# K053597: I-Stat B-Type Natriuretic Peptide (BNP)

- Pathway: 510(k) (Traditional)
- Applicant: I-Stat Corporation
- Decided: Jul 21, 2006 after 210 days
- Product code: NBC (Test, Natriuretic Peptide)
- Device class: 2
- Regulation: 21 CFR 862.1117
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) BNP test for use on the Biosite Triage® Meter: named in the summary without a submission number
- (no number) Triage® BNP Calibration Verification Controls: named in the summary without a submission number

## Recalls of this device
- Feb 1, 2012 · Class II · Z-2170-2012: The frequency of suppressed results for i-Stat cTnl, BNP and CK-MP cartridges is affected by atmospheric pressure.
- Jan 1, 2008 · Not classified · Z-0319-2011: i-Stat cartridges may not fill, cartridge labels or channels may appear discolored, cartridges may have fluid visible in the cartridge channel, and cartridge packaging may be distended.

## Indications for use
The i-STAT BNP test is an in vitro diagnostic test for the quantitative measurement of B-Type Natriuretic Peptide (BNP) in whole blood or plasma samples using EDTA as the anticoagulant. BNP measurements can be used as an aid in the diagnosis and assessment of the severity of congestive heart failure. The i-STAT BNP Controls are assayed liquid plasma used to verify the integrity of newly received i-STAT BNP cartridges. The i-STAT BNP Calibration Verification Controls are assayed liquid plasma used to verify the calibration of i-STAT BNP cartridges throughout the reportable range.

Source page: https://510kreport.com/device/K053597
Methodology: https://510kreport.com/methodology