(88 days)
The ADVIA Centaur® Vitamin D Total (VitD) assay is for in vitro diagnostic use in the quantitative determination of total 25(OH)vitamin D in human serum and plasma (EDTA, lithium heparin, sodium heparin) using the ADVIA Centaur® systems. The ADVIA Centaur® VitD assay is intended as an aid in the determination of vitamin D sufficiency.
The ADVIA Centaur® Vitamin D reagent kit comes in two configurations (100 or 500 test kit) and each kit contains the following:
- ReadyPack® primary reagent pack containing ADVIA Centaur VitD Lite Reagent, Solid . Phase Reagent, and Ancillary Well Reagent
- ReadyPack ancillary pack containing ADVIA Centaur VitD Ancillary Reagent .
- . ADVIA Centaur VitD Low Calibrator
- . ADVIA Centaur VitD High Calibrator
- ADVIA Centaur systems VitD Master Curve card ●
- ADVIA Centaur systems VitD Calibrator Assigned Value Card ●
The VitD Reagents consists of the following:
Lite Reagent 5.0 mL/reagent pack:
The reagent contains anti-VitD (monoclonal mouse) antibody labeled with acridinium ester (~0.8 µg/mL) in buffer with bovine serum albumin, mouse IgG, and sodium azide (
The provided text describes the performance characteristics of the ADVIA Centaur® Vitamin D Total (VitD) assay and compares it to a predicate device. It primarily focuses on the analytical performance of the device and does not involve AI or human readers in the context of diagnostic interpretation.
Here's the breakdown of the information requested, based on the provided text:
1. A table of acceptance criteria and the reported device performance
| Performance Characteristic | Acceptance Criteria (Design Goal) | Reported Device Performance |
|---|---|---|
| Precision (Within-Run CV) | ≤ 8% for samples > 20 ng/mL | 2.3% - 6.4% |
| Precision (Total CV) | ≤ 12% for samples > 20 ng/mL | 3.6% - 9.6% |
| Detection Limit (LoB) | N/A (not explicitly stated as an acceptance criterion) | 1.7 ng/mL (4.3 nmol/L) |
| Detection Limit (LoD) | Detected with 95% probability | 3.20 ng/mL (8.0 nmol/L) |
| Detection Limit (LoQ) | Total CV of 20% | 4.2 ng/mL (10.5 nmol/L) |
| Linearity | N/A (not explicitly stated as an acceptance criterion) | 4.2 to 150 ng/mL |
| Method Comparison | N/A (not explicitly stated as an acceptance criterion, but implies strong correlation to comparable assay) | y = 1.03 (x) + 0.85 ng/ml, r = 0.99 (compared to a comparable assay) |
| Specimen Equivalence | N/A (not explicitly stated as an acceptance criterion, but implies strong correlation to serum) | Correlation coefficient (r) = 0.99 for all tested tube types vs. serum |
| Dilution Recovery | N/A (not explicitly stated as an acceptance criterion, but implies recovery between 90-110%) | 97.0% to 109.0% (mean 101.0%) |
| Reference Interval | Confirmation of established reference interval | Observed values for adult (7.4-44.0 ng/mL) and pediatric (11.4-45.8 ng/mL) populations were established. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Precision: 6 samples, each assayed twice a day in replicates of 2, over 20 days (n=80 replicates per sample). Data provenance not specified.
- Method Comparison: 126 samples (118 native, 8 contrived). Data provenance not specified.
- Specimen Equivalence: 66 native and 8 contrived matched set samples (total 74 matched sets) for serum, SST, Lithium Heparin, Sodium Heparin, K2 EDTA, K3 EDTA. Data provenance not specified.
- Dilution Recovery: 5 serum samples. Data provenance not specified.
- Reference Interval:
- Adult population: 291 apparently healthy male and female subjects of light and dark skin types, aged 21-93 years.
- Pediatric population: 237 male and female subjects of light and dark skin types; 32 subjects (1-3 years), 114 subjects (3-12 years), 91 subjects (12-21 years).
- Data Provenance: Samples collected in different seasons and from different geographical regions of the United States. This indicates prospective recruitment for this specific study, though the general term "established" could imply previous work.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This report describes an in vitro diagnostic (IVD) assay for quantitative measurement, not an AI diagnostic imaging device that requires expert interpretation. Therefore, the concept of "experts used to establish the ground truth" in the way it applies to diagnostic imaging is not relevant here. The ground truth for this device is chemically and analytically determined concentrations of Vitamin D.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. This is an analytical performance study of an IVD assay, not a study involving human interpretation of diagnostic data needing adjudication.
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 document describes an IVD assay, not AI software for diagnostic interpretation.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Yes, the studies described are standalone performance evaluations of the ADVIA Centaur® Vitamin D Total (VitD) assay. The device measures Vitamin D levels, and its performance is assessed analytically (precision, linearity, detection limits, method comparison) without human intervention in the result determination process.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The ground truth for the analytical performance studies (precision, linearity, limit of detection/quantitation, method comparison) is based on:
- Known concentrations: For studies like linearity, samples are prepared with known relative concentrations.
- Established reference methods: For method comparison, the device's results are compared against a "comparable assay" (which likely serves as a reference or a well-characterized method). For traceability, it mentions "ID-LC-MS/MS 25(OH)vitamin D (RMP)," indicating a highly accurate reference method.
- Statistical definitions: LoD and LoQ are defined statistically (e.g., 95% probability of detection, 20% total CV).
- Clinical populations: For establishing reference intervals, samples are drawn from defined healthy adult and pediatric populations, and inclusion criteria (normal values for PTH, calcium, TSH, no high-dose vitamin D supplements) are used to define the reference population.
8. The sample size for the training set
This document describes the validation of an IVD assay, not a machine learning model. Therefore, there is no "training set" in the context of AI/ML. The device's operational parameters are presumably set during development and optimized based on various experiments, but these are not referred to as a "training set" in the sense of AI.
9. How the ground truth for the training set was established
Not applicable, as there is no "training set" in the context of an AI/ML model for this IVD assay.
§ 862.1825 Vitamin D test system.
(a)
Identification. A vitamin D test system is a device intended for use in clinical laboratories for the quantitative determination of 25-hydroxyvitamin D (25-OH-D) and other hydroxylated metabolites of vitamin D in serum or plasma to be used in the assessment of vitamin D sufficiency.(b)
Classification. Class II (special controls). Vitamin D test systems must comply with the following special controls:(1) Labeling in conformance with 21 CFR 809.10 and
(2) Compliance with existing standards of the National Committee on Clinical Laboratory Standards.