(31 days)
The Randox Aldolase Control Level 2 and Aldolase Control Level 3 are intended for in vitro diagnostic use as assayed quality control materials for the quantitative determination of aldolase on the clinical chemistry analyzers indicated in the package insert. This device is for prescription use only.
Randox Aldolase Control is manufactured at two levels, Level 3. Each control is prepared from human serum with added constituents of human origin, chemicals, stabilizers and preservatives. They are supplied in lyophilized form in 3x1 mL vials and require reconstitution with 1 mL of distilled water.
Here's an analysis of the acceptance criteria and the study proving the device meets them, based on the provided text:
Acceptance Criteria and Device Performance Study for Randox Aldolase Control Level 2 and Level 3
This device is a quality control material, and its performance is evaluated based on its stability and the accuracy and precision of its assigned values when used with specific clinical chemistry analyzers.
1. Table of Acceptance Criteria and Reported Device Performance
| Criteria Category | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Open Vial Stability | Aldolase must be stable for 5 days when stored at +2°C to +8°C after reconstitution, if kept capped and free from contamination. | Reconstituted Aldolase in Aldolase Controls (Level 2 and 3) was stable for 5 days when stored at +2°C to +8°C, kept capped in the original container and free from contamination. This was determined by reconstituting vials and storing them for 5 days at this temperature range. (The text only states it "was determined by" this method, implying successful stability within the specified period.) |
| Unopened Shelf Life | Aldolase Controls must be stable for 24 months when stored at +2°C to +8°C. | The Aldolase Controls (Level 2 and 3) have an assigned shelf life of 24 months. This was tested using real-time studies where three batches were stored at +2°C to +8°C for at least 24 months, and all three batches "passed real time stability testing." |
| Value Assignment - Precision (CV%) | For Aldolase concentration ≥ 10%, the CV% should be ≤ 3%. For Aldolase concentration 10 IU/L, so the ≤3% criteria applies, and 2.9% meets this.* |
Beckman Coulter AU640:
- Level 2: CV% = 3.1 (Target Value 7.67 IU/L, System Specific Value 7.79 IU/L). This level has a target value 10 IU/L, so the ≤3% applies, and 1.8% meets this.|
| Value Assignment - Range | A range is provided by taking +/- 25% of the assigned system-specific values and the consensus mean. (This describes the method for generating the range, implying that this method itself is part of the acceptance criteria for how values are presented). | The document states, "A range is also provided by taking +/- 25% of the assigned system specific values and the consensus mean," indicating this process is followed. No raw data for specific ranges is provided, but the method is stated to be used. |
2. Sample Size and Data Provenance
- Open Vial Stability Test Set: The sample size is not explicitly stated in terms of the number of vials used, but it involved "reconstituting vials of Aldolase Controls." The data provenance is internal testing by Randox Laboratories Limited in the United Kingdom. It is a prospective study assessing stability over time.
- Unopened Shelf Life Test Set: The sample size referred to is "three batches of the Aldolase controls." The data provenance is internal testing by Randox Laboratories Limited in the United Kingdom. It is a prospective (real-time) study assessing stability over 24 months.
- Value Assignment Test Set: For each level (2 and 3) on each analyzer (RX Daytona and Beckman Coulter AU640), the sample size (N) was 10 replicates. The data provenance is internal testing by Randox Laboratories Limited in the United Kingdom. This appears to be a prospective study during the value assignment process.
3. Number of Experts and Qualifications for Ground Truth
The concept of "experts" and their qualifications for establishing ground truth isn't directly applicable for a quality control material where the "ground truth" is typically a target concentration derived through a stringent, standardized "nest testing" process.
For the value assignment:
- The process involves "nest testing," where a new lot is assessed against a "master lot of controls or calibrators." While experts might oversee this, the ground truth is established through a defined analytical comparison process rather than subjective expert consensus. The "master lot" serves as the reference for truth.
- No specific number or qualification of experts is mentioned for the generation of the "master lot" or its ground truth.
4. Adjudication Method for the Test Set
Adjudication methods like 2+1 or 3+1 are typically used in clinical imaging or diagnostic studies where subjective interpretation is involved. For this device (an assayed quality control material), the "ground truth" is established through quantitative measurement and comparison to a master lot. Therefore, no multi-reader adjudication method is mentioned or relevant.
The process for value assignment involves:
- Assessment of new lots against a master lot.
- Ten replicates measured on two or more systems.
- Mean and CV calculated.
- Recovery of the master lot also measured.
This is a quantitative comparison against a known standard (the master lot/calibrator) rather than an interpretation requiring adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC comparative effectiveness study was done. This type of study is relevant for diagnostic devices that assist human readers in interpreting clinical data (e.g., medical images). The Randox Aldolase Control is a quality control material used to monitor the performance of analytical instruments; it does not involve human readers making diagnostic interpretations.
6. Standalone (Algorithm Only) Performance
This device is not an algorithm or software-only device. It is a physical assayed quality control material. Therefore, the concept of "standalone performance" for an algorithm without human-in-the-loop is not applicable. Its performance is measured by its inherent stability and its ability to yield consistent and accurate measurements (based on its assigned values) when run on clinical chemistry analyzers.
7. Type of Ground Truth Used
The ground truth for the Aldolase Controls' values is established by comparison to a master lot of controls or calibrators. This is a reference standard or traceability approach, where the "truth" is derived from established, well-characterized reference materials. The document explicitly states "Nest testing involves assessment of the new lot of controls against a master lot of controls or calibrators."
8. Sample Size for the Training Set
This document does not describe a "training set" in the context of machine learning or AI models, as this device is a chemical reagent control, not an AI or software device. If "training set" is interpreted as the data used to establish the master lot's values, that information is not provided. The data provided pertains to the verification of new lots against an already established "master lot."
9. How the Ground Truth for the Training Set Was Established
As noted above, there is no explicit "training set" in the AI/ML sense. For the master lot itself, the general industry practice for establishing the ground truth (assigned values) for such master calibrators or controls involves:
- Using highly accurate reference methods.
- Traceability to international reference standards (if available).
- Rigorous inter-laboratory studies and consensus values.
- Multiple measurements by highly skilled personnel using validated methods.
However, the provided 510(k) summary does not detail how the ground truth for the master lot itself was established, focusing instead on how new lots of the Randox Aldolase Control are assigned values relative to that master lot.
§ 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.