# K031873: I-Stat Cardiac Markers Control Level 1, 2, and 3; Cardiac Markers Calibration Verification Control Set

- Pathway: 510(k) (Traditional)
- Applicant: I-Stat Corporation
- Decided: Oct 7, 2003 after 112 days
- Product code: JJX (Single (Specified) Analyte Controls (Assayed And Unassayed))
- Device class: 1
- Regulation: 21 CFR 862.1660
- Recalls of this device: 2 (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) More Diagnostics Cardiac Markers Control: named in the summary without a submission number

## Recalls of this device
- Dec 17, 2010 · Not classified · Z-1863-2011: Presence of CO2 in the head space of the vial can result in the generation of high results in Cardiac Marker Control Level 1, 2, and 3 which is used along with the Cardiac Marker Control Calibration V
- Dec 17, 2010 · Not classified · Z-1864-2011: Presence of CO2 in the head space of the vial can result in the generation of high results in Cardiac Marker Control Level 1, 2, and 3 which is used along with the Cardiac Marker Control Calibration V

## Indications for use
The i-STAT Cardiac Markers Controls are used to verify the integrity of newly received i-STAT cTnl cartridges. The i-STAT Cardiac Markers Calibration Verification Control Set is used to verify the accuracy of results over the measurement range of the i-STAT cTnl test.

Source page: https://510kreport.com/device/K031873
Methodology: https://510kreport.com/methodology