISE Hct LVM Common Name: Blood gas, electrolyte and metabolite control Classification Name: Class I, reserved Product code: JJY; Multi-analyte controls, all kinds (assayed) (21 CFR 862.1660)
Predicate Device 5.
Device Name: Roche Combitrol Plus B. Manufacturer: Bionostics, Inc., 510(k) number: K032453, Decision Date: 08/28/2003
6. Intended Use
Eurotrol GAS-ISE Hot QC
Eurotrol GAS-ISE Hct QC 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 Hct QC should be used in the periodic verification of the precision and accuracy of the Abbott i-STAT POCT analyzer when measuring; pH, pO2, pCO2, Na+, K+, Ca++, Cl-, Glucose, Lactate, Urea, Creatinine, TCO2 and Hematocrit.
Eurotrol GAS-ISE Hot LVM
Eurotrol GAS-ISE Hct 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, pO2, pCO2, Na+, K+, Ca++, Cl-, Glucose, Lactate, Urea, Creatinine, TCO2 and Hematocrit.
7. Device description
Eurotrol GAS-ISE Hct QC
Eurotrol GAS-ISE Hct QC quality controls are prepared using salts in an aqueous, physiologically buffered matrix. Tonometry with predetermined levels of oxygen and carbon dioxide balanced with nitrogen and different salt concentrations provides distinct levels for each parameter, simulating clinically significant ranges of acid-base and electrolyte balance, respiratory function, glucose, lactate, urea and creatinine concentrations, within the reportable range of the Abbott i-STAT POCT analyzer.
Eurotrol GAS-ISE Hct QC is a non-hazardous aqueous solution that contains no biological materials.
Eurotrol GAS-ISE Hct QC provides three (3) physiological relevant levels, each ampule containing 2.5 mL of solution.
Eurotrol GAS-ISE Hct QC is packed in a carton box containing 10 ampules of a separate level.
1
Eurotrol GAS-ISE Hct LVM
Eurotrol GAS-ISE Hct LVM provides five (5) physiological relevant levels, each ampule containing 2.5 mL of solution. Eurotrol GAS-ISE Hct LVM quality controls are prepared using salts in an aqueous, physiologically buffered matrix. Tonometry with predetermined levels of oxygen and carbon dioxide balanced with nitrogen and different salt concentrations provides five (5) distinct levels for each parameter, simulating clinically significant ranges of acid-base and electrolyte balance, respiratory function, glucose, lactate, urea and creatinine concentrations, within the reportable range of the Abbott i-STAT POCT analyzer.
Eurotrol GAS-ISE Hct LVM is a non-hazardous aqueous solution that contains no biological materials.
Eurotrol GAS-ISE Hct LVM provides five (5) physiological relevant levels, each ampule containing 2.5 mL of solution.
Eurotrol GAS-ISE Hct LVM is packed in a carton box containing a set of 5 ampules; one ampule of each level.
8. Special Instrument Required
For an appropriate use of Eurotrol GAS-ISE Hct QC and Eurotrol GAS-ISE Hct LVM the use of the Abbott i-STAT System, including test cartridges, is required.
Predicate Device Comparison 9.
