# K031739: I-Stat Cardiac Troponin (Ctni) Test

- Pathway: 510(k) (Traditional)
- Applicant: I-Stat Corporation
- Decided: Sep 2, 2003 after 90 days
- Product code: MMI (Immunoassay Method, Troponin Subunit)
- Device class: 2
- Regulation: 21 CFR 862.1215
- Recalls of this device: 5 (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) Dade Behring Stratus CS Cardiac Troponin I TestPak: named in the summary without a submission number

## Recalls of this device
- Oct 16, 2019 · Class II · Z-0761-2020: 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.
- Nov 1, 2012 · Class II · Z-0716-2013: APOC has determined that 10 boxes of i-Stat cTnI cartridges from lot P12179 have an incorrect barcode applied to the cartridge portion pack.
- Mar 7, 2012 · Class II · Z-2237-2012: Abbott Point of Care has determined that i-Stat CTNL cartridges have the potential to exhibit incorrectly elevated cardiac troponin I results. This recall was expanded on July 19 2012 to include addit
- Feb 1, 2012 · Class II · Z-2169-2012: The frequency of suppressed results for i-Stat cTnl, BNP and CK-MP cartridges is affected by atmospheric pressure.
- Sep 29, 2011 · Not classified · Z-0180-2012: i-Stat cTnI cartridges beginning with letter "T" may exhibit a higher than expected variability in reported results. This increased variability may result in falsely elevated or falsely depressed resu

## Indications for use
The i-STAT Cardiac Troponin I (cTnl) test is an in vitro diagnostic test for the quantitative measurement of cardiac troponin I in heparinized 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 their relative risk of mortality.

Source page: https://510kreport.com/device/K031739
Methodology: https://510kreport.com/methodology