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510(k) Data Aggregation
(119 days)
The Access 25(OH) Vitamin D Total assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of total 25-hydroxyvitamin D [25(OH) vitamin D] levels in human serum and plasma using the Access 2 Immunoassay Systems. Results are to be used as an aid in the assessment of vitamin D sufficiency.
The Access 25(OH) Vitamin D Total Calibrators are intended to calibrate the Access 25(OH) Vitamin D Total assay for the quantitative determination of total 25-hydroxyvitamin D [25(OH) vitamin D] levels in human serum and plasma using the Access 2 Immunoassay Systems.
The Access 25(OH) Vitamin D Total for use on the Access 2 Immunoassay System, Access 25(OH) Vitamin D Total Calibrators for use on the Access 2 Immunoassay System, and the Access 2 Immunoassay analyzer comprise the Access Immunoassay System for the quantitative determination of total 25-hydroxyvitamin D[25(OH) vitamin D] levels in human serum and plasma.
The Access 25(OH) Vitamin D Total assay is a two-step sequential competitive binding immunoenzymatic assay. In the initial incubation, sample is added to a reaction vessel with a vitamin D binding protein (DBP) releasing agent and paramagnetic particles coated with sheep monoclonal anti-25(OH) vitamin D antibody. 25(OH) vitamin D is released from DBP and binds to the immobilized monoclonal anti-25(OH) vitamin D on the solid phase. Subsequently, a 25(OH) vitamin D analogue-alkaline phosphatase conjugate is added which competes for binding to the immobilized monoclonal anti-25(OH) vitamin D. After a second incubation, materials bound to the solid phase are held in a magnetic field while unbound materials are washed away. Then, the chemiluminescent substrate Lumi-Phos 530 is added to the vessel and light generated by the reaction is measured with a luminometer. The light production is inversely proportional to the concentration of 25(OH) vitamin D in the sample. The amount of analyte in the sample is determined from a stored, multi-point calibration curve.
The document describes the Access 25(OH) Vitamin D Total assay for use on the Access 2 Immunoassay System. This device is intended for the quantitative determination of total 25-hydroxyvitamin D levels in human serum and plasma to aid in the assessment of vitamin D sufficiency.
Here's an analysis of the acceptance criteria and the study that proves the device meets them:
1. A table of acceptance criteria and the reported device performance:
The document doesn't explicitly state "acceptance criteria" as a set of pass/fail thresholds for each metric. Instead, it presents performance characteristics from various studies, comparing them to the predicate device and in some cases, a reference method. I will infer "acceptance criteria" from typical requirements for such assays and the context of the reported results. The reported device performance is directly extracted from the "Summary of Studies" section.
| Performance Characteristic | Inferred Acceptance Criteria (Typical for IVD) | Reported Device Performance (Access 25(OH) Vitamin D Total) |
|---|---|---|
| Method Comparison (vs. Predicate) | High correlation (e.g., r > 0.90) | Correlation coefficient: 0.89 (against 279 samples, 7.48-118.83 ng/mL) |
| Method Comparison (vs. Reference Method) | High correlation and close to 1.0 slope | Slope: 1.01, Correlation coefficient: 0.95 (against 110 samples, 8.0-98.6 ng/mL) |
| Imprecision (Total CV > 15.0 ng/mL) | ≤ 10.0% | ≤ 10.0% (across studies: 5.5% to 7.5%) |
| Imprecision (Total SD ≤ 15.0 ng/mL) | ≤ 1.5 ng/mL | ≤ 1.5 ng/mL (across studies: 1.0 to 1.1 ng/mL) |
| Linearity (Measuring Range) | Linear response across the claimed range | Linear across 7.0 to 120 ng/mL |
| Limit of Blank (LoB) | Expected to be very low, below clinical significance | 1.50 ng/mL (Highest observed with no analyte: 0.55 ng/mL) |
| Limit of Detection (LoD) | Expected to be low to detect low concentrations | 2.00 ng/mL (Lowest detected with 95% probability: 1.0 ng/mL) |
| Limit of Quantitation (LoQ) | Low enough for clinical utility (e.g., %CV < 20%) | 7.0 ng/mL (Lowest with %CV of 20%: 3.0 ng/mL) |
| Analytical Specificity (Hemoglobin) | No significant interference up to a certain concentration | No interference up to 0.5 g/L |
| Analytical Specificity (Blood Constituents/Medications) | No significant interference | Normal human blood constituents and commonly encountered medications do not cause interference. |
| Cross Reactivity (Paricalcitol) | Should be noted if present | Falsely elevated results may occur in patients treated with Paricalcitol. |
| Population Observation Group (Reference Interval) | Well-defined reference interval for healthy population | 95% Reference interval: 11.9 - 43.6 ng/mL |
2. Sample sizes used for the test set and the data provenance:
- Method Comparison (vs. Predicate): 279 samples
- Method Comparison (vs. Reference Method): 110 samples
- Population Observation Group: 367 apparently healthy male and female adults.
- Provenance: Not explicitly stated beyond "human serum and plasma" and "samples from 367 apparently healthy male and female adults 21 years of age and older." It does not specify the country of origin, nor whether the data was retrospective or prospective.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This is a an in-vitro diagnostic (IVD) device, not an image-based AI device requiring expert interpretation for ground truth.
- For the Method Comparison (vs. Reference Method): The ground truth was established by the 25(OH) Vitamin D ID LC-MS/MS Reference Measurement Procedure (RMP) from Ghent University (Ghent RMP). This is a highly precise and accurate analytical method, considered a gold standard for vitamin D measurement. It doesn't involve "experts" in the sense of clinical reviewers, but rather the highly qualified personnel operating and validating such reference laboratories.
4. Adjudication method for the test set:
Not applicable in the context of an IVD assay comparing results against a predicate device or a reference measurement procedure. The comparison is quantitative, and the "ground truth" is determined by the reference method's output.
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 an in-vitro diagnostic device, not an AI-assisted diagnostic imaging device that involves human readers.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
Yes, the studies presented are for the standalone performance of the Access 25(OH) Vitamin D Total assay. The device itself is an automated immunoassay system (Access 2 Immunoassay System), which operates without continuous human "in-the-loop" decision-making, producing quantitative results directly.
7. The type of ground truth used:
- For Method Comparison against predicate: The predicate device, DiaSorin LIAISON 25 OH Vitamin D Total Assay, serves as a point of comparison (proxy for ground truth in substantial equivalence claims).
- For Method Comparison against Reference Method: The 25(OH) Vitamin D ID LC-MS/MS Reference Measurement Procedure (RMP) from Ghent University (Ghent RMP) was used as the ground truth. This is a highly accurate and precise analytical method that establishes the true concentration of the analyte.
- For Imprecision, Linearity, LoB, LoD, LoQ, Analytical Specificity, Cross Reactivity: These performance characteristics are evaluated against known concentrations (spiked samples, dilutions, or samples known to be negative/positive for interferents) controlled and measured by standard laboratory methods.
8. The sample size for the training set:
Not explicitly stated. For IVD devices, a "training set" is usually not defined in the same way as machine learning models. Instead, it refers to samples used during the assay development and optimization phases. The document focuses on validation studies.
9. How the ground truth for the training set was established:
As above, the concept of a "training set" as in AI is not directly applicable. During product development and optimization (which can be analogous to training), ground truth for establishing assay parameters (e.g., antibody concentrations, incubation times, calibration curves) would be established using:
- Known concentrations of 25(OH) vitamin D (e.g., certified reference materials).
- High-fidelity reference methods like LC-MS/MS to verify initial assay performance and calibration.
- Samples with clinically confirmed vitamin D levels.
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