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510(k) Data Aggregation
(120 days)
VIDAS® NT-proBNP assay is an automated quantitative test for use on the VIDAS instruments for the determination of N terminal fragment of B-type natriuretic peptide in human serum or plasma (lithium heparin) using the ELFA (Enzyme-Linked Fluorescent Assay) technique. The VIDAS NT-proBNP test is used as an aid in the diagnosis of suspected congestive heart failure.
The VIDAS® NT-proBNP assay is an automated quantitative test for use on the VIDAS instruments for the determination of N terminal fragment of B-type natriuretic peptide in human serum or plasma (lithium heparin) using the ELFA (Enzyme-Linked Fluorescent Assay) technique. The VIDAS NT-proBNP test is used as an aid in the diagnosis of suspected congestive heart failure.
The assay principle combines a one-step immunoassay sandwich method with a final fluorescent detection (ELFA). The Solid Phase Receptacle (SPR), a pipette tip-like device, serves as the solid phase as well as the pipetting device for the assay. The assay reagents are ready-to-use and pre-dispensed in the sealed reagent strips (STRs). The individual kit components are described in detail in the 510(k) and in the package insert.
All of the assay steps are performed automatically by the VIDAS instrument. The sample is transferred into the well containing anti-NT-proBNP antibody (conjugate) labeled with alkaline phosphatase. The sample/conjugate mixture is cycled in and out of the SPR several times. This operation enables the antigen to bind with the immunoglobulins fixed to the interior wall of the SPR and the conjugate to form a sandwich. Unbound compounds are eliminated during washing steps.
Two detection steps are performed successively. During each step, the substrate (4-Methylumbelliferyl phosphate) is cycled in and out of the SPR. The conjugate enzyme catalyzes the hydrolysis of this substrate into a fluorescent product (4-Methyl-umbelliferone) the fluorescence of which is measured at 450 nm. The intensity of the fluorescence is proportional to the concentration of antigen present in the sample.
At the end of the assay, results are automatically calculated by the VIDAS instrument in relation to two calibration curves corresponding to the two detection steps stored in memory, and then printed out.
Here's a breakdown of the acceptance criteria and study details for the VIDAS® NT-proBNP Assay, based on the provided 510(k) summary:
1. Table of Acceptance Criteria and Device Performance
The acceptance criteria are not explicitly stated as pass/fail thresholds in the document, but rather demonstrated through comparison to the predicate device and established analytical/clinical performance figures. The reported device performance is directly from the provided text.
| Criteria Category | Specific Criterion | Predicate Device Performance [Elecsys proBNP] | VIDAS® NT-proBNP Assay Performance |
|---|---|---|---|
| Analytical Performance | |||
| Precision | Repeatability (intra-run) | 1.8 – 2.7%CV | 1.5 – 2.8 %CV |
| Inter-site precision | Not explicitly stated, total precision: 2.2 – 3.2%CV | 3.4 – 5.1 %CV | |
| Inter-lot precision | Not explicitly stated | 3.5 – 8.4 %CV | |
| Detection Limits | Lower Limit of Detection (LoD) | 5 pg/mL | < 20 pg/mL (LoD = 6.7 pg/mL) |
| Measurement Range | 5-35,000 pg/mL | 20-25,000 pg/mL | |
| Interfering Substances | Bilirubin tolerance | 35 mg/dl | 30 mg/dl (510 µmol/L) |
| Hemoglobin tolerance | 1.4 g/dl | 485 mg/dl (300 µmol/L) | |
| Triglycerides tolerance | 4000 mg/dl | 30 g/l | |
| Albumin tolerance | Not tested | 100 g/L | |
| Human IgG tolerance | Not tested | 17 g/L | |
| Human IgM tolerance | Not tested | 6 g/L | |
| Rheumatoid Factors tolerance | 1500 IU/mL | 1500 IU/mL | |
| Analytical Specificity | Adrenomedullin cross-reactivity | <0.001% | <0.1% |
| Aldosterone cross-reactivity | <0.001% | <0.1% | |
| Angiotensin I cross-reactivity | <0.001% | <0.1% | |
| Angiotensin II cross-reactivity | <0.001% | <0.1% | |
| Angiotensin III cross-reactivity | <0.001% | <0.1% | |
| ANP28 cross-reactivity | <0.001% | <0.1% | |
| Arg-Vasopressin cross-reactivity | <0.001% | <0.1% | |
| BNP32 cross-reactivity | <0.001% | <0.1% | |
| CNP22 cross-reactivity | <0.001% | <0.1% | |
| Endothelin cross-reactivity | <0.001% | <0.1% | |
| NT-proANP1-30 cross-reactivity | <0.001% | <0.1% | |
| NT-proANP31-67 cross-reactivity | <0.001% | <0.1% | |
| NT-proANP79-98 cross-reactivity | <0.001% | <0.1% | |
| Renin cross-reactivity | <0.001% | <0.1% | |
| Urodilatin cross-reactivity | <0.001% | <0.1% | |
| Drug Interference | Number of drugs tested | Not explicitly stated, "commonly used pharmaceuticals" | 39 frequently administered drugs tested in vitro (no interference observed) |
| Hook Effect | Maximum concentration without hook effect | 300,000 pg/mL | 500,000 pg/mL |
