(41 days)
Lyphochek Elevated Immunosuppressant Control is intended for use as a whole blood quality control to monitor the precision of laboratory procedures for cyclosporine testing.
This product is prepared from human whole blood with added chemicals and preservatives. This product is provided in lyophilized form for added stability.
This document describes the Lyphochek Elevated Immunosuppressant Control, a quality control material for cyclosporine testing.
Here's an analysis of the acceptance criteria and the study that proves the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance
The provided summary focuses on establishing substantial equivalence to a predicate device and stability claims. It does not present specific quantitative "acceptance criteria" in terms of performance metrics (like accuracy, precision, or bias) for cyclosporine testing itself, as it is a quality control material, not a diagnostic test. Instead, the "acceptance criteria" for this device relate to its stability and its comparison to a similar existing product.
| Acceptance Criteria Category | Specific Criteria | Reported Device Performance/Status |
|---|---|---|
| Intended Use Equivalence | To be used as a whole blood quality control to monitor the precision of laboratory procedures for cyclosporine testing. (Similar to predicate) | Substantially Equivalent: Lyphochek Elevated Immunosuppressant Control is intended for the same purpose as the predicate device (Lyphochek Whole Blood Control), specifically tailored for cyclosporine. |
| Form Equivalence | Lyophilized (Similar to predicate) | Substantially Equivalent: New device is lyophilized, matching the predicate. |
| Matrix Equivalence | Processed Human Whole Blood Lysate (Similar to predicate) | Substantially Equivalent: New device uses processed human whole blood lysate, matching the predicate. |
| Preservation Equivalence | Contains preservatives (Similar to predicate) | Substantially Equivalent: New device contains a broad-spectrum anti-microbial cocktail as a preservative, similar to the predicate. (Note: New device explicitly states it does not contain sodium azide, which is a specification rather than a direct criterion match, but it still has preservatives). |
| Storage (Unopened) | 2°C to 8°C until expiration date (Similar to predicate) | Reported Performance: Three years and three months when stored at 2 to 8 °C. Study: Real-time studies are ongoing to support this claim. |
| Reconstituted Vial Claim | 14 days at 2°C to 8°C (Similar to predicate) | Reported Performance: 14 days when stored tightly capped at 2 to 8°C (Open vial Stability). Study: Stability studies performed. |
| Reconstituted and Freezing | 30 days when stored tightly capped at -10 to -20°C (Similar to predicate) | Reported Performance: 30 days when stored tightly capped at -10 to -20°C (After reconstituting and freezing). Study: Stability studies performed. |
| Safety | Preservative concentration not expected to cause a health hazard; does not contain sodium azide. | Reported Performance: Broad-spectrum anti-microbial cocktail has individual ingredient concentrations less than 0.1%, not expected to cause a health hazard. Does not contain sodium azide. This meets regulatory expectations for safety regarding preservatives at these low concentrations. |
| Substantial Equivalence | Demonstrates equivalence in terms of intended use, technological characteristics, and safety and effectiveness, despite minor differences (levels, specific analytes). | FDA Determination: FDA has determined the device is substantially equivalent to legally marketed predicate devices, allowing it to proceed to market. This implies that the differences (bi-level vs. tri-level, specific analytes other than cyclosporine) were deemed not to raise new questions of safety or effectiveness. |
2. Sample Size Used for the Test Set and the Data Provenance
The document does not explicitly state the "sample size used for the test set" in the context of typical algorithm validation (e.g., number of patient samples). The studies performed are stability studies and a comparison against a predicate device.
- Stability Studies: The "sample size" for these would refer to the number of control vials tested at various time points and storage conditions. This information is not detailed in the summary.
- Data Provenance: The studies were performed by the manufacturer, Bio-Rad Laboratories, and the data is internal to the company. The summary states "All supporting data is retained on file at Bio-Rad Laboratories." There is no mention of country of origin for the data or whether it was retrospective or prospective, other than the "real-time studies will be ongoing" for shelf life, indicating a prospective approach for that specific claim.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
This type of information is not applicable to this device. The Lyphochek Elevated Immunosuppressant Control is a quality control material, not a diagnostic device that requires expert interpretation of results or establishing a clinical ground truth. Its performance relates to its stability and its ability to consistently produce known (assigned) values for cyclosporine testing method monitoring. There are no "experts" establishing ground truth in the sense of clinical diagnosis.
4. Adjudication Method for the Test Set
This is not applicable to this device. Adjudication methods (like 2+1, 3+1) are used in clinical studies where multiple readers or experts provide interpretations that need to be resolved to form a definitive ground truth. As noted above, this device does not involve such human interpretation or ground truth establishment.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic imaging or similar devices where human readers interpret patient cases, and the AI's impact on their performance is being evaluated. The Lyphochek control is a material used to monitor an assay's precision, not a device that human readers interact with for interpretation.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was Done
N/A. This device is a physical quality control material, not an algorithm. Therefore, "standalone algorithm performance" is not a relevant concept for it.
7. The Type of Ground Truth Used
For this device, the "ground truth" (or reference value) would be the assigned value of cyclosporine within the control material, established through a robust method (e.g., highly accurate reference method or a consensus of multiple clinical analyzers). The document does not explicitly detail how these assigned values are derived or what type of "ground truth" is used for the values themselves, but rather focuses on the stability of these values over time and storage conditions. The "ground truth" for the stability claims is the manufacturer's internal criteria for acceptable variation from specified values under different conditions.
8. The Sample Size for the Training Set
This is not applicable to this device. There is no "training set" as this is not an AI/ML algorithm or a device that learns from data.
9. How the Ground Truth for the Training Set Was Established
This is not applicable for the same reason as point 8.
§ 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.