(22 days)
Quest Diagnostics Immunoassay/TDM Control is intended for use as a quality control serum to monitor the precision of laboratory testing procedures for the analytes listed in the package insert.
Quest Diagnostics Immunoassay/TDM Control is prepared from human serum, with added constituents of human and animal origin, chemicals, and therapeutic drugs. The control is provided in lyophilized form for increased stability.
This is a premarket notification for the Quest Diagnostics Immunoassay/TDM Control. Based on the provided document, here's an analysis of the acceptance criteria and supporting study information:
1. Table of Acceptance Criteria and Reported Device Performance
The document is a 510(k) premarket notification claiming substantial equivalence to a predicate device. For such devices, the "acceptance criteria" are generally related to demonstrating comparable performance (precision, stability) to the predicate device. The performance of the new device is typically evaluated against established ranges or specifications for each analyte, which are implicitly derived from the predicate device's expected performance and clinical utility.
The document primarily focuses on stability claims as explicit performance criteria for the new device.
| Acceptance Criteria (Stability Claims) | Reported Device Performance (Quest Diagnostics Immunoassay/TDM Control) |
|---|---|
| Open Vial Stability: Stability when stored tightly capped at 2 to 8°C. | 7 days at 2 to 8°C, with the following exceptions: |
| - C-Peptide, Folate, and PSA are stable for 3 days. | |
| - Gastrin, Free PSA, and Intact PTH should be assayed immediately after reconstitution. | |
| Shelf Life: Stability when stored at 2 to 8°C. | 36 months when stored at 2 to 8°C. |
Note: The document does not explicitly state numerical acceptance criteria for assay performance (e.g., specific coefficients of variation or bias limits). Instead, it relies on demonstrating that the new control performs equivalently to the predicate and meets its intended use as a quality control serum to monitor the precision of laboratory testing procedures for listed analytes. This equivalence is implicitly accepted by the FDA's 510(k) clearance based on the provided data.
2. Sample Size Used for the Test Set and Data Provenance
The document states: "Stability studies have been performed to determine the open vial stability and shelf life for the Quest Diagnostics Immunoassay/TDM Control. Product claims are as follows:..."
- Sample Size for Test Set: The specific sample sizes (e.g., number of control lots, number of replicates, number of instruments used) for the stability studies are not provided in this summary. It simply states "Stability studies have been performed."
- Data Provenance: The document does not explicitly state the country of origin of the data. However, the submitter is Bio-Rad Laboratories, located in Irvine, California, USA. The testing would presumably have been conducted in a facility under their control, likely in the USA. The studies are prospective as they were specifically performed to determine the stability claims for this new device.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This type of information is not applicable to a quality control material where the "ground truth" relates to the assigned values or reference ranges of the analytes within the control. For quality control materials, the "ground truth" (the expected range of values) is established through rigorous internal validation processes by the manufacturer, often using reference methods and statistical analysis rather than expert consensus on individual "cases." The intended use is to monitor the precision of laboratory tests, meaning the control's own stability and performance consistency are critical.
4. Adjudication Method for the Test Set
This is not applicable. Adjudication methods (like 2+1, 3+1) are typically used in clinical studies involving interpretation of medical images or diagnostic results where expert consensus is needed to determine the "true" clinical outcome or diagnosis for a case. For a quality control material, the performance assessment is based on analytical measurements and statistical process control, not subjective interpretation requiring adjudication among experts.
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
This is not applicable. An MRMC study is designed to evaluate the diagnostic performance of a device (often imaging-related) in an clinical setting, often comparing human interpretation with and without AI assistance across multiple readers and cases. The Quest Diagnostics Immunoassay/TDM Control is a quality control material, not a diagnostic device that requires human interpretation or AI assistance in a diagnostic workflow.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable. The device is a physical quality control serum, not an algorithm, and does not operate "standalone" in the sense of a software-only diagnostic tool. Its performance is demonstrated through its own chemical and physical stability when used within laboratory testing procedures.
7. The Type of Ground Truth Used
For a quality control material, the "ground truth" for its performance is typically:
- Analytical Measurement: The measured concentrations or activities of the analytes within the control using calibrated reference methods.
- Stability over Time: Demonstrated by empirical testing that the analyte values remain within acceptable ranges over the claimed shelf life and open-vial stability periods.
- Material Homogeneity and Consistency: Ensuring that each vial performs consistently within a lot.
The document states: "Stability studies have been performed to determine the open vial stability and shelf life for the Quest Diagnostics Immunoassay/TDM Control." This implies that the ground truth for these claims was established through prospective analytical testing and measurement of the control material over specified timeframes and storage conditions.
8. The Sample Size for the Training Set
This is not applicable. Quality control materials are manufactured and validated, not "trained" in the way an AI algorithm or machine learning model would be. There is no concept of a "training set" in this context.
9. How the Ground Truth for the Training Set was Established
As there is no "training set" for a quality control material, this question is not applicable. The underlying properties of the control material (analyte concentrations, matrix characteristics) are established during the manufacturing and formulation process, and then its performance (stability) is verified through specific studies as described above.
§ 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.