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510(k) Data Aggregation
(236 days)
• Elecsys Vitamin D Reagent:
The Elecsys Vitamin D assay is intended for the quantitative determination of total 25-hydroxyvitamin D in human serum and plasma. The assay is to be used as an aid in the assessment of vitamin D sufficiency in adults.
The electrochemiluminescence binding assay is intended for use on Elecsys and cobas e immunoassay analyzers.
• Elecsys Vitamin D CalSet: Elecsys Vitamin D CalSet is used for calibrating the quantitative Elecsys Vitamin D assay on the Elecsys and cobas e immunoassay analyzers.
• Elecsys PreciControl Varia 3: Elecsys PreciControl Varia 3 is used for quality control of the specified Elecsys immunoassays on the Elecsys and cobas e immunoassay analyzers.
• Elecsys Vitamin D CalCheck 5: The Elecsys Vitamin D CalCheck 5 is an assayed control for use in calibration verification and for use in the verification of the assay range established by the Elecsys Vitamin D reagent on the indicated Elecsys and cobas e immunoassay analyzers.
(1) The Elecsys Vitamin D Assay is a competitive protein binding assay which uses Vitamin D Binding Protein instead of monoclonal antibodies for detection of 25-Hydroxyvitamin D. The total duration of the assay is 27 minutes. The sample is treated with pretreatment reagent in the first incubation period. This releases any vitamin D from the endogenous vitamin D binding protein present in the patient's sample. In the next incubation, vitamin D binding protein labeled with ruthenium is added and a complex is formed between the vitamin D (25-OH) and the ruthenylated vitamin D binding protein. In the 30 and final incubation, streptavidin-coated microparticles are added along with vitamin D (25-OH) labeled with biotin. Any unbound ruthenium labeled vitamin D binding proteins become occupied with biotin-labeled vitamin D (25-OH). The complex consisting of the ruthenylated vitamin D binding protein and the biotinylated vitamin D (25-OH) becomes bound to the solid phase via interaction of the biotin and streptavidin. The reaction mixture is aspirated into the measuring cell where the electrochemiluminescence emission is detected. Results are determined using a calibration curve that is generated specifically on each instrument by a 2 point calibration provided with the reagent bar code.
(2) The Elecsys Vitamin D CalSet is a lyophilized product based on human serum. It has been standardized against LC-MS/MS, which has in turn been standardized to the NIST standard. .
(3) The Elecsys PreciControl Varia 3 is a multi-composite lyophilized 3 level control set which has been previously cleared for 7 components . The Elecsys PreciControl Varia 3 has been cleared under K111506 for the following analytes: Vitamin B12, Ferritin, Folate III, betaCrossLaps/Serum (-CTx), Osteocalcin, Parathyroid Hormone, Parathyroid Hormone Short Turnaround Time (PTH-STAT).
(4) The Elecsys Vitamin D CalCheck 5 contains 5 lyophilized levels based on human serum.
The provided document describes the Elecsys Vitamin D Assay and its associated calibrators and controls. The acceptance criteria and the study that proves the device meets the acceptance criteria are mainly focused on the Elecsys Vitamin D Assay itself, with comparisons to a predicate device and LC-MS/MS.
Here's a breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
The document doesn't explicitly state "acceptance criteria" in a separate section with numerical targets. Instead, it presents "Labeled Performance Characteristics" which serve as the performance specifications the device aims to meet. The comparison to the predicate device and LC-MS/MS provides evidence of its performance.
| Performance Characteristic | Acceptance Criteria (Implied / Predicate) | Elecsys Vitamin D Assay Performance |
|---|---|---|
| Measuring Range | Predicate: 13-96 ng/mL | 5-60 ng/mL (This is a key difference, indicating a wider lower range for the Elecsys) |
| Precision (Within-run) | Predicate: 3.1% CV @ 23.0 ng/mL, 2.6% CV @ 42.5 ng/mL, 1.4% CV @ 75.4 ng/mL | Elecsys 2010/cobas e 411 (n=84, human sera):7.2% CV @ 6.2 ng/mL5.1% CV @ 11.2 ng/mL2.9% CV @ 23.2 ng/mL2.4% CV @ 45.3 ng/mL1.6% CV @ 52.6 ng/mL |
| Precision (Total) | Predicate: 4.0% CV @ 23.0 ng/mL, 3.2% CV @ 42.5 ng/mL, 2.7% CV @ 75.4 ng/mL | Elecsys 2010/cobas e 411:10.3% CV @ 6.2 ng/mL7.6% CV @ 11.2 ng/mL5.3% CV @ 23.2 ng/mL3.4% CV @ 45.3 ng/mL2.9% CV @ 52.6 ng/mL |
| Analytical Sensitivity | Predicate: Limit of Blank: 1.9 ng/mL, Limit of Detection: 3.1 ng/mL, Limit of Quantitation (LoQ): 8.0 ng/mL | Limit of Blank (LoB): 2.00 ng/mLLimit of Detection (LoD): 3.00 ng/mLLimit of Quantitation (LoQ): 5.00 ng/mL (Lower LoQ than predicate) |
| Analytical Specificity (Cross Reactivity) | Predicate cross-reactivity percentages for various Vitamin D metabolites (e.g., 25-hydroxyvitamin D3: 105%, 25-hydroxyvitamin D2: 82%, 24,25-hydroxyvitamin D3: 112%, 1,25-hydroxyvitamin D3: 12.6%) | Elecsys cross-reactivity percentages:25-hydroxyvitamin D3: 100%25-hydroxyvitamin D2: 92%24,25-hydroxyvitamin D3: 149%1,25-hydroxyvitamin D3: not detected1,25-hydroxyvitamin D2: not detectedVitamin D3: not detectedVitamin D2: not detectedC3-epimer of 25-hydroxyvitamin D3: 91% |
