# K051433: I-Stat Creatine Kinase MB (CK-MB)

- Pathway: 510(k) (Traditional)
- Applicant: I-Stat Corporation
- Decided: Dec 15, 2005 after 197 days
- Product code: MYT (Biosensor, Immunoassay, Cpk Or Isoenzymes)
- Device class: 2
- Regulation: 21 CFR 862.1215
- Recalls of this device: 4 (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) CK-MB test, Triage Cardiac Panel for use on the Triage Meter: 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.
- Feb 1, 2012 · Class II · Z-2171-2012: The frequency of suppressed results for i-Stat cTnl, BNP and CK-MP cartridges is affected by atmospheric pressure.
- Jan 1, 2008 · Not classified · Z-0317-2011: 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.
- Jan 1, 2008 · Not classified · Z-0318-2011: 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.

## Indications for use
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).

Source page: https://510kreport.com/device/K051433
Methodology: https://510kreport.com/methodology