(15 days)
The products encompassed by this request are intended for in vitro diagnostic use and are intended for use in calibrating the electrodes and flushing the sample flow path of the equivalent Chiron (Ciba-Corning) pH/Blood Gas Analyzer. Chiron Diagnostics is the Original Equipment Manufacturer of the analyzers and of the predicate Reagents. The Chiron (Ciba-Corning) pH/Blood Gas Analyzer performs a broad array of blood gas 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 Wash Solution. These Reagents are intended to be used with equivalent Chiron (Ciba-Corning) pH/Blood Gas Analyzers. As such. ALKO products are intended to serve as direct replacements to like named products manufactured by Chiron Diagnostics.
The Buffer Solution 7.3, and Buffer Solution 6.8, are intended to provide calibration points for the pH electrode on the analyzer. The Wash Solution is intended for rinse of the analyzers 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 I he products chooligable of assis Corporation, 333 Fiske Street, Holliston, MA 01746. The Reagents are intended for use on equivalent Chiron (Ciba-Corning) pH/ Blood Gas Analyzers. Chiron Diagnostics (formally Ciba-Corning) 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 buffer reagents for the analyzer's analyte pH (concentration of hydrogen ions) which is measured by the glass membrane electrode. ALKO also pri (6.nouther the Wash Solution. The ALKO Reagents are intended to serve as direct replacements to like named oroducts manufactured by Chiron Diagnostics. The Buffer Pack which consists of one bottle each of 6.8 and 7.3 Buffer, are Buffered Solutions for calibration of the pH electrode. The Wash Solution is used to rinse the analyzers sample flow path.
- ALKO product A473-496 (6.8 / 7.3 Buffer Pack) is equivalent to Chiron Diagnostics product 473496 . (6.8 / 7.3 Buffer Pack).
- ALKO Product A473-497 (Wash Solution), is equivalent to Chiron Diagnostics product 473497 . (Wash Solution).
ALKO uses a similar composition and packaging design as that used by Chiron Diagnostics in its products.
Here's a breakdown of the acceptance criteria and study information for the ALKO Reagents on CHIRON pH/ Blood Gas Analyzer, based on the provided text:
Acceptance Criteria and Device Performance Study for ALKO Reagents
The ALKO Reagents (6.8 / 7.3 Buffer Pack and Wash Solution) are intended as direct replacements for Chiron Diagnostics' equivalent products used on Chiron (Ciba-Corning) pH/Blood Gas Analyzers. The primary goal of the study was to demonstrate performance equivalence.
1. Table of Acceptance Criteria and Reported Device Performance
The submission focuses on demonstrating equivalence rather than setting explicit acceptance criteria as pass/fail thresholds. Instead, it presents performance data for ALKO reagents and compares it to the expected performance characteristics of a blood gas analyzer to show that the ALKO reagents perform comparably to the predicate Chiron reagents. The "acceptance criteria" thus are implicit in the demonstration of adequate precision and strong correlation with the predicate reagents.
Precision Data (Measured with ALKO Reagents)
| Parameter | Level | N | Mean | STD | CV% |
|---|---|---|---|---|---|
| pH | 1 | 40 | 7.166 | 0.0025 | 0.0351 |
| pH | 2 | 40 | 7.431 | 0.0019 | 0.0262 |
| pH | 3 | 40 | 7.653 | 0.0030 | 0.0394 |
| pCO2 | 1 | 40 | 79.3 | 1.2343 | 1.5574 |
| pCO2 | 2 | 40 | 43.7 | 0.4989 | 1.1409 |
| pCO2 | 3 | 40 | 18.9 | 0.1856 | 0.9811 |
| pO2 | 1 | 40 | 57.6 | 1.5465 | 2.6843 |
| pO2 | 2 | 40 | 96.2 | 1.1632 | 1.2089 |
| pO2 | 3 | 40 | 149.3 | 2.8649 | 1.9183 |
Correlation Data (ALKO vs. Chiron Reagents)
| Parameter | N | R² (Correlation Coefficient Squared) | Intercept | Slope | Range |
|---|---|---|---|---|---|
| pH | 120 | 0.9949 | 0.0382 | 0.9939 | 6.946 - 7.962 |
| pCO2 | 120 | 0.9968 | 0.1342 | 0.9931 | 9.3 - 101.8 |
| pO2 | 120 | 0.9977 | 0.0608 | 0.9983 | 2.4 - 293.1 |
The high R² values (close to 1) and slopes close to 1 with small intercepts demonstrate excellent correlation and equivalence between the ALKO reagents and the predicate Chiron reagents across the tested ranges for pH, pCO2, and pO2. The precision data indicates that the ALKO reagents allow the analyzer to maintain acceptable levels of precision for each analyte.
