(128 days)
The Randox Immunoassay Speciality Control (I) Levels 1, 2 and 3 are intended for in vitro diagnostic use as assayed quality control material to monitor the precision of laboratory testing procedures for the analytes listed in the package insert. This device is for prescription use only.
Randox Immunoassay Speciality Control (I) 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 5x2ml vials and require reconstitution with 2ml 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.
The Randox Immunoassay Speciality Control (I) Levels 1, 2 and 3 is a quality control material intended to monitor the precision of laboratory testing procedures for a specific panel of analytes. The provided document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting a detailed study of the device's performance against specific acceptance criteria.
Here's an analysis based on the provided text, addressing your points where possible:
1. Table of Acceptance Criteria and Reported Device Performance
The 510(k) summary does not explicitly list "acceptance criteria" for the performance of the Randox Immunoassay Speciality Control (I) Levels 1, 2 and 3 in the way one might expect for a diagnostic test with specific sensitivity/specificity targets. Instead, the "performance" is implicitly demonstrated through substantial equivalence to a predicate device. The primary characteristics compared are functional and compositional.
| Characteristic | Acceptance Criterion (Implied by Predicate Equivalence) | Reported Device Performance (Randox Immunoassay Speciality Control (I)) |
|---|---|---|
| Intended Use | For in vitro diagnostic use as assayed quality control material to monitor the precision of laboratory testing procedures for listed analytes. | The Randox Immunoassay Speciality Control (I) is intended for in vitro diagnostic use as assayed quality control material to monitor the precision of laboratory testing procedures for the analytes listed in the package insert. |
| Matrix | Human Serum | Human Serum |
| Analytes | Comparable set of analytes in the predicate device | 1-25 OH Vitamin D, 25 OH Vitamin D, Anti TG, Anti TPO, C-Peptide, Insulin Like Growth Factor (IGF 1), Osteocalcin, Parathyroid Hormone (PTH), Insulin, Procalcitonin |
| Stability (Unopened) | Comparable to predicate device (-20 to -70°C, until expiration date) | 2 to 8 °C, Until expiration date (Note: Different storage temp. but deemed equivalent for QC material functionality) |
| Stability (Opened) | Comparable to predicate device (e.g., 30 days at 2-8°C for most analytes) | Reconstituted serum stable for 5 days at +2 to 8°C (capped) or 4 weeks frozen at -20°C. Specific analyte stabilities vary (e.g., Anti-TG for 3 days, C-Peptide, IGF-I, Procalcitonin for 1 day, Osteocalcin for 4 hours, PTH for 4 hours at 2-8°C or 2 weeks frozen). |
| Value Assignment | Reliable and traceable method for assigning values | Values assigned from a consensus of results obtained by reference laboratories using a unique statistical analysis. |
| Traceability | Source materials for analytes are known and appropriate | Suppliers and origins for each analyte are listed (e.g., synthetic, human plasma, human peptide, recombinant) |
Note: The differences in "SIZE," "FORMAT," "STORAGE (Unopened)," and "SHIPPING TEMPERATURE" are noted in the comparison table but are implicitly deemed acceptable as they do not hinder the fundamental function of the device as a quality control material. The key is that it functions as intended to monitor precision.
2. Sample Size Used for the Test Set and Data Provenance
The document does not detail a "test set" in the context of clinical or performance data for a diagnostic test. For a quality control material, the performance is primarily demonstrated through stability studies and value assignment reproducibility.
- Stability Studies: The summary provides stability claims (e.g., "5 days at +2°C to +8°C" reconstituted) but does not specify the sample size (number of vials, number of runs, etc.) or detailed methodology used to determine these stability periods.
- Value Assignment: It states that "Each batch of Immunoassay Speciality Control is submitted to a number of reference laboratories." The exact number of laboratories or the number of measurements taken for value assignment per batch are not specified.
- Data Provenance: The device is manufactured by Randox Laboratories Limited in the United Kingdom. Therefore, the internal studies for stability and value assignment would originate from the UK. The document does not specify if external data (e.g., from different countries) were used for these evaluations. These are inherent development and validation activities for the product, not typically "retrospective or prospective" studies on patient data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
For this device:
- Ground Truth for Value Assignment: The document states, "Each batch of Immunoassay Speciality Control is submitted to a number of reference laboratories and values are assigned from a consensus of results obtained by these laboratories using a unique statistical analysis." While these laboratories are "reference laboratories," the specific number of individual experts or their qualifications (e.g., years of experience, specific certifications) are not provided.
- Clinical Relevance of Concentrations: "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." The number and qualifications of these "panel of experts" are not specified.
4. Adjudication Method for the Test Set
Not applicable in the conventional sense for this type of device. There isn't a "test set" of patient cases requiring adjudication. For value assignment, a "consensus of results" from reference laboratories is used, implying an analytical agreement process rather than a clinical adjudication of a diagnosis.
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 is a quality control material, not a diagnostic imaging or AI-assisted diagnostic device. Therefore, no MRMC study or AI assistance is relevant.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a physical quality control material, not a software algorithm.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for this quality control device is established through:
- Analytical Consensus: For the assigned values of the analytes within the control material, "values are assigned from a consensus of results obtained by these (reference) laboratories using a unique statistical analysis." This relies on the analytical accuracy and precision of multiple expert reference laboratories.
- Material Composition/Concentration: The "ground truth" of what the control is (e.g., 25 OH Vitamin D from a synthetic source) is given by its manufacturing specifications and traceability data.
No pathology or outcomes data are involved as this device does not diagnose disease; it monitors the performance of other diagnostic tests.
8. The Sample Size for the Training Set
Not applicable. This is not a machine learning or AI-driven device requiring a "training set."
9. How the Ground Truth for the Training Set Was Established
Not applicable, as it's not an AI/ML device.
§ 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.