Comparison of Eurotrol GAS-ISE Het QC and Eurotrol GAS-ISE Hot LVM to the predicate device for substantial equivalence:
| New Device | Predicate Device | |
|---|---|---|
| Eurotrol GAS-ISE Hct | Roche Combitrol Plus B | |
| 510(k), date | K032453, 08/28/2003 | |
| Number of | ||
| levels | - Eurotrol GAS-ISE Hct QC: 3 |
- Eurotrol GAS-ISE Hct LVM: 5 | 3 |
| Analytes | pH, pO2, pCO2, Na+, K+, Ca++, Cl-,
Glucose, Lactate, Urea, Creatinine,
TCO2 and Hematocrit (Conductivity) | pH, blood gases, Na+, K+,
iCa++ Cl-, Li+, iMg++, Glucose,
Lactate, BUN, Creatinine, tHb,
Hb derivatives and bilirubin |
| Container | Clear glass ampules | Clear glass ampules |
| Filling
Volume | 2,5 mL | 1,7 mL |
| Color | Clear, colorless | Red |
| Storage
temperature | 2 - 8°C/35 - 46°F | 2 - 8°C/35 - 46°F |
| Indications
for Use | Verification of the precision and
accuracy of the Abbott i-STAT POCT
and cartridges. | To be used to monitor and evaluate
the analytical performance of the
Roche OMNI S for analytes listed in
the package insert. |
| Matrix/
Materials | Eurotrol GAS-ISE Hct controls are
prepared using salts in a
physiologically buffered aqueous
matrix. Tonometry with predetermined
levels of oxygen and carbon dioxide
balanced with nitrogen and different
salt concentrations provide five distinct
levels for each parameter. | Buffered, aqueous electrolyte solution
equilibrated with carbon dioxide and
oxygen gas mixture |
| Form | Liquid | Liquid |
| Open
Ampule
Stability | 30 seconds | Use immediately and only use once
after opening |
| Values | Lot specific | Lot specific |
| Shelf life | 24 months at 2-8°C
10 days at 20-25°C | 24 months at 2-8°C
3 months at room temperature |
| Where used | Clinical Laboratories, Point of Care
testing sites | Clinical Laboratories, Intensive Care
Units (ICU), Emergency Rooms (ER),
Operating rooms (OR), Remote or
STAT-labs, Recovery Rooms,
Neonatal Units and Renal Dialysis. |
2
10. Standards and quidelines reference
- CLSI EP5-A2; Evaluation of Precision Performance of Quantitative Measurement Methods; l Approved Guideline - Second Edition, Vol 24, No. 25, August 2004
- CLSI EP25-A; Evaluation of Stability of In Vitro Diagnostic Reagents; Approved Guideline, Vol --29, No. 20, September 2009
11. Stability
Real time stability studies have been performed for Eurotrol GAS-ISE Hct QC and Eurotrol GAS-ISE Hct LVM. The claimed stability is 24 months when the product is stored at 2-8°C, 10 days when the product is stored unopened at room temperature and 30 seconds after opening the ampules.
12. Value Assignment
Multiple replicates of test samples are measured at the beginning and end of the production run on various analyzers for metabolites and on blood gas analyzers for blood gas and pH values. Values are assigned on the Abbott i-STAT 300 System, using multiple cartridges of the latest available batches of the following cartridge types: CG4+, CG8+, EC8+, CHEM8+ and Crea. Values are determined by taking the mean of multiple determinations performed on randomly selected samples from each lot. Ranges are assigned using pre-determined intervals. Value assignment is performed for each lot of Eurotrol GAS-ISE Hct QC and Eurotrol GAS-ISE Hct LVM and for each new software (CLEW) update of the Abbott i-STAT 300 System.
The assigned values of each batch are available on a value sheet as per the example in Annex 1. on page 4 - 7.
13. Traceability
The different levels of Eurotrol GAS-ISE Hct QC and Eurotrol GAS-ISE Hct LVM are traceable to the reference materials as shown in the table below.
| Analyte | Reference Material |
|---|---|
| pH | NIST SRM: 186 I/II, 185, 187, 191 and 192 |
| pCO2 | NIST SRM: 1674b, 2625a, 2658a and 2659a |
| pO2 | NIST SRM: 1674b, 2625a, 2658a and 2659a |
| Na+ | NIST SRM 956b |
| K+ | NIST SRM 956b |
| Ca++ | NIST SRM 956b |
| Cl- | NIST SRM 956b |
| Glucose | NIST SRM 965c |
| Lactate | Biomed DuoCal Multi 10260 |
| Urea | Precipath U plus 159955 + Precinorm U plus 157249 |
| Creatinine | NIST SRM 967a |
| Hematocrit | |
| (Conductivity) | Hanna Instruments Conductivity Standard 1.413 mS/cm |
| Hanna Instruments Conductivity Standard 5.000 mS/cm | |
| Hanna Instruments Conductivity Standard 12.88 mS/cm |
Table 2. Traceability of the analytes of Eurotrol GAS-ISE Hct QC and Eurotrol GAS-ISE Hct LVM to reference materials.