2. Sample Size Used for the Test Set and Data Provenance
- Precision Study:
- Sample Size: For each of three control levels (Level 1, 2, 3), 40 measurements were taken for pH, pCO2, and pO2. These were collected from measuring "three levels of control materials, measured in duplicate per run, four runs per day for five days". This means (2 duplicates/run * 4 runs/day * 5 days = 40 measurements per level).
- Data Provenance: The study was conducted on a Chiron 248 pH/blood gas analyzer, calibrated with ALKO reagents. The control materials are not specified, but the study implies a laboratory setting. No country of origin is explicitly stated, nor is it explicitly stated if it's retrospective or prospective, but the description of the experimental setup suggests a prospective study.
- Correlation Study:
- Sample Size: 120 human blood samples were used for pH, pCO2, and pO2 measurements.
- Data Provenance: The samples were "human blood samples" measured on "two Chiron 248 analyzers; one calibrated with all ALKO reagents as compared with all Chiron reagents." The data provenance is human blood samples, and it's a prospective method comparison study.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
Not applicable. This type of submission (IVD reagents for a blood gas analyzer) typically relies on quantitative measurements against known standards (control materials) or comparison to a predicate device's measurements, rather than expert consensus on interpretive tasks. The ground truth for the precision study is the established values of the control materials, and for the correlation study, it's the results generated by the predicate Chiron reagents.
4. Adjudication Method for the Test Set
Not applicable. As described in point 3, the studies involve quantitative measurements and direct comparison, not subjective evaluations requiring adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done. This type of study is relevant for interpretive tasks where human readers assess cases, often with and without AI assistance (e.g., radiology image interpretation). This submission is for in vitro diagnostic reagents where performance is assessed quantitatively and directly, not through human interpretation.
6. If a Standalone Study Was Done
Yes, a standalone study (algorithm-only, or in this case, reagent-only performance) was done for the precision data. The precision data demonstrates the performance of the analyzer when calibrated solely with ALKO reagents (i.e., ALKO reagents "standalone" from the predicate reagents). It shows the inherent variability of the test system using the new reagents.
The correlation study is a direct comparison study, not a standalone study, as it directly compares ALKO performance to Chiron performance.
7. The Type of Ground Truth Used
- Precision Study: The ground truth for the precision study is the expected values of the control materials used. These materials have known, established concentrations for pH, pCO2, and pO2. The study aims to show that when using ALKO reagents, the analyzer can consistently measure these known values with acceptable variability.
- Correlation Study: The ground truth for the correlation study is the measurements obtained from the same human blood samples analyzed on a Chiron 248 analyzer calibrated with the predicate Chiron Diagnostics reagents. The goal is to show that ALKO reagents yield results that are highly correlated and equivalent to those obtained with the already approved predicate reagents.
8. The Sample Size for the Training Set
Not applicable. The ALKO products are reagents for an in vitro diagnostic device, not an AI/ML algorithm. Therefore, there is no "training set" in the context of machine learning. The studies described are validation and comparison studies for the chemical reagents.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for this type of medical device submission.
§ 862.1120 Blood gases (P
CO2 , PO2 ) and blood pH test system.(a)
Identification. A blood gases (PCO2 , PO2 ) and blood pH test system is a device intended to measure certain gases in blood, serum, plasma or pH of blood, serum, and plasma. Measurements of blood gases (PCO2 , PO2 ) and blood pH are used in the diagnosis and treatment of life-threatening acid-base disturbances.(b)
Classification. Class II.