(35 days)
An assayed quality control serum to monitor the precision of laboratory testing procedures for 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 acceptance criteria and study for the Lyphochek® Tumor Marker Control.
Important Note: The provided document is a 510(k) Summary, which is a premarket notification for a medical device. It's meant to demonstrate substantial equivalence to a legally marketed predicate device, not necessarily a comprehensive clinical study report. Therefore, some of the requested information (like multi-reader multi-case studies, effect sizes of AI assistance, detailed expert qualifications, or extensive training set information) is typically not found in this type of submission for this specific device. The device itself is a quality control serum, not an AI-powered diagnostic tool.
Acceptance Criteria and Reported Device Performance
1. Table of Acceptance Criteria and Reported Device Performance
For a quality control serum, "acceptance criteria" usually refer to the stability claims that the product must meet to be considered effective for its intended use. The "reported device performance" is how the device actually performs against these claims during stability studies.
| Acceptance Criterion (Claim) | Reported Device Performance (as demonstrated by stability studies) |
|---|---|
| Open Vial Stability (2-8°C): | Met: |
| - All analytes stable for 14 days. | - All analytes stable for 14 days when stored tightly capped at 2-8°C. |
| - Exceptions: | - Exceptions: |
| - Ferritin and CA 27-29 stable for 6 days. | - Ferritin and CA 27-29 stable for 6 days. |
| - ACTH, Free PSA, PSA, and Calcitonin should be assayed immediately following reconstitution. | - ACTH, Free PSA, PSA, and Calcitonin should be assayed immediately following reconstitution. |
| - (Predicate: Ferritin and CA 27-29 stable for 14 days) | |
| Reconstituted Freeze-Thaw Stability (-10°C to -20°C): | Met: |
| - All analytes stable for 30 days. | - All analytes stable for 30 days when stored tightly capped at -10°C to -20°C. Once thawed, do not refreeze; discard remaining material. |
| - (Predicate: PSA stable for 20 days; ACTH and Calcitonin no frozen stability claims) | |
| Shelf Life (Unopened, 2-8°C): | Met: |
| - Control stable for 3 years and 3 months. | - Control stable for 3 years and 3 months when stored unopened at 2-8°C. (Real-time studies are ongoing to support shelf life.) |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document does not specify a numerical sample size for the stability studies. It states "Stability studies have been performed to determine the open vial stability and shelf life for the Lyphochek® Tumor Marker Control." The nature of these studies typically involves multiple vials across different lots and time points, but the exact number is not provided.
- Data Provenance: The studies were conducted by Bio-Rad Laboratories ("All supporting data is retained on file at Bio-Rad Laboratories"). The country of origin for the data is implicitly the United States, given Bio-Rad's location (Irvine, California) and the submission to the U.S. FDA. The studies are prospective in nature, as they involve testing the product over time to establish stability claims.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This information is not applicable to this type of device and study. The "ground truth" for a quality control material's stability isn't established by expert consensus or interpretation of images; rather, it's determined through analytical testing using validated methods to measure analyte concentrations over time and under various storage conditions. The "ground truth" is the actual measured concentration, and the acceptance criteria define the acceptable deviation from the initial measurement.
4. Adjudication Method for the Test Set
This is not applicable to this type of device and study. Adjudication methods like "2+1" or "3+1" are typically used in clinical trial settings where subjective interpretations (e.g., image reading) need to be resolved. For stability studies involving quantitative chemical measurements, the data is typically analyzed statistically against predetermined analytical criteria, not through expert adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size of AI Improvement
This information is not applicable. The Lyphochek® Tumor Marker Control is a quality control serum used to monitor the precision of laboratory testing procedures (e.g., for tumor marker assays). It is not an AI-powered diagnostic device, nor does it involve human readers interpreting images or data that would typically be subject to MRMC studies or AI assistance.
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 material, not an algorithm.
7. The Type of Ground Truth Used
As mentioned in point 3, the "ground truth" in this context refers to the analytical measurements of analyte concentrations over time and under specific storage conditions. These measurements are performed using validated laboratory methods on the control material. The stability claims are then established based on whether these measurements remain within pre-defined acceptable ranges over the claimed duration.
8. The Sample Size for the Training Set
This information is not applicable. Quality control materials typically undergo stability testing rather than having a "training set" in the machine learning sense. The initial formulation and characterization might involve many experiments, but it's not analogous to an AI training set.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable for the reasons stated in points 3 and 8. The "ground truth" for the performance of the control material is established through rigorous analytical testing and adherence to good manufacturing practices (GMP) and quality system regulations (QS).
§ 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.