(57 days)
Apolipoprotein Control Serum CHD is used as an assayed control for accuracy and precision in the quantitative immunochemical determination of Apolipoprotein A-I and B by radial immunodiffusion; Apolipoprotein A-I, All*, B, E* and CRP with the Behring Nephelometer Systems; and Apolipoprotein A-I, B and Myoglobin with the TurbiTime System™ * Reagents for these determinations are not available in USA
Apolipoprotein Control Serum CHD is a lyophilized reagent prepared from human serum with stabilizers and preservative. The product is calibrated against different protein standard preparations including in-house and commercially available reference preparations.
This submission is for a quality control material (Apolipoprotein Control Serum CHD) and therefore the typical acceptance criteria and study designs for diagnostic devices are not applicable in the same way. The primary goal is to demonstrate that the control material is substantially equivalent to an existing legally marketed predicate device. This means showing that it performs similarly and serves the same purpose as the predicate, not that it achieves a specific diagnostic performance metric.
Therefore, many of the requested categories (e.g., sample size for test/training sets, experts for ground truth, MRMC study, standalone performance) are not relevant or not present in this documentation for a quality control product.
Here's an interpretation based on the provided text for a quality control material:
1. Table of Acceptance Criteria and Reported Device Performance
For a quality control material, "acceptance criteria" revolve around its intended use and composition being substantially equivalent to a predicate device, ensuring it functions appropriately to monitor the performance of assays. "Device performance" is typically about its characteristics being consistent with or comparable to the predicate.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Intended Use: Assayed control for accuracy and precision in quantitative immunochemical determinations. | Intended Use: Assayed control for accuracy and precision in the quantitative immunochemical determination of specified apolipoproteins and CRP/Myoglobin. |
| Analytes: Comparable or expanded panel. | Analytes: Apolipoprotein A-1, AII, B, E, myoglobin, and CRP. (Note: Expanded compared to predicate which listed A-1, AII, B, E, and myoglobin). |
| Matrix: Stabilized reagent from human serum. | Matrix: Stabilized reagent from human serum. |
| Form: Lyophilized. | Form: Lyophilized. |
| Volume: 0.5 ml per vial. | Volume: 0.5 ml per vial. |
| Compatibility: Compatible with specified assay systems (Radial Immunodiffusion, Behring Nephelometer Systems, TurbiTime System™). | Compatibility: Used with Radial Immunodiffusion, Behring Nephelometer Systems, and TurbiTime System™. |
2. Sample Size Used for the Test Set and Data Provenance
Not applicable in the context of a 510(k) submission for a quality control material. There is no "test set" of patient data to evaluate diagnostic accuracy. The submission focuses on product characteristics and substantial equivalence to a predicate.
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" in this context would refer to the true values of analytes in the control material, which are established by the manufacturer through rigorous characterization and calibration, often against reference materials. This is an internal manufacturing and validation process, not a clinical expert review.
4. Adjudication Method for the Test Set
Not applicable. There is no "test set" in the diagnostic performance sense that would require expert adjudication.
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 device is a quality control material, not a diagnostic device involving human readers or AI assistance.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a biochemical control material, not an algorithm.
7. The Type of Ground Truth Used
For a quality control material, the "ground truth" for the assigned values of the analytes within the control serum is established by:
- Calibration against different protein standard preparations: This includes in-house and commercially available reference preparations.
- Assay-specific determination: The control is "assayed" for accuracy and precision in specific immunochemical determination methods, implying that the expected values are derived from testing it with the very clinical assays it is intended to control.
Therefore, the ground truth is based on calibration against reference standards and empirical determination using established assay methods, rather than clinical outcomes or pathology.
8. The Sample Size for the Training Set
Not applicable. This device is a manufactured reagent, not a machine learning algorithm that requires a "training set."
9. How the Ground Truth for the Training Set was Established
Not applicable as there is no training set for this type of device. The "ground truth" (i.e., assigned values) for the control serum is established through the manufacturer's internal calibration and characterization processes as described in point 7.
§ 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.