Abbott i-STAT Crea Cartridge, Abbott i-STAT G Cartridge, Abbott i-STAT 6+ Cartridge, Abbott i-STAT EC4+ Cartridge, Abbott i-STAT E3+ Cartridge— 510(k) K053110

Clearance details

Applicant

I-Stat Corporation

Product code

Code JGS

Device class

Class 2

Regulation

21 CFR 862.1665

Advisory panel

Clinical Chemistry

Date received

2005-11-04

Decision date

2006-01-13

Decision

Substantially Equivalent

Clearance type

Special

Location

East Windsor, NJ, US

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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
• K023582 — I-STAT KAOLIN ACT TEST2003-09-08
• K031739 — I-STAT CARDIAC TROPONIN (CTNI) TEST2003-09-02

Malfunction

535

Total

535

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-1846-2025 — ABBOTT POINT OF CARE TEST CREA I-STAT (25/BX) ABBTPT CARTRIDGE.Class II·Ongoing·Mckesson Medical-Surgical Inc. Corporate Office·20250424

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K053110.