(66 days)
Lyphochek Tumor Marker Control is intended for use as an assayed quality control serum to monitor the precision of laboratory testing procedures for the analytes listed in the package insert.
Lyphochek Tumor Marker Control is prepared from human serum with added constituents of human origin and pure chemicals. The control is provided in lyophilized form for increased stability.
Here's an analysis of the provided text regarding the Lyphochek Tumor Marker Control device, focusing on the requested criteria.
Note: The provided document is a 510(k) summary for a diagnostic control product. This type of device does not typically involve the same kind of "performance studies" (e.g., clinical trials, AI algorithm evaluations) as medical imaging devices or treatment devices. Therefore, many of the requested sections (e.g., sample size for test set, number of experts, MRMC studies, standalone performance) are not applicable in this context and cannot be answered from the provided text. The "acceptance criteria" here refer to demonstrating substantial equivalence to a predicate device for safety and effectiveness, primarily through comparing technological characteristics and intended use.
Acceptance Criteria and Device Performance for Lyphochek Tumor Marker Control
1. Table of Acceptance Criteria and Reported Device Performance
For diagnostic control products like the Lyphochek Tumor Marker Control, "acceptance criteria" are intrinsically tied to demonstrating substantial equivalence to an existing legally marketed predicate device (K983807 in this case). The primary "performance" is the ability to monitor the precision of laboratory testing procedures, which is established by having comparable characteristics and intended use to the predicate. The provided document focuses on these comparative characteristics rather than specific quantitative performance metrics as might be found for a new diagnostic assay.
| Characteristic | Acceptance Criteria (Compared to Predicate Device K983807) | Reported Device Performance (New Device: Lyphochek Tumor Marker Control) |
|---|---|---|
| Intended Use | Must be an assayed quality control serum to monitor the precision of laboratory testing procedures for listed analytes, identical to the predicate. | An assayed quality control serum to monitor the precision of laboratory testing procedures for the analytes listed in the package insert. (Identical to predicate) |
| Form | Lyophilized, identical to the predicate. | Lyophilized (Identical to predicate) |
| Matrix | Human serum, identical to the predicate. | Human serum (Identical to predicate) |
| Storage | 2-8°C, identical to the predicate. | 2-8°C (Identical to predicate) |
| Open Vial Claim | • 14 days when stored tightly capped at 2-8°C (with exceptions for ACTH, Free PSA, PSA, Calcitonin to be assayed immediately). | |
| • 30 days after reconstituting and freezing at -10°C to -20°C (with exceptions for PSA (20 days) and ACTH/Calcitonin (no frozen stability claims)). Must be identical to the predicate. | • 14 days when stored tightly capped at 2-8°C, with the following exceptions: ACTH, Free PSA, PSA and Calcitonin should be assayed immediately following reconstitution. | |
| • 30 days after reconstituting and freezing at -10°C to -20°C with the following exceptions: (1) PSA will be stable for 20 days when stored frozen at -10°C to -20°C and (2) ACTH and Calcitonin do not have frozen stability claims. (Identical to predicate) | ||
| Differences | Must not introduce new questions of safety or effectiveness. Any differences should be supported by data or demonstrate equivalency. The new device has additional analytes. | Claims for additional analytes: CA 50, CA 195, CA 549, and CASA. The implication is that the performance for these additional analytes is also acceptable as a quality control. |
2. Sample Size Used for the Test Set and Data Provenance
This information is not provided in the 510(k) summary. For a diagnostic control, the "test set" would typically refer to the data generated during validation studies to establish the stability and consistency of the control across various analytical platforms for the listed analytes. This would usually involve internal laboratory testing. The document states it is "prepared from human serum," implying human-derived components.
3. Number of Experts Used to Establish Ground Truth and Qualifications
This information is not applicable for this type of device and is therefore not provided in the 510(k) summary. For a diagnostic control, "ground truth" is established by the assigned target values and ranges for each analyte, typically determined through extensive analytical testing using reference methods and statistical analysis in a laboratory setting.
4. Adjudication Method for the Test Set
This information is not applicable for this type of device and is therefore not provided in the 510(k) summary. Adjudication methods are relevant for studies involving human interpretation or clinical outcomes, which are not the focus of a diagnostic control device.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not conducted or mentioned. This type of study is typically for evaluating the impact of a diagnostic imaging device or algorithm on human reader performance, which is not relevant for a quality control product.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop) Performance Was Done
No, a standalone performance study in the context of an "algorithm" was not done. This device is a physical control material, not a software algorithm. Its "performance" relates to its inherent stability and the accuracy/precision of its assigned values when used in laboratory instruments.
7. The Type of Ground Truth Used
The "ground truth" for a diagnostic control product like the Lyphochek Tumor Marker Control is the assigned target values and acceptable ranges for each analyte, determined through analytical methods and statistical evaluation rather than expert consensus on a clinical case or pathology findings. The summary implies these assigned values are derived from rigorous laboratory testing.
8. The Sample Size for the Training Set
This information is not applicable for this type of device in the context of machine learning or AI, and therefore not provided. The "training" for a diagnostic control involves the analytical characterization and value assignment processes in the laboratory, not a data-driven training set.
9. How the Ground Truth for the Training Set Was Established
As above, the concept of a "training set" for an AI algorithm is not applicable here. The "ground truth" (assigned values/ranges) for the control material would be established through a robust process of repeated analytical testing across multiple instruments and laboratories, using reference methods, and subjected to statistical analysis to determine the mean and standard deviation for each analyte. This process ensures the control reliably reflects known concentrations.
§ 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.