(22 days)
The products encompassed by this request are intended for in vitro diagnostic use and are intended for use in calibrating the electrodes and cleaning / flushing the sample flow path of the equivalent ABL™ pH/Blood Gas Systems. Radiometer Medical/Copenhagen is the Original Equipment Manufacturer of the analyzers and of the predicate Reagents. The ABL™ pH/Blood Gas Analyzers perform a broad array of blood gas and co-oximetery tests. ALKO manufactures the calibration reagents for the analyzer's analyte pH, (concentration of hydrogen ions) which is measured by glass membrane electrodes. ALKO also manufactures the Cleaning, Rinse, Hypochlorite and Salt Bridge Solution. These Reagents are intended to be used with equivalent ABL™ pH/Blood Gas Analyzers. As such, ALKO products are intended to serve as direct replacements to like named products manufactured by Radiometer Medical/Copenhagen.
The Calibration Solution, pH 7.4/ 3 and Calibration Solution, pH 6.8/ 4 are intended to provide calibration points for the pH electrode on the analyzer. The Salt Bridge Solution /2 provides a liquid junction through the reference electrode during calibration and measurement. The Cleaning Solution /1, Rinse Solution /5 and Hypochlorite Solution are intended for maintenance of the analyzers electrodes and sample flow path. The products encompassed are to be handled using normal laboratory precautions.
The products encompassed by this 510(k) submission are Class II (75JIX) In Vitro Diagnostic Solutions manufactured by ALKO Diagnostic Corporation, 333 Fiske Street, Holliston, MA 01746. The Reagents are intended for use on equivalent ABL™ pH/ Blood Gas Analyzers. Radiometer Medical/Copenhagen is the original equipment manufacturer (OEM) of the analyzers and of predicate reagents which are necessary for the continued operation and use of the analyzers.
ALKO manufactures the calibration reagents for the analyzer's analyte pH (concentration of hydrogen ions) which is measured by the glass membrane electrode. ALKO also manufactures the Cleaning, Rinse, Hypochlorite and Salt Bridge Solution. The ALKO Reagents are intended to serve as direct replacements to like named products manufactured by Radiometer Medical /Copenhagen. The Calibration Solutions, pH 7.4/3 and Calibration Solution, pH 6.8/4 are buffered solutions for calibration of the pH electrode. The Salt Bridge Solution /2 provides a liquid junction through the reference electrode and the sample during calibration and measurement. The Cleaning Solution /S and Hypochlorite olution are all used to clean and rinse the analyzers electrodes, and sample flow path.
The provided text describes the acceptance criteria and study proving equivalence for ALKO Reagents as direct replacements for Radiometer Medical/Copenhagen reagents on ABL™ pH/Blood Gas Analyzers.
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are implied to be performance equivalence to the predicate Radiometer Medical/Copenhagen reagents. This is demonstrated through two types of studies: a method comparison (accuracy) and a precision study.
