I-STAT CARDIAC TROPONIN (CTNI) TEST— 510(k) K031739

Clearance details

Applicant

I-Stat Corporation

Product code

Code MMI

Device class

Class 2

Regulation

21 CFR 862.1215

Advisory panel

Clinical Chemistry

Date received

2003-06-04

Decision date

2003-09-02

Decision

Substantially Equivalent

Clearance type

Traditional

Location

East Windsor, NJ, US

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• K053597 — I-STAT B-TYPE NATRIURETIC PEPTIDE (BNP)2006-07-21
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• K051433 — I-STAT CREATINE KINASE MB (CK-MB)2005-12-15
• K031873 — I-STAT CARDIAC MARKERS CONTROL LEVEL 1, 2, AND 3; CARDIAC MARKERS CALIBRATION VERIFICATION CONTROL SET2003-10-07
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Injury

172

Malfunction

3,762

Total

3,934

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

• Z-0761-2020 — i-STAT cTnI cartridgeClass II·Terminated·Abbott Point Of Care Inc.·20191016
• Z-0716-2013 — Abbott Point of Care i-Stat cTnI cartridge. The i-Stat cardiac troponin I (cTnI) test is an in vitro diagnostic test for the quantitive measurement of cardiac troponin I (cTnI) 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 with respect to the relative risk of mortality.Class II·Terminated·Abbott Point of Care Canada Limited·20121101
• Z-2237-2012 — i-STAT cTnI cartridges Product Usage: The i-STAT cTnl test is an in vitro diagnostic test for the quantitative measurement of cardiac troponin I in heparinized whole blood or plasma samples. Cardiac I troponin measurement cane be used as an aid in the diagnosis and treatment of myocardial infarction and in the risk stratification of patients with acute coronary syndromes with respect to their relative risk of mortality.Class II·Terminated·Abbott Point Of Care Inc.·20120307
• Z-2169-2012 — i-Stat cTnl cartridges Abbott Point of Care Inc. The i-Stat cTnl test is an in vitro diagnostic test for the quantitative measurement of cardiac troponin I in heparinized whole blood or plasma samples. Cardiac troponin I measurements can be used as an aid in the diagnosis and treatment of myocardial infarction and in the risk stratification of patients with acute coronary syndromes with respect to their relative risk of mortality. The cartridge is to be used with the i-Stat Analyzer, but not with the i-Stat Portable Clinical Analyzer or the Philips Medical System (formerly Agilent Technologies) Blood Analysis Module (BAM). As part of the i-Stat System, the cTnl test is to be used by trained health care professionals in accordance with a facility's policies and procedures.Class II·Terminated·Abbott Point Of Care Inc.·20120201

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K031739.