I-Stat B-Type Natriuretic Peptide (Bnp)

• • Terminated Z-2170-2012 FDA Class II ·initiated 1 Feb 2012

  The frequency of suppressed results for i-Stat cTnl, BNP and CK-MP cartridges is affected by atmospheric pressure.

• • Terminated Z-0319-2011 FDA Unclassified (pre-2012) ·initiated 1 Jan 2008 ·via K053597, on the same 510(k)

  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.

Recalls marked "via" name another device cleared under the same FDA submission as this one.

510(k) Number

K053597 ↗

FDA Product Code

NBC

Device Class

Class II

Regulation

21 CFR Part 862.1117

Advisory Committee

Clinical Chemistry

FDA Decision

SESE Substantially Equivalent

• Modification to: I-Stat Portable Clinical Analyzer

  Class II

  FDA 510(k) K012478 Active Cleared 20 Aug 2001

• Model 100 Portable Clinical Analyzer and Test Pack

  Class II

  FDA 510(k) K894914 Active Cleared 16 Oct 1989

• I-Stat Control Levels 1, 2, 3

  Class I

  FDA 510(k) K934641 Active Cleared 9 Dec 1993

• I-Stat Tests for Acid-Base Parameters

  Class II

  FDA 510(k) K936081 Active Cleared 24 Feb 1994

• I-Stat 200 Portable Clinical Analyzer Open recall

  Class II

  FDA 510(k) K940918 Active Cleared 10 May 1994

• I-Stat Cardiac Markers Control Level 1, 2, and 3; Cardiac Markers Calibration Verification Control Set

  Class I

  FDA 510(k) K031873 Active Cleared 7 Oct 2003

See all devices from I-Stat Corp. →