(191 days)
The Triage® BNP Test is intended for use with the Triage® Meter for the rapid in vitro quantitative measurement of B-Type Natriuretic (BNP) in human capillary whole blood, venous whole blood or plasma specimens using EDTA as the anticoagulant. The test is used as an aid in the diagnosis and assessment of scverity of congestive heart failure (also referred to as heart failure). The test also is used for the risk stratification of patients with acute coronary syndromes.
The Triage® BNP Test is intended for use with the Triage® Meter for the rapid in vitro quantitative measurement of B-Type Natriuretic Peptide (BNP) in human capillary whole blood, venous whole blood or plasma specimens using EDTA as the anticoagulant. The test is used as an aid in the diagnosis and assessment of severity of congestive heart failure (also referred to as heart failure). The test also is used for the risk stratification of patients with acute coronary syndromes.
Here's an analysis of the provided text regarding the Triage® B-Type Natriuretic Peptide (BNP) Test, structured according to your requested information:
1. Table of Acceptance Criteria and the Reported Device Performance
The provided text focuses on the equivalence of capillary whole blood samples to venous whole blood samples for the Triage® BNP Test, rather than specific diagnostic accuracy acceptance criteria (e.g., sensitivity, specificity, AUC). Therefore, the acceptance criteria are related to the comparability of these sample types.
| Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|
| Statistical Equivalence: No significant difference (p |
§ 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.”