(270 days)
StatusFirst™ CHF (Congestive Heart Failure) NT-proBNP is a rapid test for the in vitro quantitative determination of N-terminal pro-Brain natriuretic peptide (NT-proBNP) in human EDTA plasma. The device is intended for use with the DXpress™ Reader to provide quantitative results as an aid in the diagnosis of CHF.
The StatusFirst™ CHF NT-proBNP test device utilizes biotin coupled anti-NTproBNP antibody/streptavidin solid-phase chromatographic immunoassay technology to quantitatively determine the concentration of NT-proBNP in human EDTA plasma. After a sample has been dispensed into the sample well, the StatusFirst™ CHF NTproBNP test device is placed in the DXpress™ Reader. The DXpress™ Reader displays the NT-proBNP concentration 15 minutes after sample addition. The DXpress™ Reader is programmed to automatically convert the intensity of the test band (as indicated by the "pBNP" line on the test device) into a concentration of NTproBNP by using lot specific calibration factors supplied with each box of 20 StatusFirst™ CHF NT-proBNP test devices. The NT-proBNP concentration in the sample correlates with the intensity of the test band.
The provided document describes a 510(k) premarket submission for the StatusFirst™ CHF NT-proBNP device, which measures NT-proBNP levels for aid in CHF diagnosis. The study described is a method comparison study intended to demonstrate substantial equivalence to a predicate device, the Roche Elecsys® proBNP Immunoassay.
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Acceptance Criteria and Reported Device Performance
The document doesn't explicitly list "acceptance criteria" in a pass/fail format with specific thresholds. Instead, it presents the results of a method comparison study against a predicate device, aiming to demonstrate substantial equivalence. The "reported device performance" is primarily shown through the correlation between the StatusFirst™ device and the predicate.
| Acceptance Criteria (Implied by Substantial Equivalence to Predicate) | Reported Device Performance (StatusFirst™ CHF NT-proBNP vs. Elecsys® proBNP) |
|---|---|
| Good correlation for CHF subjects (compared to predicate) | Spearman Rank correlation: 0.922 (n = 324) |
| Good correlation for non-CHF subjects (compared to predicate) | Spearman Rank correlation: 0.948 (n = 324) |
| Good correlation for all subjects combined (compared to predicate) | Spearman Rank correlation: 0.973 (n = 648) |
| Agreement in measuring range (though predicate has wider range, the functional range of the new device should be clinically useful and comparable) | StatusFirst™ Measuring Range: 20-5,000 pg/mL |
| Elecsys® proBNP Measuring Range: 5-35,000 pg/mL (StatusFirst™ falls within a relevant clinical range) | |
| Functional Sensitivity (comparable to predicate) | StatusFirst™ Functional Sensitivity: 20 pg/mL |
| Elecsys® proBNP Functional Sensitivity: |
§ 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.”