(151 days)
For in vitro diagnostic use in the quantitative determination of B-type Natriuretic Peptide (BNP) in human plasma using the ADVIA Centaur® System. This assay is indicated for the measurement of plasma BNP as an aid in the diagnosis and assessment of the severity of heart failure. In patients with acute coronary syndromes (ACS), this test, in conjunction with other known risk factors, can also be used to predict survival as well as to predict the likelihood of future heart failure. This assay is not intended for use on any other system.
For in vitro diagnostic use in the quantitative determination of B-type Natriuretic Peptide (BNP) in human plasma using the ACS:180® Automated Chemiluminescence System. This assay is indicated for the measurement of plasma BNP as an aid in the diagnosis and assessment of the severity of heart failure. In patients with acute coronary syndromes (ACS), this test, in conjunction with other known risk factors, can also be used to predict the likelihood of future heart failure. This assay is not intended for use on any other system.
The ACS:180 and ADVIA Centaur BNP assays are fully automated two-site sandwich immunoassays using direct chemiluminescent technology. The first antibody, in the Reagent, is an acridinium ester labeled monoclonal mouse anti-human antibody specific to the N-terminal portion of BNP. The second antibody, in the Solid Phase Reagent, is a biotinylated monoclonal mouse anti-human antibody specific to the C-terminal portion of BNP, which is coupled to streptavidin coated magnetic particles. Patient sample (calibrators or control materials) is incubated for 5 minutes at 37°C with the Solid Phase Reagent and the tracer antibody conjugate. Subsequently, Solid Phase Reagent is added and incubated for 2.5 minutes at 37°C. An immuno-complex is formed between the unbound antibody conjugates are washed away. Following incubation, the immuno-complex signal is measured in a luminometer. The chemiluminescent signal will have a minimum amount of bound AE label, while Samples with high levels of BNP will have maximum label complex bound. Thus, a direct relationship exists between the amount of BNP present in the patient sample and the relative light units (RLUs) detected by the system.
Here's an analysis of the provided text regarding the Bayer Diagnostics ADVIA Centaur BNP Assay, broken down by your requested criteria:
The provided document is a Summary of Safety and Effectiveness for the Bayer Diagnostics ADVIA Centaur BNP Assay and ACS:180 BNP Assay, primarily focusing on its updated indications for use and substantial equivalence to previously cleared devices. It describes the technological and performance characteristics but does not contain detailed study results like typical acceptance criteria tables for accuracy or precision studies against a defined benchmark. Instead, it states that the characteristics (like precision, measuring range, analytical sensitivity, etc.) are "Same" as the predicate device.
Therefore, for aspects like "reported device performance" against acceptance criteria, "sample sizes used for the test set," "number of experts," "adjudication method," "MRMC study effect size," and "standalone performance," the provided document does not contain this information. It relies on the previously cleared predicate devices for establishing performance equivalency without re-presenting the detailed studies.
Here's what can be extracted based on the information available:
1. A table of acceptance criteria and the reported device performance
The provided document does not explicitly present a table of acceptance criteria with corresponding device performance from new studies following the format typically seen for a new device's primary validation. Instead, it compares the proposed device's characteristics to a predicate device, largely stating they are "Same."
However, we can infer some "performance characteristics" that are deemed acceptable by virtue of being equivalent to the predicate.
| Characteristic | Acceptance Criteria (Implied from Predicate) | Reported Device Performance (Proposed Device) |
|---|---|---|
| Measuring Range | ADVIA Centaur: |
§ 862.1117 B-type natriuretic peptide test system.
(a)
Identification. The B-type natriuretic peptide (BNP) test system is an in vitro diagnostic device intended to measure BNP in whole blood and plasma. Measurements of BNP are used as an aid in the diagnosis of patients with congestive heart failure.(b)
Classification. Class II (special controls). The special control is “Class II Special Control Guidance Document for B-Type Natriuretic Peptide Premarket Notifications; Final Guidance for Industry and FDA Reviewers.”