(26 days)
Liquichek Whole Blood Volatiles Control is intended for use as a quality control material to monitor the precision of laboratory testing procedures for the analytes listed in the package insert.
This product is prepared from human blood with chemicals and preservatives added. The control is provided in liquid form for convenience.
Here's a breakdown of the acceptance criteria and study information for the Liquichek Whole Blood Volatiles Control, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
The document primarily focuses on the intended use and stability of the device, rather than specific performance metrics against a numerical acceptance criterion for e.g., accuracy or sensitivity. The acceptance criteria here relate to demonstrating that the control material maintains its stability over time and is suitable for its intended purpose (monitoring precision).
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Intended Use | "Liquichek Whole Blood Volatiles Control is intended for use as a quality control material to monitor the precision of laboratory testing procedures for the analytes listed in the package insert." The new device's intended use is identical to the predicate device. |
| Open Vial Stability | "5 days at 2 to 8°C." |
| Shelf Life | "2 years at 2 to 8°C." |
2. Sample Size Used for the Test Set and Data Provenance:
The document states that "Stability studies have been performed," but it does not specify the sample size used for these studies.
The data provenance is Bio-Rad Laboratories, the device manufacturer. The type of study described (stability studies) is inherently prospective as it involves tracking the product's performance over time. The country of origin for the data is not explicitly stated, but as Bio-Rad Laboratories is based in Irvine, California, it is likely United States.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
This information is not applicable or provided in the current document. The device is a quality control material, meaning its "ground truth" relates to its inherent stability and consistency, rather than a diagnostic accuracy that would require expert interpretation. The stability studies likely involved laboratory measurements against calibrated standards, not expert adjudication of results.
4. Adjudication Method for the Test Set:
This information is not applicable or provided. See point 3 above.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
No MRMC comparative effectiveness study was mentioned or performed. This type of study is typically relevant for diagnostic devices that involve human interpretation of results, which is not the case for a quality control material.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:
This information is not applicable or provided. The device is a physical control material, not an algorithm. Its performance is evaluated through its physical and chemical stability, and its ability to consistently provide expected values when tested.
7. Type of Ground Truth Used:
The ground truth for the stability studies would be the measured concentrations of the analytes (Acetone, Ethanol, Isopropanol, Lead, Methanol) within the control material, compared to established reference values or against its initial measured concentrations. This would involve analytical testing and measurement against validated standards or methods, rather than expert consensus, pathology, or outcomes data.
8. Sample Size for the Training Set:
This information is not applicable or provided. The device is a physical control material and does not involve a "training set" in the machine learning sense. The manufacturing process is controlled to ensure consistency across batches.
9. How the Ground Truth for the Training Set Was Established:
This information is not applicable or provided. See point 8 above.
§ 862.3280 Clinical toxicology control material.
(a)
Identification. A clinical toxicology control material is a device intended to provide an estimation of the precision of a device test system and to detect and monitor systematic deviations from accuracy resulting from reagent or instrument defects. This generic type of device includes various single, and multi-analyte control materials.(b)
Classification. Class I (general 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.