(40 days)
For use as a quality control serum to monitor the precision of an individual laboratory's automated and manual-testing procedures.
Quest Diagnostics Serum Chemistry Control is prepared from human serum to which purified biochemical materials (tissue extracts of human and animal origin), chemicals. preservatives, and stabilizers have been added.
Here's an analysis of the provided text regarding the Quest Diagnostics Serum Chemistry Control, focusing on acceptance criteria and study details:
This device is a Quality Control (QC) material, not a diagnostic device that produces patient results or relies on AI. Therefore, many of the requested fields (e.g., number of experts, adjudication methods, MRMC studies, standalone performance, training set) are not applicable to this type of product.
1. Table of Acceptance Criteria and Reported Device Performance
| Criteria (Claimed Performance) | Reported Device Performance |
|---|---|
| Intended Use | To monitor the precision of an individual laboratory's automated and manual-testing procedures. |
| Open Vial Stability (Unopened Frozen) | 10 days when stored tightly capped at 2-8°C. |
| Shelf Life (Unopened Frozen) | Two years when stored at -10 to -20 °C. |
| Form | Liquid |
| Matrix | Human serum based |
| Other Ingredients | Stabilizers and preservatives |
| Analytes | ALT, Albumin, Alkaline Phosphatase, Amylase, AST, Direct Bilirubin, Total Bilirubin, Blood Urea Nitrogen, Calcium, Chloride, Cholesterol, Cholesterol, HDL, CO2, Creatine Kinase (CK), Creatinine, Gamma-Glutamyltransferase, Glucose, Iron, Lactate Dehydrogenase (LDH), Lipase, Magnesium, Phosphorous, Potassium, Sodium, T3 Uptake, T4 Total, Total Protein, Triglycerides, Iron-Binding Capacity, Unsaturated (UIBC), Uric Acid. |
2. Sample size used for the test set and the data provenance
- Sample Size for Test Set: Not explicitly stated with a specific number of samples. The determination of stability involves testing material over time, involving multiple aliquots and measurements.
- Data Provenance: The studies were performed by Bio-Rad Laboratories. The country of origin of the data is not specified but is presumably the USA, where Bio-Rad Laboratories is located. The studies are prospective in nature, as they involve testing the product over its claimed stability periods (e.g., real-time shelf life studies).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable. This is a quality control material where "ground truth" typically refers to the expected values and acceptable ranges for analytes, which are established through extensive analytical testing and statistical analysis, not by expert interpretation in the same way a diagnostic imaging device would be. The "ground truth" for the analytes within the control is determined by the manufacturer's reference methods and value assignment processes.
4. Adjudication method for the test set
- Not applicable. Adjudication methods (like 2+1, 3+1) are used in studies involving human interpretation or subjective assessments, generally for diagnostic accuracy. This device's performance is determined through objective laboratory measurements and statistical analysis against pre-defined stability criteria.
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 a diagnostic device that would involve human readers or AI assistance in interpreting patient data.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not applicable. This device is a physical reagent used to monitor the performance of analytical instruments. It does not employ an algorithm or AI.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- The "ground truth" for this type of device is the expected concentration/activity of each analyte within the control material, along with established stability profiles. These are determined through:
- Reference analytical methods: Using highly accurate and precise analytical techniques to assign target values to the analytes in the control.
- Statistical analysis: To define the acceptable range of variation (precision) for each analyte over its claimed shelf life and open vial stability.
- Real-time stability studies: Monitoring the material's performance over its stated shelf life and open vial periods to confirm that analyte values remain within established acceptance limits.
8. The sample size for the training set
- Not applicable. This device does not use machine learning or AI, and therefore does not have a "training set."
9. How the ground truth for the training set was established
- Not applicable. As there is no training set, this question is not relevant.
§ 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.