| Clinical Performance | |||
| Sensitivity (All Sites Combined, All patients) | Aid in diagnosis of suspected congestive heart failure. Performance should be comparable to predicate. | Not explicitly stated (predicate data provided for different age/gender groups with various sensitivities) | 91.89% (88.76-94.21% CI) |
| Specificity (All Sites Combined, All patients) | Aid in diagnosis of suspected congestive heart failure. Performance should be comparable to predicate. | Not explicitly stated (predicate data provided for different age/gender groups with various specificities) | 92.94% (89.98-95.08% CI) |
Acceptance Criteria: The underlying acceptance criterion for many of these performance metrics is "substantial equivalence" to the predicate device (Elecsys proBNP Assay). This means that the VIDAS® NT-proBNP Assay's performance should be similar enough to the predicate that it can be considered equally safe and effective for its intended use. For quantitative measures like precision, detection limits, and interfering substances, the performance reported for the VIDAS assay generally falls within acceptable ranges or is comparable to, or better than, the predicate. For clinical sensitivity and specificity, the provided confidence intervals are presented as the device's performance, implying they are considered acceptable given the context of aiding in diagnosis.
2. Sample Size Used for the Test Set and Data Provenance
- Reference Group (without CHF): 411 patients
- Disease Group (with CHF): 407 patients
- Total Patients in Clinical Study: 818 patients
- Data Provenance: The study was conducted at multiple sites in the US and Europe. The data is prospective in nature, as it involves the testing of the new device on patient samples collected for the purpose of evaluating its performance for aid in diagnosis.
3. Number of Experts Used to Establish the Ground Truth and Qualifications
The document does not explicitly state the number of experts used to establish the ground truth for the clinical test set, nor does it specify their qualifications (e.g., radiologist with 10 years of experience). The ground truth for Congestive Heart Failure (CHF) diagnosis would typically be established by clinical cardiologists or other medical specialists based on a comprehensive evaluation including patient history, physical examination, imaging (e.g., echocardiogram), and other laboratory tests, but these specifics are not provided in this summary.
4. Adjudication Method for the Test Set
The document does not specify any adjudication method (e.g., 2+1, 3+1, none) used for establishing the ground truth of the clinical diagnoses in the test set.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
This is a diagnostic assay (medical device) that measures a biomarker (NT-proBNP) in human serum or plasma. It is not an AI-powered diagnostic imaging tool or a system involving human readers interpreting images. Therefore, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study focusing on how human readers improve with AI vs. without AI assistance is not applicable to this type of device and was not performed.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance)
The VIDAS® NT-proBNP Assay is an automated quantitative test. The performance data presented (analytical and clinical sensitivity/specificity) represents the standalone performance of the device without human interpretation of the assay results in a way that would alter the quantitative outcome. Clinicians use the numerical result from the assay, potentially in conjunction with cut-off values, to aid in diagnosis. So, in essence, the reported performance is the "algorithm only" performance for this type of test.
7. Type of Ground Truth Used
The ground truth used for the clinical study was the clinical diagnosis of Congestive Heart Failure (CHF), as determined by healthcare professionals, differentiating between a "Reference Group (without CHF)" and a "Disease Group (with CHF)".
8. Sample Size for the Training Set
The document does not explicitly mention a separate "training set" or its sample size. For an IVD assay like this, development typically involves internal validation and optimization using various sets of characterized samples (some of which might be considered "training"), but the premarket notification focuses on the performance of the finalized assay on independent clinical samples.
9. How the Ground Truth for the Training Set Was Established
As no specific training set is outlined, the method for establishing its ground truth is not provided. However, it can be inferred that any samples used during method development (analogous to a training phase) would also rely on established clinical diagnoses for CHF, similar to the clinical test set.
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