(23 days)
Assayed quality control serum to monitor the precision of laboratory testing procedures for the analytes listed in the package insert
Liquichek™ Lipids Control is prepared from human serum with added constituents of human and animal origin, pure chemicals preservatives and stabilizers. The control is provided in liquid form for convenience.
The provided document is a 510(k) summary for a medical device (Liquichek™ Lipids Control) and lacks the detailed study information typically found in a clinical trial report or a comprehensive validation study. Therefore, I cannot fully answer all the questions as the specific details requested, such as sample sizes for test and training sets, number of experts, adjudication methods, or MRMC study results, are not present.
However, I can extract the available information regarding acceptance criteria and performance as related to the device's stability.
Here's a breakdown of the available information:
Acceptance Criteria and Reported Device Performance
The acceptance criteria are implicitly defined by the stability claims made for the Liquichek™ Lipids Control. The device is considered to meet these criteria if it maintains its intended function as an assayed quality control serum within the specified storage conditions and timeframes.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Thawed and unopened vial stability: Maintain stability for 14 days at 2-8°C. | "Once the control material is thawed and the vial is unopened all analytes will be stable for 14 days at 2-8°C." (This statement acts as both the claim and the reported performance based on stability studies.) |
| Open vial stability: Maintain stability for 14 days when stored tightly capped at 2-8℃. | "Once the control material is thawed and opened, all analytes will be stable for 14 days when stored tightly capped at 2-8℃." (This statement acts as both the claim and the reported performance based on stability studies.) |
| Shelf Life (unopened): Maintain stability for 36 months when stored at -10 to -20 °C. | "36 months when stored at -10 to -20 °C." (This statement acts as both the claim and the reported performance based on stability studies.) The document also states, "Real time studies will be ongoing to support the shelf life of this product," indicating that preliminary data supported the claim, and further studies were in progress to fully validate it over the entire 36 months. |
Information Not Available in the Provided Document:
- Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): The document mentions "Stability studies have been performed," but does not provide details on sample sizes, specific experimental design, or data provenance.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience): This is not applicable to a quality control material stability study. The "ground truth" would be the measured analyte concentrations over time, not expert consensus.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable in this context.
- 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 device is a quality control material, not an AI-powered diagnostic device interpreted by human readers.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an algorithm-based device.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): For this type of device, the "ground truth" for stability would be the analytical measurements of the analytes themselves, traceable to reference methods or materials, to ensure they remain within predefined acceptable ranges over time. However, the specific methods are not detailed here.
- The sample size for the training set: Not applicable. This is not a machine learning or AI device that requires a training set.
- How the ground truth for the training set was established: 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.