| Method Comparison (vs. LC-MS/MS) | N/A (Comparison with a Gold Standard for traceability) | Deming (n=290): Slope: 1.03, Intercept: -3.07, r: 0.85 |
| Method Comparison (vs. Predicate) | N/A (Comparison with the predicate device to demonstrate substantial equivalence) | Deming (n=165): Slope: 0.99, Intercept: 1.20, r: 0.91 |
| Hook Effect | Predicate: Unknown | There is no high-dose hook effect since the Elecsys Vitamin D assay is a competitive assay. |
| Interference | Predicate: Unaffected by Hemoglobin <200 mg/dL, Bilirubin up < 20 mg/dL, Triglycerides < 5000 mg/dL, HAMA<1000 ng/mL, Rheumatoid Factor <400 IU/mL. (Biotin not tested) | Unaffected by:• Hemoglobin < 2 g/L (<2000 mg/dL)• Bilirubin up ≤ 66 mg/dL• Lipemia < 400 mg/dL• Biotin < 70 ng/mL• HAMA and Rheumatoid factors were not assessed because the assay does not utilize antibodies (This is a difference in assay design) |
2. Sample Size Used for the Test Set and the Data Provenance
- Sample Size for Method Comparison (Test Set Data):
- Versus LC-MS/MS: n=290 (for Deming regression analysis)
- Versus Predicate (Abbott Architect 25-OH Vitamin D assay): n=165 (for Deming regression analysis)
- Precision Studies: n=84 (human sera for Within-run and Total precision)
- Data Provenance: The document does not explicitly state the country of origin or whether the data was retrospective or prospective. Given it's a clinical assay submission, the samples would typically be human biological samples.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
- The document does not mention the use of experts to establish ground truth for the test set in the context of reader studies for image analysis or similar diagnostic interpretations. Instead, for the analytical performance of the vitamin D assay, the "gold standard" or reference method (LC-MS/MS) serves as the ground truth for method comparison. Experts would be involved in performing and interpreting LC-MS/MS results, but their specific number and qualifications are not detailed here.
4. Adjudication Method (for the test set)
- Not applicable. This is an in vitro diagnostic (IVD) assay and not an imaging device that requires human expert adjudication for interpretation. The performance is assessed against reference methods (LC-MS/MS) and comparisons to the predicate device.
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 device is an automated in vitro diagnostic assay (Vitamin D assay) and does not involve human readers for interpretation, nor does it incorporate AI for diagnostic assistance. Therefore, an MRMC study is not relevant.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Yes, the performance characteristics provided (Measuring Range, Precision, Sensitivity, Specificity, Method Comparison, Hook Effect, Limitations) represent the standalone performance of the Elecsys Vitamin D Assay as an algorithm/device without human-in-the-loop diagnostic interpretation. The assay is intended for use on Elecsys and cobas e immunoassay analyzers, which are automated systems.
7. The Type of Ground Truth Used
- Method Comparison: The primary ground truth for the analytical accuracy of the Elecsys Vitamin D Assay is LC-MS/MS (Liquid Chromatography-Mass Spectrometry), which is stated to be traceable to the NIST (National Institute of Standards and Technology) standard. This is considered a highly accurate and standardized reference method for measuring vitamin D.
- Precision, Sensitivity, Specificity, etc.: For these performance characteristics, the "ground truth" is established through carefully controlled experimental protocols using known concentrations of analytes, spiked samples, and characterized human sera/plasma.
8. The Sample Size for the Training Set
- The document does not explicitly state the sample size used for a "training set." For an IVD assay like this, development typically involves internal studies to optimize reagents and calibration, but the term "training set" is more commonly associated with machine learning models. The presented data represents validation studies, which are analogous to a test set in machine learning. However, the document does mention different sample sizes for different studies (e.g., n=290 for LC-MS/MS comparison, n=165 for predicate comparison, n=84 for precision).
9. How the Ground Truth for the Training Set Was Established
- As mentioned above, the concept of a "training set" with ground truth establishment in the machine learning sense is not directly applicable here. The development of reagents and assays involves iterative optimization and validation against known standards and reference methods. The assay is standardized against LC-MS/MS, which is standardized to the NIST standard, implying that the fundamental accuracy is rooted in these established reference measurement procedures and materials.
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