14. Conclusion
Eurotrol GAS-ISE Hct QC and Eurotrol GAS-ISE Hot LVM is intended to be used for the same intended use as the predicate and performs similarly as the predicate device.
3
| LOT 17401215 | |||
|---|---|---|---|
| 17401215 | |||
| cartridge types, all lot numbers | |||
| Units | X (Mean) | R (Range) | |
| pH | 1 | 6.973 | 6.893 - 7.054 |
| pCO₂ | mmHg | 73.0 | 58.6 - 87.4 |
| kPa | 9.71 | 7.80 - 11.62 | |
| pO₂ | mmHg | 66 | 46 - 86 |
| kPa | 8.7 | 6.1 - 11.4 | |
| Na⁺ | mmol/L, mEq/L | 119 | 115 - 124 |
| K⁺ | mmol/L, mEq/L | 2.7 | 2.3 - 3.1 |
| iCa⁺⁺ | mmol/L | 1.40 | 1.29 - 1.51 |
| mEq/L | 2.8 | 2.6 - 3.0 | |
| mg/dL | 5.6 | 5.2 - 6.0 | |
| Cl⁻ | mmol/L, mEq/L | 83 | 77 - 88 |
| tCO₂ | mmol/L, mEq/L | 19 | 10 - 28 |
| Glucose/ | mg/dL | 303 | 257 - 349 |
| Glu | g/L | 3.03 | 2.57 - 3.49 |
| Lactate/ | mmol/L | 16.8 | 14.2 - 19.4 |
| mmol/L | 8.49 | 7.57 - 9.41 | |
| Lac | mg/dL | 76.5 | 68.2 - 84.8 |
| g/L | 0.765 | 0.682 - 0.848 | |
| BUN | mg/dL | 61 | 54 - 69 |
| Urea | mmol/L | 21.9 | 19.4 - 24.5 |
| mg/dL | 132 | 116 - 147 | |
| Creatinine/ | g/L | 1.32 | 1.16 - 1.47 |
| μmol/L | 324 | 248 - 400 |
Eurotool
Your Global Reference Point for Quality Components
/
Eurotre
Expecte
1
.
eurorid o Postbox 22 6/10 05 Een Replation 20 6/26 Edg. Ine Detredands, 1 -31 313 6515/70. dotes, constitution websited con
4
Image /page/4/Figure/0 description: This image is a document from Eurotrol, specifically for their GAS-ISE Hct QC product, intended for use with Abbott i-STAT devices. It presents the expected values for various parameters, including pH, pCO2, Na+, K+, Cl-, Glucose, BUN, Urea, and Hct, with corresponding mean values and acceptable ranges. The document also includes the lot number 17401215, a level indicator of 1, and a date of 2014-09.
2 2 1908101 20 100 12 244
erd B V. Postaal Z 2 6/10 BS Ede Repleitands 1 +31 318 69572 F -31 318 69572 F -31 318 69570 500 en stellerstere worden
5
| | Level 1
LEW: A26/C26/H26/J
2014-09
ಹಿ |
|----------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Eurotrol | 17401215
17401215 |
| | ി അമേരിക്കുകയും പ്രവരിച്ചു. പ്രശസ്ത പ്രവർത്തിച്ചു. പ്രശസ്ത പ്രവർത്തിച്ചു. പ്രശസ്ത പ്രാമത്തിലെ പ്രവാഹ്യമായി പ്രവർത്തിച്ചു. പ്രശസ്തകം
Expected values for Abbott i-STAT*
(Mean
989 989 9072