Precision Data (Measured one run per day for twenty days)
| Analyte | Metric | N | Mean | STD | CV% | Min | Max |
|---|---|---|---|---|---|---|---|
| Level 1 | |||||||
| pH | Total | 60 | 7.155 | 0.0025 | 0.0344 | 7.149 | 7.159 |
| Run to Run | 20 | 7.155 | 0.0023 | 0.0325 | 7.149 | 7.157 | |
| pCO2 | Total | 60 | 73.5 | 0.8096 | 1.1022 | 72.2 | 75.8 |
| Run to Run | 20 | 73.5 | 0.7140 | 0.9720 | 72.5 | 75.6 | |
| pO2 | Total | 60 | 76.4 | 1.2870 | 1.6848 | 73.9 | 79.2 |
| Run to Run | 20 | 76.4 | 0.9898 | 1.2951 | 74.8 | 78.7 | |
| Level 2 | |||||||
| pH | Total | 60 | 7.370 | 0.0022 | 0.0301 | 7.365 | 7.381 |
| Run to Run | 20 | 7.370 | 0.0015 | 0.0209 | 7.367 | 7.374 | |
| pCO2 | Total | 60 | 44.2 | 0.5873 | 1.3296 | 43.4 | 47.5 |
| Run to Run | 20 | 44.2 | 0.3177 | 0.7193 | 43.8 | 45.1 | |
| pO2 | Total | 60 | 102.2 | 1.8308 | 1.7906 | 98.7 | 109.9 |
| Run to Run | 20 | 102.2 | 1.5290 | 1.4955 | 99.5 | 105.3 | |
| Level 3 | |||||||
| pH | Total | 60 | 7.576 | 0.0026 | 0.0345 | 7.571 | 7.586 |
| Run to Run | 20 | 7.576 | 0.0020 | 0.0267 | 7.572 | 7.579 | |
| pCO2 | Total | 60 | 20.3 | 0.4511 | 2.2171 | 17.4 | 20.8 |
| Run to Run | 20 | 20.3 | 0.3096 | 1.5214 | 19.2 | 20.8 | |
| pO2 | Total | 60 | 157.4 | 3.6420 | 2.3146 | 149.0 | 165.3 |
| Run to Run | 20 | 157.4 | 3.1385 | 1.9946 | 151.0 | 163.3 |
Accuracy (Correlation with Radiometer ABL™ Reagents)
| Analyte | N | Slope | Intercept | R Squared * | Range |
|---|---|---|---|---|---|
| pH | 51 | 1.0068 | -0.04888 | 0.9998 | 6.816 - 7.987 |
| pCO2 | 51 | 1.0106 | -0.14954 | 0.9995 | 5.1- 152.7 |
| pO2 | 51 | 0.9961 | 0.46989 | 0.9995 | 12.6 - 285.0 |
R Squared = Correlation Coefficient Squared. The acceptance criteria for these correlation values are not explicitly stated but are implicitly for high correlation (close to 1 for R-squared, slope close to 1, intercept close to 0) to demonstrate equivalence.
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size:
- Precision study: 20 days of measurements for each of 3 control levels (resulting in N=60 for "Total" and N=20 for "Run to Run" for each analyte at each level).
- Accuracy (Method Comparison) study: 51 blood samples.
- Data Provenance: Not explicitly stated but inferred to be from laboratory testing involving ALKO and Radiometer reagents on ABL™ 500 analyzers. There is no information about country of origin beyond "Holliston, MA" for ALKO and "Radiometer Medical/Copenhagen," or whether the data is retrospective or prospective. It is implied to be prospective testing conducted for the 510(k) submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. This device involves chemical reagents and instrument performance, not interpretation by human experts. The "ground truth" for the accuracy study is derived from measurements performed using the predicate Radiometer Medical/Copenhagen reagents.
4. Adjudication Method for the Test Set
Not applicable, as this is a performance study for chemical reagents and not an assessment requiring expert adjudication of results.
5. 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
Not applicable. This is not an AI-assisted diagnostic device or an imaging product requiring human reader interpretation.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is essentially a "standalone" performance study for the reagents, as it evaluates their intrinsic performance when used on the specified analyzers without human interpretive element. The results are quantitative measurements.
7. The type of ground truth used
- Precision Study: The ground truth is the inherent concentration or value of the control materials. The study aims to demonstrate reproducibility around this ground truth.
- Accuracy (Method Comparison) Study: The "ground truth" is established by the measurements obtained using the predicate Radiometer Medical/Copenhagen reagents on an equivalent ABL™ 500 analyzer. The ALKO reagents are compared against these established values to demonstrate "equivalence."
8. The sample size for the training set
Not applicable. This is not a machine learning model or an AI device that requires a training set in the conventional sense. The development of the ALKO reagents would involve internal R&D and formulation work, but this document describes the validation of the final product for regulatory submission.
9. How the ground truth for the training set was established
Not applicable, as there is no training set in the context of this device.
§ 862.1150 Calibrator.
(a)
Identification. A calibrator is a device intended for medical purposes for use in a test system to establish points of reference that are used in the determination of values in the measurement of substances in human specimens. (See also § 862.2 in this part.)(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.