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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 Hct 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 Hct LVM is for in vitro diagnostic use only.

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.

AI/ML Overview

The provided 510(k) summary (K131595) for Eurotrol GAS-ISE Hct QC and Eurotrol GAS-ISE Hct LVM describes quality control materials for blood gas, electrolyte, and metabolite analysis. This submission focuses on the performance claims and stability of these control materials for use with the Abbott i-STAT® POCT analyzer.

Here's an analysis of the acceptance criteria and supporting study information, based on the provided document:

Acceptance Criteria and Reported Device Performance

The device itself is a quality control material, not a diagnostic device that produces patient-specific results. Therefore, the "device performance" in this context refers to the assigned values and ranges for the various analytes within the control material, and its stability.

The acceptance criteria are implicitly defined by the assigned value ranges for each analyte, which are developed to verify the precision and accuracy of the Abbott i-STAT® POCT analyzer. The reported device performance is specifically the mean and range provided for each analyte in the lot-specific value sheets.

For example, section {3} and {5} provide tables for Eurotrol GAS-ISE Hct QC (Lot 17401215, Level 1) with specific values and ranges for various analytes.

Analyte	Unit	Mean (X)	Range (R)
pH	1	6.973	6.893 - 7.054
pCO₂	mmHg	73.0	58.6 - 87.4
pO₂	mmHg	66	46 - 86
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
Cl⁻	mmol/L, mEq/L	83	77 - 88
tCO₂	mmol/L, mEq/L	19	10 - 28
Glucose	mg/dL	303	257 - 349
Lactate	mmol/L	8.49	7.57 - 9.41
Urea	mmol/L	21.9	19.4 - 24.5
Creatinine	μmol/L	324	248 - 400

(Note: The tables in the input have some inconsistencies and overlapping information. The table above consolidates and clarifies based on the available data for 'Level 1' of the 'Eurotrol GAS-ISE Hct QC' found in {3} and {5}.)

Study Design and Evidence Pertaining to Acceptance Criteria

The studies described are primarily focused on value assignment, stability, and traceability of the control materials, rather than a clinical study evaluating diagnostic accuracy against a ground truth.

1. Sample size used for the test set and the data provenance:

Test Set Description: The "test set" in this context refers to the samples of the control materials from each lot that are analyzed to determine their assigned values and ranges.
Sample Size: "Multiple replicates of test samples" are measured. The exact number of replicates is not specified, but it's stated that values are determined by "the mean of multiple determinations performed on randomly selected samples from each lot." This implies multiple ampules from each production lot are tested multiple times.
Data Provenance: The studies are conducted by Eurotrol B.V., which is based in The Netherlands. The testing involves the Abbott i-STAT 300 System and various Abbott i-STAT cartridge types (CG4+, CG8+, EC8+, CHEM8+, Crea). The data is generated prospectively during the manufacturing and quality control process for each lot.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

No external experts are explicitly mentioned for establishing a "ground truth" in the typical sense of diagnostic imaging or clinical assessment.
The "ground truth" for these control materials is established by traceable reference materials and the performance of the specified analytical instruments. Section {13} meticulously lists the NIST Standard Reference Materials (SRMs) and other reference materials used for each analyte (e.g., NIST SRM 186 I/II, 185, 187, 191 and 192 for pH; NIST SRM 956b for Na+, K+, Ca++, Cl-).
The "experts" involved are likely the highly trained laboratory personnel at Eurotrol B.V. who perform the value assignment using validated methods and traceable standards. Their specific qualifications are not detailed in the summary.

3. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

No explicit adjudication method is described. The value assignment process involves taking the "mean of multiple determinations." This approach intrinsically averages out minor variations, but there isn't a stated independent review or adjudication process by multiple individuals or systems beyond the initial measurements.

4. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

No MRMC study was performed. This device is a quality control material for an in-vitro diagnostic device (Abbott i-STAT POCT analyzer), not an AI-based diagnostic tool for human interpretation. Therefore, the concept of "human readers improving with AI" is not applicable here.

5. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:

This is not an algorithm-only device. It is a physical quality control material. However, the value assignment process (section {12}) for the control material is a "standalone" process in the sense that the control material is characterized independently of its ultimate use by individual operators, and these assigned values define its expected performance. The performance of the Abbott i-STAT analyzer itself with this control material is what's being verified.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

The "ground truth" for the content of these control materials is established through traceability to internationally recognized reference materials (NIST SRMs) and other certified reference materials (Biomed DuoCal, Precipath U plus, Precinorm U plus, Hanna Instruments Conductivity Standards). This provides a highly accurate and standardized basis for the assigned values.

7. The sample size for the training set:

No specific "training set" in the context of machine learning is described. The concept of training data doesn't apply directly to this type of device. The control material itself is manufactured, and then its properties (assigned values and ranges) are determined.
However, the validation and establishment of the value assignment methodology would have relied on extensive testing and historical data for the Abbott i-STAT system, which could be considered analogous to a "training" phase for the manufacturer's internal processes. The summary mentions using "multiple cartridges of the latest available batches of the following cartridge types: CG4+, CG8+, EC8+, CHEM8+ and Crea" for value assignment, suggesting a broad basis for establishing the expected performance on the target analyzer.

8. How the ground truth for the training set was established:

As there is no "training set" in the machine learning sense, this question is not directly applicable. If we consider the "ground truth" for setting the manufacturing specifications and the value assignment methodology, it would again stem from traceability to reference materials, established analytical chemistry principles, and comprehensive statistical analysis of the performance on the Abbott i-STAT system over time.

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