510(k) Report

510(k) · Cleared

Recalled · Class II · 2019

I-Stat Creatine Kinase MB (CK-MB)

K051433510(k) TraditionalCleared Dec 15, 2005197-day reviewClass II21 CFR 862.1215Recalls 4

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

I-Stat Corporation · MYT Biosensor, Immunoassay, Cpk Or Isoenzymes

Cleared on Dec 15, 2005 after a 197-day review. The FDA summary names its predicate without a number. It has been recalled 4 times.

Decided
Dec 15, 2005
Review
197 days
Class
Class II
Product code
MYT
Recalls
4
Predicates
0

The FDA summary names its predicate without a number.

FIG. 1 — Lineage of K051433Source: FDA 510(k) database · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in MYT? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

  • Candidate predicates for a device like this, rankedin the report
  • Recall history across each candidate’s familyin the report
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What was it cleared against? (1)

Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.

TypeNumberDeviceApplicantDecidedRecalls
*—CK-MB test, Triage Cardiac Panel for use on the Triage Meter
Named without a submission number
—

What descends from it?

No later submission names this one as a predicate yet.

Has anything in its family been recalled? (0 Class I)

Recalls of this device

DateClassRecallRoot causeReason
Oct 16, 2019Class IIZ-0761-2020Device Designi-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.
Feb 1, 2012Class IIZ-2171-2012Device DesignThe frequency of suppressed results for i-Stat cTnl, BNP and CK-MP cartridges is affected by atmospheric pressure.
Jan 1, 2008Not classifiedZ-0317-2011Otheri-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.
Jan 1, 2008Not classifiedZ-0318-2011Otheri-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.

No ancestor or descendant has a Class I recall.

How does its category compare?

All MYT devices

MYT Biosensor, Immunoassay, Cpk Or Isoenzymes: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · MYT

FDA has decided no MYT device since 2007.

Median 510(k) review, days · MYT

Too few MYT 510(k)s in any year since 2007 to give a median.

Recalls per year · MYT

No recall names MYT since 2007.

Adverse event reports per year · MYT

1in 2015

2015: 1
2007high 1 (2015) · low 0 (2007)2025

MAUDE reports naming product code MYT, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—00
20080—00
20090—00
20100—00
20110—00
20120—00
20130—00
20140—00
20150—01
20160—00
20170—00
20180—00
20190—00
20200—00
20210—00
20220—00
20230—00
20240—00
20250—00
20260—0—

What is it indicated for?

The i-STAT Cardiac Troponin I (cTnI) test is an in vitro diagnostic test for the quantitative measurement of cardiac troponin I in whole blood or plasma. Measurements of cardiac troponin I are used in the diagnosis and treatment of myocardial infarction and as an aid in the risk stratification of patients with acute coronary syndromes wit respect to their relative risk of mortality.

The i-STAT CKMB test is an in vitro diagnostic test for the quantitative measurement of creatinine kinase MB mass in whole blood or plasma samples. CK-MB measurements can be used as an aid in the diagnosis and treatment of myocardial infarction (MI).

Indications for use as stated in the FDA summary.

More from I-Stat Corporation

7 FDA decisions under this applicant name. See the company

  • K053597I-Stat B-Type Natriuretic Peptide (BNP)I-Stat Corporation · 20062 recalls
  • K053110Abbott i-STAT Crea Cartridge, Abbott i-STAT G Cartridge, Abbott i-STAT 6+ Cartridge, Abbott i-STAT EC4+…I-Stat Corporation · 20063 recalls
  • K031873I-Stat Cardiac Markers Control Level 1, 2, and 3; Cardiac Markers Calibration Verification Control SetI-Stat Corporation · 20032 recalls
  • K023582I-Stat Kaolin Act TestI-Stat Corporation · 20032 recalls
  • K031739I-Stat Cardiac Troponin (Ctni) TestI-Stat Corporation · 20035 recalls

Recent decisions in MYT

The MYT category page

  • K033155Biocentrex Cardiac PanelBiocentrex · 2004
  • K984433Quantech CK-MB AssayQuantech, Ltd. · 1999

https://510kreport.com/device/K051433 · printed Nov 6, 2026

Cite this page

510(k) Report. “K051433: I-Stat Creatine Kinase MB (CK-MB).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K051433

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Record history
  • FDA decision record loaded May 2, 2026
  • Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
  • Page last updated Nov 3, 2026