(15 days)
Liquichek™ Blood Gas Plus Co-Oximeter Control (IL Synthesis Series) is an assayed quality control intended for use in monitoring the precision of an individual laboratory's measurement of pH, pCO2, pO2, electrolytes, glucose, total hemoglobin, and hemoglobin fractions by blood gas, ion selective electrode (ISE), biosensor and IL Synthesis Co-Oximetry instrumentation.
Liquichek™ Blood Gas Plus CO-Oximeter Control (IL Synthesis Series) is a dye based, buffered bicarbonate and electrolyte solution in equilibrium with pre-determined levels of oxygen, carbon dioxide, nitrogen and glucose.
This document describes the safety and effectiveness of the "Liquichek™ Blood Gas Plus CO-Oximeter Control (IL Synthesis Series)" and seeks to establish its substantial equivalence to a predicate device.
1. Acceptance Criteria and Reported Device Performance
The acceptance criteria are implicitly derived from the comparison to the predicate device and the stability studies conducted. The goal is to demonstrate that the new device performs similarly to the predicate device and meets its stated stability claims.
| Acceptance Criteria Category | Specific Criteria | Reported Device Performance |
|---|---|---|
| Product Attributes | ||
| Levels | Three levels (consistent with predicate) | Three levels |
| Form | Liquid (consistent with predicate) | Liquid |
| Matrix | Buffered bicarbonate and electrolyte solution (consistent with predicate) | Buffered bicarbonate and electrolyte solution |
| Fill Volume | 1.7 mL (consistent with predicate) | 1.7 mL |
| Intended Use | Monitoring pH, pCO2, pO2, electrolytes, glucose, total hemoglobin, and hemoglobin fractions by blood gas, ion selective electrode (ISE), biosensor and IL Synthesis CO-Oximetry instrumentation (similar to predicate, but specifically for IL Synthesis). | An assayed quality control to monitor the precision of an individual laboratory's measurement of pH, pCO2, pO2, electrolytes, glucose, total hemoglobin, and hemoglobin fractions by blood gas, ion selective electrode (ISE), biosensor and IL Synthesis CO-Oximetry instrumentation. |
| Open Vial Stability | pH and blood gas measurements: Sample immediately after opening. CO-Oximeter, electrolyte, and glucose measurements: Sample within 10 minutes of opening to avoid evaporation. Discard remaining material. (Consistent with predicate's general guidance for these specific analytes, with lactate excluded from new device claims). | When the control is used for pH and blood gas measurements, the material should be sampled immediately after opening. When used only for Co-Oximeter, electrolyte, and glucose measurements, the material should be sampled within 10 minutes of opening to avoid evaporation. Once the control is sampled, discard remaining material. |
| Unopened Vial Stability | 3 years when stored at 2 - 8°C (consistent with predicate). 6 months when stored unopened at room temperature (20 - 25°C), not used past expiration date, and avoid temperatures 30°C and direct sunlight (Different from predicate's 12 months at room temperature). Real-time studies to be ongoing to support shelf life. | 3 years when stored unopened at 2 - 8°C. The control may be stored unopened at room temperature (20 to 25°C) for 6 months, but should not be used past the expiration date (note the date room temperature storage begins). Avoid exposures to temperatures 2°C or above 30°C. Do not store in direct sunlight. Real-time studies will be ongoing to support the shelf life of this product. All supporting data is retained on file at Bio-Rad Laboratories. |
| Instrument Compatibility | Made to run on the IL Synthesis CO-Oximetry instrumentation (specific to the new device, predicate was for IL CO-Oximetry instrumentation). | Made to run on the IL Synthesis CO-Oximetry instrumentation. |
| Claimed Analytes | pH, pCO2, pO2, Calcium-ionized, Chloride, Potassium, Sodium, Glucose, Total Hemoglobin, Oxyhemoglobin, Carboxyhemoglobin, Methemoglobin, Reduced Hemoglobin, and Oxygen Saturation (similar to predicate, but notably excluding Lactate and Volume Percent Oxygen/Oxygen Capacity, and including Oxygen Saturation). | pH, pCO2, pO2, Calcium-ionized, Chloride, Potassium, Sodium, Glucose, Total Hemoglobin, Oxyhemoglobin, Carboxyhemoglobin, Methemoglobin, Reduced Hemoglobin, and Oxygen Saturation. |
2. Sample Size and Data Provenance (for test set)
The document states that "Stability studies have been performed to determine the open vial stability and shelf life for the Liquichek™ Blood Gas Plus CO-Oximeter Control (IL Synthesis Series)." It also mentions that "All supporting data is retained on file at Bio-Rad Laboratories."
- Sample Size: The specific sample sizes (number of vials, replicates, lots, or dates during stability studies) used for the stability testing (which serve as the "test set" for the performance claims) are not explicitly stated in the provided text.
- Data Provenance: The data provenance is from Bio-Rad Laboratories, the submitter of the device. The study is a prospective stability study conducted on the new device, designed to support its stated claims. The country of origin for the data is implicitly the United States, as Bio-Rad Laboratories is based in Irvine, California, and the submission is to the FDA.
3. Number of Experts and Qualifications (for ground truth of test set)
This device is an assayed quality control material for laboratory instruments. The "ground truth" for its performance is typically established through analytical methods and instrument readings, not expert human interpretation. Therefore, the concept of "experts" in the traditional sense (e.g., radiologists) for establishing ground truth is not applicable here.
- Number of Experts: Not applicable.
- Qualifications of Experts: Not applicable.
4. Adjudication Method (for test set)
Since the ground truth is established through analytical measurements and a comparison to predefined stability limits and performance metrics, an adjudication method for human interpretation is not applicable. The performance is assessed against established measurement procedures and statistical analysis of the stability data.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- Was an MRMC study done? No.
- Effect Size: Not applicable, as this is an in-vitro diagnostic control material, not a diagnostic imaging aid for human readers.
6. Standalone Performance Study (Algorithm Only)
- Was a standalone study done? Yes, to the extent that "standalone" refers to the device itself being tested independently to determine its inherent performance characteristics (stability, analyte values on compatible instruments). The stability studies are effectively a standalone performance assessment of the control material's behavior over time and under different conditions. The "Summary of Performance Data" directly reports on the outcomes of these studies.
7. Type of Ground Truth Used
The ground truth used for this device is based on:
- Analytical Measurements/Instrument Readings: The stability studies involve repeatedly measuring the analytes (pH, pCO2, pO2, electrolytes, glucose, total hemoglobin, and hemoglobin fractions) in the control material using specified instrumentation (IL Synthesis CO-Oximetry instrumentation) over time and under various storage conditions.
- Defined Chemical/Physical Properties: The control material is designed with predetermined levels of oxygen, carbon dioxide, nitrogen, and glucose, and its matrix is a buffered bicarbonate and electrolyte solution. The expected values for the analytes are what the device is "controlling" against.
- Comparison to Predicate Device: Substantial equivalence claims heavily rely on demonstrating that the new device's performance is comparable to the legally marketed predicate device, implying that the predicate's established performance serves as a reference point for acceptable ground truth.
8. Sample Size for the Training Set
This device is a quality control material, not an AI/ML algorithm that requires a "training set" in the conventional sense. Therefore, the concept of a training set sample size is not applicable. The manufacturing process for the control material involves precise formulation and quality checks, but not algorithmic training.
9. How the Ground Truth for the Training Set was Established
As there is no "training set" for this type of device, this question is not applicable.
§ 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.