I-STAT Creatine Kinase MB (CK-MB)

• • Terminated Z-0761-2020 FDA Class II ·initiated 16 Oct 2019 ·via K051433, on the same 510(k)

  i-STAT cTnI blue cartridges may generate a higher than expected number of quality check codes. The observed rate of quality check codes could be in the 3 to 5% range.

• • Terminated Z-2171-2012 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.

• 2 recalls, same reason

  • Terminated Z-0317-2011 FDA Unclassified (pre-2012) ·initiated 1 Jan 2008 ·via K051433, on the same 510(k)
  • Terminated Z-0318-2011 FDA Unclassified (pre-2012) ·initiated 1 Jan 2008 ·via K051433, 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

K051433 ↗

FDA Product Code

MYT

Device Class

Class II

Regulation

21 CFR Part 862.1215

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 B-Type Natriuretic Peptide (Bnp)

  Class II

  FDA 510(k) K053597 Active Cleared 21 Jul 2006

• I-Stat 200 Portable Clinical Analyzer Open recall

  Class II

  FDA 510(k) K940918 Active Cleared 10 May 1994

See all devices from I-Stat Corp. →

• What clinical condition is the I-STAT CK-MB test primarily used to evaluate, and how does it help in diagnosis?

  The I-STAT CK-MB test is designed to quantitatively measure CK-MB mass in whole blood or plasma, which is a marker for myocardial infarction (heart attack). By detecting elevated levels of CK-MB, clinicians can assess whether a patient is experiencing cardiac damage, helping to confirm or rule out a heart attack at the point of care.

• Is the I-STAT CK-MB cartridge reusable, or is it intended for single-use only?

  The I-STAT CK-MB cartridge is explicitly designed for single-use only. It is supplied sterile and ready for immediate use in a handheld analyzer system, ensuring no risk of cross-contamination or degradation of results from repeated use.

• How is the I-STAT CK-MB cartridge supplied, and what preparation is required before testing?

  The cartridge is supplied sterile and pre-packaged for point-of-care use. No additional preparation beyond applying the sample (whole blood or plasma) is required—it is ready for immediate testing in the handheld I-STAT analyzer system.

• What regulatory pathway was followed for FDA clearance of the I-STAT CK-MB, and what does this mean for its reliability?

  The I-STAT CK-MB received FDA clearance through a Traditional 510(k) pathway, classified under Clinical Chemistry and determined to be Substantially Equivalent to a predicate device. This means it underwent rigorous review by the FDA’s Cardiovascular Panel (CH) to ensure safety, effectiveness, and reliability for detecting CK-MB levels in cardiac evaluations.