(15 days)
Liquichek™ Blood Gas Plus Co-Oximeter Control (Radiometer 700 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, lactate (lactic acid), total hemoglobin, and hemoglobin fractions by blood gas, ion selective electrode (ISE), biosensor and Radiometer 700 Series CO-Oximetry instrumentation.
Liquichek™ Blood Gas Plus CO-Oximeter Control (Radiometer 700 Series) is a dye based, buffered bicarbonate and electrolyte solution in equilibrium with pre-determined levels of oxygen, carbon dioxide, nitrogen, glucose and lactate (lactic acid).
Here's an analysis of the provided text regarding the Bio-Rad Laboratories Premarket Notification Section 510(k) for Liquichek Blood Gas Plus CO-Oximeter 700 Series.
It's important to note that this document is a 510(k) premarket notification for a quality control material, not a medical device in the sense of an algorithm or diagnostic tool that directly analyzes patient data. Therefore, the questions related to AI, human readers, ground truth establishment for AI, and similar concepts are not directly applicable. I will address the relevant points based on the nature of the device.
Acceptance Criteria and Device Performance for Liquichek Blood Gas Plus CO-Oximeter Control (Radiometer 700 Series)
1. Table of Acceptance Criteria and Reported Device Performance
The core "performance" of a quality control material is its stability and its ability to monitor the precision of an instrument. The acceptance criteria are typically related to maintaining target values and stability over time under specified storage conditions. The document focuses on demonstrating substantial equivalence to a predicate device, primarily through stability studies.
| Acceptance Criterion (Implied) | Reported Device Performance |
|---|---|
| Open Vial Stability (pH and blood gas) | Material should be sampled immediately after opening. |
| Open Vial Stability (CO-Oximeter, electrolytes, glucose) | Material should be sampled within 10 minutes of opening to avoid evaporation. |
| Unopened Vial Shelf Life (2-8°C storage) | Stable for 3 years. |
| Unopened Vial Room Temperature Stability (20-25°C storage) | Stable for 12 months. (Must note the date room temperature storage begins and should not be used past the overall expiration date). Avoid temperatures below 2°C or above 30°C. Do not store in direct sunlight. Real-time studies are ongoing to support this, indicating that this is the claimed intended performance. |
| Substantial Equivalence to Predicate Device (K002536) | Claimed via similarities in levels, form, matrix, shelf life, and open vial claim (for pH/blood gas). Differences (fill volume, room temperature storage stability, specific instrument compatibility, and one analyte exclusion) are deemed not to raise new questions of safety or effectiveness. |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: The document does not specify a numerical "sample size" in terms of how many individual tests or vials were used for the stability studies. For a quality control product, this would typically involve multiple lots or batches tested over time at various intervals. The document states "Stability studies have been performed..." without quantitative details.
- Data Provenance: The studies were performed by Bio-Rad Laboratories. The country of origin is implicitly the USA (Bio-Rad Laboratories is based in Irvine, California). The studies described are prospective in nature, as they are "stability studies" performed to determine shelf life and open vial stability for the new device prior to its market release.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. For a quality control material, "ground truth" isn't established by human experts in a diagnostic sense. Instead, the "ground truth" or reference values for the control material's analytes (e.g., pH, pCO2, glucose levels) are established through manufacturing processes, assaying against known standards, and rigorous internal quality control procedures to ensure homogeneity and accurate assigned values for each level of the control. The document refers to the product as an "assayed quality control," meaning it has assigned values.
4. Adjudication Method for the Test Set
Not applicable. There's no "adjudication" in the context of a quality control material's stability testing. The assessment is based on objective analytical measurements and pre-defined acceptance limits for stability.
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 a quality control material, not an AI-assisted diagnostic tool.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) Was Done
Not applicable. This is a physical, chemical quality control product, not an algorithm.
7. The Type of Ground Truth Used
The "ground truth" for this type of product refers to the assigned values of the analytes (pH, pCO2, pO2, electrolytes, glucose, lactate, total hemoglobin, and hemoglobin fractions) within each level of the control material. These values are established by the manufacturer (Bio-Rad) through:
- Rigorous analytical testing using reference methods and calibrated instruments.
- Ensuring batch-to-batch consistency.
- Determining the target range for each analyte for each level of the control.
The purpose of the control is then for laboratories to monitor their own instrument's precision against these known assigned values.
8. The Sample Size for the Training Set
Not applicable. This is not a machine learning or AI device that requires a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable. As noted above, this device does not utilize a "training set." The "ground truth" for the control material itself (i.e., its assigned values) is established through the described manufacturing and analytical processes.
§ 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.