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510(k) Data Aggregation
(228 days)
RANDOX IMMUNOASSAY SPECIALITY CONTROL (II), LEVEL 1, LEVEL 2 AND LEVEL 3
The Randox Immunoassay Speciality Control (II) Levels 1, 2 and 3 are intended for in vitro diagnostic use as assayed quality control material for Calcitonin, Gastrin, and Procalcitonin to monitor the precision of the laboratory testing systems listed in the package insert. This device is for prescription use only.
Randox Immunoassay Speciality Control (II) is manufactured at three levels, Level 1, Level 2 and Level 3. Each control is prepared from human serum with added constituents of human origin, chemicals, stabilizers and preservatives. They are supplied in lyophilised form in 5x1ml vials and require reconstitution with 1ml of distilled water. The analyte concentrations in each of the three levels have been chosen to span a range that includes the chemically significant or medical decision level(s). The analyte concentrations have been reviewed by a panel of experts to ensure that the concentrations are clinically relevant for use in routine hospital laboratories.
Here's an analysis of the acceptance criteria and the study proving the device meets them, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
For this device (Randox Immunoassay Speciality Control (II) Levels 1, 2 and 3), the primary "performance" is its stability and its ability to provide consistent "value assignments" for the analytes it controls. The acceptance criteria relate to the consistency of these assigned values.
| Acceptance Criteria | Reported Device Performance/Method |
|---|---|
| Value Assignment Precision: % Coefficient of Variation (CV) for analyte value assignment | Achieved: % CV ≤ 15% for the mean value generated from 20 replicates (5 replicates per vial, 2 vials, over 2 days of analysis). This criterion ensures the consistency of the assigned values for Calcitonin, Gastrin, and Procalcitonin. |
| Open Vial Stability (Refrigerated): Procalcitonin stability | Achieved: Stable for 1 day at +2°C to +8°C if kept capped and free from contamination. This demonstrates the product's practical usability for a typical daily laboratory workflow. |
| Open Vial Stability (Refrigerated): Gastrin and Calcitonin stability | Achieved: Stable for 8 hours at +2°C to +8°C if kept capped and free from contamination. Similar to Procalcitonin, this ensures practical usability for a single work shift. |
| Open Vial Stability (Frozen): All analytes | Achieved: Stable if frozen once for 28 days at -20°C. This provides extended stability for laboratories that may need to store reconstituted controls for longer periods, reducing waste. |
| Unopened Vial Stability (Refrigerated): All analytes | Achieved: Stable to the expiration date printed on individual vials when stored at +2°C to +8°C. This is a fundamental requirement for the shelf-life of the product as a quality control material. |
| Clinical Relevance of Analyte Concentrations | Achieved: "The analyte concentrations in each of the three levels have been chosen to span a range that includes the chemically significant or medical decision level(s). The analyte concentrations have been reviewed by a panel of experts to ensure that the concentrations are clinically relevant for use in routine hospital laboratories." This ensures the control material is useful for monitoring clinically important ranges. |
| Substantial Equivalence to Predicate Device | Achieved: The general conclusion of the 510(k) submission is that "Testing results indicate that the proposed device is substantially equivalent to the predicate devices." This implies that the device performs comparably to an already legally marketed device (Biorad Lyphochek Immunoassay plus Control Levels 1, 2 and 3) in terms of its intended use, format, matrix, storage, and relevant analytes (Gastrin and Calcitonin, in particular, were compared directly). While not a direct numerical criterion, it's a key regulatory acceptance. |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Description: The "test set" in this context refers to the samples used for the value assignment study, which establishes the expected concentrations and ranges for the control material.
- Sample Size: For each analyte (Calcitonin, Gastrin, Procalcitonin), two vials of the control material were used. From these two vials, a total of 20 replicates were analyzed (5 replicates per vial, over 2 days).
- Data Provenance: The study was conducted at Randox Laboratories. The nature of the study (analyzing their own manufactured control material to establish values) implies it is an internal, prospective study aimed at characterizing the product. No specific country of origin for the underlying human serum in the control is stated beyond "human serum with added constituents of human origin." The added analytes (Calcitonin, Gastrin, Procalcitonin) have commercial origins as specified in the "Traceability" section (Sigma and Randox itself).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- Number of Experts: "A panel of experts" was used. The exact number is not explicitly stated, but the plural "experts" indicates more than one.
- Qualifications of Experts: The document states that these experts were involved in ensuring "the concentrations are clinically relevant for use in routine hospital laboratories." This implies they are likely clinical laboratory professionals, physicians, or scientists with expertise in immunoassay testing and clinical interpretation of analyte levels. Specific qualifications (e.g., years of experience, certifications) are not provided in the text.
4. Adjudication Method for the Test Set
- For Value Assignment: No explicit adjudication method (like 2+1 or 3+1 consensus) is described for the numerical value assignment. The assigned value is derived statistically as the mean of 20 replicates. The acceptance criterion for this is simply a %CV ≤ 15%.
- For Clinical Relevance: A "panel of experts" reviewed the analyte concentrations for clinical relevance. This implies a form of consensus-based "adjudication" for the appropriateness of the chosen concentration ranges, though the specific process (e.g., majority vote, discussion until agreement) is not detailed.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No MRMC comparative effectiveness study was done. This device is a quality control material, not a diagnostic device that humans interpret. Therefore, concepts like "human readers improving with AI vs. without AI assistance" are not applicable.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
- A standalone performance study was implicitly done for the value assignment. The "device" in this context is the control material itself, and its performance (assigned values and stability) was determined using laboratory analyzers and protocols as described. There isn't an "algorithm" in the typical sense for this type of device; rather, it's about the analytical performance and characteristics of the control material when measured by standard laboratory equipment. The criteria (e.g., %CV) are quantitative measures of its performance.
7. Type of Ground Truth Used
- For Value Assignment: The "ground truth" for the analyte concentrations (Calcitonin, Gastrin, Procalcitonin) is established by replication and averaging on selected analyzers according to a defined protocol, meeting a specific precision criterion (%CV ≤ 15%). This is an analytical ground truth based on repeated measurements.
- For Clinical Relevance: The "ground truth" for the appropriateness of concentration ranges for clinical use is based on expert consensus (review by a panel of experts).
8. Sample Size for the Training Set
- This information is not explicitly provided. For a quality control material, there isn't a "training set" in the sense of machine learning. The focus is on characterizing the manufactured product. The "development" or "formulation" of the control material would involve a different set of experiments, but those aren't detailed here as a "training set." The materials used for value assignment (2 vials, 20 replicates) constitute the test set for its performance characteristics.
9. How the Ground Truth for the Training Set Was Established
- As there isn't a "training set" described for this type of device, this question is not fully applicable. However, for the development of the control material itself (if we interpret "training set" loosely as the development phase leading up to the final product), the ground truth for its formulation and stability would have been established through a series of internal R&D experiments and analytical testing, likely guided by industry standards and regulatory expectations for control materials. The text only describes the validation/characterization of the final product.
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