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510(k) Data Aggregation
(20 days)
RANDOX CYSTATIN C CONTROL LEVEL 2 RANDOX CYSTATIN C CONTROL LEVEL 3
The Randox Cystatin C Controls Level 2 and Level 3 are intended for use as assayed quality control material for monitoring the precision and accuracy of the quantitative determination of human Cystatin C by immunoturbidimetric Assays.
This in vitro diagnostic device is intended for prescription use only and can only be used by professionals.
Randox Cystatin C Controls are manufactured at two levels, Level 2 and Level 3. They are single analyte controls derived from human serum. The analyte concentrations in each control have been reviewed by a panel of experts to ensure that the concentrations are clinically relevant for use in routine hospital laboratories.
The provided text describes a 510(k) summary for the 'Randox Cystatin C Level 2 and Randox Cystatin C Level 3' controls. This document focuses on demonstrating substantial equivalence to a predicate device for regulatory approval, rather than presenting a performance study with acceptance criteria in the typical sense of a diagnostic or therapeutic device.
Therefore, many of the requested criteria for a device-proving study, such as specific performance metrics, sample sizes for test/training sets, expert adjudication methods, and MRMC studies, are not applicable to this type of submission. The 'device' here is a quality control material, not a diagnostic test providing patient results.
However, based on the information provided, here's an attempt to address the applicable points:
1. A table of acceptance criteria and the reported device performance
The submission does not explicitly define acceptance criteria as a new diagnostic device would (e.g., sensitivity, specificity thresholds). Instead, the "performance" is demonstrated by establishing its characteristics as a quality control material and showing its "similarities" to the predicate device.
| Acceptance Criteria (Implied) | Reported Device Performance (Characteristics) |
|---|---|
| Bi-level material | Manufactured at two levels (Level 2 and Level 3) |
| Intended for in vitro diagnostic use | Yes, for monitoring precision and accuracy of human Cystatin C immunoturbidimetric assays |
| Human serum matrix | Derived from human serum |
| Preserved with sodium azide | Yes, preserved with sodium azide |
| Liquid form, ready to use | Yes, provided in liquid form and ready-to-use |
| Stable up to expiry date when capped & stored at +2 to +8°C (unopened) | Stable up to expiry date when capped and stored at +2 to +8°C in the absence of contamination |
| Stable for specified period when opened | Stable for 30 days when capped in the original container at +2 to +8°C in the absence of contamination |
| Analyte concentrations clinically relevant | Analyte concentrations reviewed by a panel of experts to ensure clinical relevance |
2. Sample size used for the test set and the data provenance
- Sample Size: Not explicitly stated. The submission focuses on the characteristics of the control material (stability, matrix, preservation, etc.) rather than a performance study on a 'test set' of patient samples. Any "testing results" mentioned are implicitly related to characterizing the control material itself, not its performance against a ground truth on patient samples.
- Data Provenance: Not specified, but likely refers to internal testing and characterization conducted by Randox Laboratories Limited in the United Kingdom.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Number of experts: A "panel of experts" reviewed the analyte concentrations to ensure clinical relevance. The exact number is not specified.
- Qualifications of experts: Not specified beyond being "experts."
4. Adjudication method for the test set
- Not applicable. There isn't a "test set" of patient cases requiring adjudication as would be found in a diagnostic performance study. The expert panel's role was to review the concentrations within the control material, not to adjudicate patient results.
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 an AI-assisted diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is a quality control material, not an algorithm.
7. The type of ground truth used
- For the analyte concentrations within the control, the "ground truth" was established by a panel of experts confirming their clinical relevance. This is specific to the characteristics of the control material itself.
- For the overall device, the "ground truth" for substantial equivalence is derived from comparison to the DakoCytomation Cystatin C Control Set (K041627), the predicate device.
8. The sample size for the training set
- Not applicable. This is a quality control material, not a machine learning algorithm.
9. How the ground truth for the training set was established
- Not applicable. This is a quality control material, not a machine learning algorithm.
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