(117 days)
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. This test, in conjunction with other known risk factors, can also be used to predict survival in patients after myocardial infarction. 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 ADVIA Centaur® System. This assay is indicated for the measurement of plasma BNP as an aid in the diagnosis of and assessment of the severity of heart failure. This test, in conjunction with other known risk factors, can also be used to predict survival in patients after myocardial infarction. 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, which use constant amounts of two monoclonal antibodies. The first antibody, in the Lite Reagent, is an acridinium ester labeled monoclonal mouse anti-human BNP F(ab')2 fragment specific to the ring structure of BNP. The second antibody, in the Solid Phase, is a biotinylated monoclonal mouse antihuman antibody specific to the C-terminal portion of BNP, which is coupled to streptavidin magnetic particles. Patient sample (calibrator or control materials) is incubated for 5 minutes at 37°C with the Reagent that contains 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 BNP in the sample and the two antibody conjugates. Following incubation, the unbound antibody conjugates are washed away. The chemiluminescence of the immuno-complex signal is measured in a fuminometer. Samples with low BNP levels 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 amount of relative light units (RLUs) detected by the system.
The provided text describes a 510(k) premarket notification for the ACS:180® and ADVIA Centaur® BNP Assays by Bayer Diagnostics. The document establishes substantial equivalence to a predicate device (ADVIA Centaur® B-Type Natriuretic Peptide (BNP) Assay, K031038) and discusses the assays' technological and performance characteristics.
Here's an analysis of the acceptance criteria and study information provided, structured according to your request:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state "acceptance criteria" for performance metrics in a pass/fail format. However, it presents the "Performance Characteristics" of the proposed devices, which implicitly serve as the demonstrated performance that FDA found substantially equivalent to the predicate device. These performance characteristics cover various analytical aspects of the assay. Since the document states "The following table compares the performance characteristics of the current and proposed Bayer ADVIA Centaur and ACS:180 BNP assays," and the values listed under "Proposed Bayer ADVIA Centaur® and ACS:180® BNP Immunoassays" are identical to "Current Bayer ADVIA Centaur® and ACS:180® BNP Immunoassays," it implies that the new devices meet the established performance of the predicate device.
| Performance Characteristic | Acceptance Criteria (Implied by Predicate Performance) | Reported Device Performance (Proposed Devices) |
|---|---|---|
| Precision (ADVIA Centaur) | Within-run: 1.8 – 4.3 %CV (29.4 to 1736 pg/mL) | Within-run: 1.8 – 4.3 %CV (29.4 to 1736 pg/mL) |
| Total: 2.3 - 4.7 %CV (29.4 to 1736 pg/mL) | Total: 2.3 - 4.7 %CV (29.4 to 1736 pg/mL) | |
| Precision (ACS:180) | Within-run: 2.5 - 7.9%CV (51.5 to 1783 pg/mL) | Within-run: 2.5 - 7.9%CV (51.5 to 1783 pg/mL) |
| Total: 3.8 - 9.9%CV (51.5 to 1783 pg/mL) | Total: 3.8 - 9.9%CV (51.5 to 1783 pg/mL) | |
| Hook Effect | No high dose effect up to 100,000 pg/mL | No high dose effect up to 100,000 pg/mL |
| Analytical Sensitivity (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.”