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510(k) Data Aggregation
(11 days)
The NTP method is an in vitro diagnostic assay for the quantitative measurement of N-terminal pro-brain natriuretic peptide (NT-proBNP) in human serum and plasma on the Dimension® EXLTM integrated chemistry system with LOCI® Module. In individuals suspected of having congestive heart failure (CHF), measurements of NT-proBNP are used as an aid in the diagnosis and assessment of severity. The test is further indicated for the risk stratification of patients with acute coronary syndrome and heart failure.
The EXL NTP method is a one-step sandwich chemiluminescent immunoassay based on LOCI® technology, LOCI® reagents include two synthetic bead reagents and a biotinylated monoclonal antibody fragment which recognize an epitope located in the N-terminal part of proBNP. The first bead reagent (Sensibeads) is coated with streptavidin and contains photosensitive dye. The second bead reagent (Chemibeads) is coated with a second antibody specific for a second independent epitope on NTproBNP and contains chemiluminescent dye. Sample is incubated with Chemibeads and biotinylated antibody to form a particle/NT-proBNP/biotinylated antibody sandwich. Sensibeads then are added and bind to the biotin to form a bead-aggregated immunocomplex. Illumination of the complex by light at 680 nm generates singlet oxygen from Sensibeads, which diffuses to the Chemibeads and triggers a chemiluminescent reaction. The resulting chemiluminescent signal is measured at 612 nm and is directly proportional to the concentration of NT-proBNP in the sample.
Here's a breakdown of the acceptance criteria and study information for the Dimension® EXL™ NTP Flex® Reagent Cartridge (RF623), based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
The document establishes substantial equivalence by comparing the performance characteristics of the Dimension® EXL™ NTP Flex® Reagent Cartridge (RF623) to its predicate device, the Dimension Vista® PBNP Flex® reagent cartridge (K6423A). For each characteristic, the acceptance criterion is implicitly the performance of the predicate device, which the new device matches.
| Feature | Acceptance Criteria (Predicate Device Performance) | Reported Device Performance (Dimension® EXL™ NTP Flex® RF623) |
|---|---|---|
| Intended Use | Quantitative measurement of N-terminal pro-brain natriuretic peptide (NT-proBNP) in human serum and plasma for diagnosis and assessment of CHF severity, and risk stratification for acute coronary syndrome and heart failure. | Matches predicate's intended use (see detailed description in the document). |
| Device Technology | Chemiluminescent | Chemiluminescent |
| Measuring Range | 5 - 35,000 pg/mL | 5 - 35,000 pg/mL |
| Antibody | Monoclonal Sheep Antibody | Monoclonal Sheep Antibody |
| Cut-off | 125 pg/mL for < 75 years old; 450 pg/mL for ≥ 75 years old | 125 pg/mL for < 75 years old; 450 pg/mL for ≥ 75 years old |
| Analytical Sensitivity | ≤5 pg/mL | ≤5 pg/mL |
| Functional Sensitivity | ≤30 pg/mL | ≤30 pg/mL |
| Analytical Specificity | No significant cross-reactivity with Natrecor® (0 or 125 pg/mL NT-PBNP) and sixteen other substances. | No significant cross-reactivity with Natrecor® (0 or 125 pg/mL NT-PBNP) and sixteen other substances. |
| Interferences | No significant interference from: Bilirubin conjugated up to 60 mg/dL, Bilirubin unconjugated up to 60 mg/dL, Hemoglobin up to 1000 mg/dL, Triglyceride up to 3000 mg/dL. | No significant interference from: Bilirubin conjugated up to 60 mg/dL, Bilirubin unconjugated up to 60 mg/dL, Hemoglobin up to 1000 mg/dL, Triglyceride up to 3000 mg/dL. |
| Hook Effect | No effect up to 400,000 pg/mL | No effect up to 400,000 pg/mL |
| Calibration Interval | 30 days, same reagent lot | 30 days, same reagent lot |
| Sample Volume | 8 µL | 8 µL |
Study Proving Device Meets Acceptance Criteria:
The document states: "Comparative testing performed by Siemens Healthcare Diagnostics Inc. demonstrates substantial equivalent performance." This indicates that a study was conducted to show the new device performs comparably to the predicate device across the characteristics listed above.
2. Sample Size Used for the Test Set and Data Provenance:
The document does not explicitly state the sample size used for the comparative testing. It also does not specify the data provenance (e.g., country of origin, retrospective or prospective nature of the sample collection).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
This information is not provided in the document. For an in vitro diagnostic (IVD) test measuring a biomarker like NT-proBNP, the "ground truth" for the test results themselves would typically be the measurement obtained from a calibrated reference method or the predicate device, not necessarily established by human experts in the same way as, for example, image interpretation. However, the ground truth for the clinical conditions (CHF, acute coronary syndrome) mentioned in the intended use would be established by medical experts (e.g., cardiologists, emergency physicians) based on clinical evaluation, imaging, and other diagnostic tests. The document does not detail how the clinical ground truth for any patient samples used in the "comparative testing" was established, nor the qualifications of those experts.
4. Adjudication Method for the Test Set:
This information is not provided in the document. Given that this is a comparison to a predicate device for an IVD, the "adjudication method" would likely refer to how discrepancies between the new device and predicate device measurements (if any) were resolved, or how the clinical diagnosis as "ground truth" was confirmed, but this is not detailed.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size:
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is relevant for devices involving human interpretation (e.g., imaging AI). This device is an in vitro diagnostic assay with quantitative output, so an MRMC study is not applicable. The device's "improvement" is in its performance matching the predicate, not in improving human reader performance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
Yes, the performance evaluated is inherently "standalone" in the context of an IVD. The "comparative testing" would have assessed the performance of the Dimension® EXL™ NTP Flex® Reagent Cartridge (RF623) directly against the Dimension Vista® PBNP Flex® reagent cartridge (K6423A) without human intervention in the measurement process itself, beyond operating the instruments. The output is a quantitative value from the device.
7. The Type of Ground Truth Used:
The ground truth for the device's performance is implicitly the results obtained from the legally marketed predicate device (Dimension Vista® PBNP Flex® reagent cartridge (K6423A)). The document doesn't mention the use of pathology, or direct outcomes data as the primary ground truth for establishing equivalence in analytical performance but rather the established performance of the predicate device.
8. The Sample Size for the Training Set:
The document does not specify a training set sample size. For an IVD like this, "training set" is not typically a concept that applies in the same way it does for machine learning algorithms that learn from data. The device's formulation (reagents, antibodies) and measurement principles are established through standard assay development, manufacturing, and validation processes, not through a "training set" in the common AI sense.
9. How the Ground Truth for the Training Set Was Established:
As mentioned above, the concept of a "training set" and associated "ground truth" for this type of IVD device is not applicable in the same way it is for AI/ML devices. The "ground truth" for the development and validation of the assay would be based on known concentrations of NT-proBNP standards and controls, as well as samples characterized by a reference method or the predicate device itself during its initial development. The current document focuses on demonstrating substantial equivalence to an existing device, which is a different regulatory pathway than initial device development.
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