(601 days)
The ADVIA Centaur® NT-proBNPII (PBNPII) assay is for in vitro diagnostic use in the quantitative determination of N-terminal pro-brain natriuretic peptide (NT-proBNP) in human serum and plasma (EDTA and lithium heparin) using the ADVIA Centaur® XP system.
In the Emergency Department (ED) and Outpatient (OP) populations, measurements of NT-proBNP are used as an aid in the diagnosis of heart failure (HF) in patients with clinical suspicion of new onset or worsening HF.
The ADVIA Centaur® NT-proBNPII (PBNPII) assay kit includes the Primary Reagent ReadyPack and the Calibrator. The Primary Reagent ReadyPack contains Lite Reagent, Solid Phase Reagent, and Ancillary Well Reagent. The Calibrator includes Low and High Calibrators which are lyophilized.
The provided document discusses the ADVIA Centaur® NT-proBNPII (PBNPII) assay, an in vitro diagnostic device for measuring N-terminal pro-brain natriuretic peptide (NT-proBNP) to aid in the diagnosis of heart failure in Emergency Department (ED) and Outpatient (OP) populations. The submission aims to demonstrate substantial equivalence to the predicate device, the Roche Elecsys proBNP II assay (K072437).
Here's an analysis of the acceptance criteria and the studies that support them:
1. Table of Acceptance Criteria and Reported Device Performance
The document doesn't explicitly state "acceptance criteria" as a single, consolidated table with pass/fail values for all performance characteristics. Instead, it presents various performance studies with their results. Based on the "Comparison of Technological Characteristics with the Predicate Device" and the "Performance Characteristics" sections, we can infer some criteria and compare the device's performance.
| Performance Characteristic | Acceptance Criteria (Implied/Predicate) | Reported Device Performance (ADVIA Centaur PBNPII) |
|---|---|---|
| Intended Use | Aid in diagnosis of suspected congestive heart failure. | Aid in diagnosis of HF in ED and OP populations with clinical suspicion of new onset or worsening HF. |
| Measurement | Quantitative | Quantitative |
| Technology | Chemiluminescence immunoassay | Chemiluminescence immunoassay (1-step sandwich) |
| Sample Type | Plasma and Serum | Human serum, plasma (EDTA and lithium heparin) |
| Assay Range | 5-35,000 pg/mL (Predicate) | 35-35,000 pg/mL |
| Hook Effect | No hook effect up to 300,000 pg/mL (Predicate) | No hook effect up to 300,000 pg/mL (will report >35,000 pg/mL) |
| Precision (Total CV) | For Serum: e.g., |
§ 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.”