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General product information only, drawn from FDA records. It is not medical advice and does not interpret any individual result.
Short answer
The i-STAT is a portable blood analyzer from Abbott Point of Care, used with single-use test cartridges that run on two to three drops of whole blood. FDA clearance summaries describe it as an in vitro diagnostic system for trained professionals at the point of care or in a clinical laboratory, for prescription use only. Which analytes it measures depends on the cartridge.
Definition and scope
Per the FDA 510(k) summary for the i-STAT CG4+ cartridge (K244014, read 2026-11-07), the i-STAT 1 System is an in vitro diagnostic device for the quantitative determination of various clinical chemistry tests in whole blood. The system has four parts: the portable i-STAT 1 analyzer, single-use disposable i-STAT cartridges, liquid quality control and calibration verification materials, and accessories (downloader/recharger, electronic simulator, printer). Newer FDA records also name an i-STAT Alinity System for some cartridges.
The analyzer is designed to run only i-STAT cartridges. It belongs to the family of point-of-care testing devices, alongside tools such as the HemoCue and the CoaguChek.
How the system works
According to the K244014 summary, each cartridge contains sensors, a fluid pack (calibrant pouch), a sample entry well with closure, fluid channels and a waste chamber. A transfer device applies two to three drops of whole blood to the cartridge. Fluid movement, timing and heating are automated by the analyzer’s embedded software. For the CHEM8+ cartridge, the K210958 summary states a result within approximately 2 minutes.
Cartridge families in FDA records
The openFDA 510(k) database (read 2026-11-07) lists 52 records with “i-STAT” in the device name, from 1991 to 2026, under Abbott Point of Care Inc. and its predecessor I-Stat Corp. The rows below are a selection read directly from that database; each row is what the record is cleared for, not a statement of what is stocked or sold.
| Cartridge | 510(k) | Decision date | Product code |
|---|---|---|---|
| Crea | K261039 | 2026-06-26 | CGL |
| hs-TnI (Alinity System) | K253051 | 2026-06-11 | MMI |
| CG4+ | K244014 | 2025-05-02 | CHL |
| hs-TnI (i-STAT 1) | K240984 | 2025-01-03 | MMI |
| TBI (Alinity System) | K234143 | 2024-03-27 | QAT |
| CG8+ | K230275 | 2023-10-27 | JGS |
| G3+ | K223857 | 2023-09-15 | CHL |
| PTplus | K220282 | 2023-07-14 | GJS |
| CHEM8+ | K210958 | 2021-08-13 | CGA |
One cartridge, two classifications
openFDA classification data (read 2026-11-07) shows that a single cartridge can fall under several product codes. Blood gas and pH electrodes (CHL, 21 CFR 862.1120) are Class II, sodium ion-specific electrodes (JGS, 862.1665) are Class II, and enzymatic lactate (KHP, 862.1450) is Class I. The CG4+ record accordingly lists Class II for its blood gas and pH measurements and Class I for lactate.
Where it matters for labs and clinics
Because the system is cleared for point-of-care or clinical laboratory use, the same device can sit under bedside or central-lab oversight. Quality control for such devices is a documented-program question; see IQCP for the individualized quality control plan framework. FDA’s CLIA analytes-waived list (read 2026-11-07) lists no i-STAT cartridge, so this page makes no waived-test claim; the general concept is explained under CLIA-waived test.
FAQ
How accurate is an i-STAT?
Accuracy is not a single yes-or-no figure. In the K244014 summary, the FDA-reviewed evidence included precision studies designed per CLSI EP05-A3, a 20-day aqueous study and a multi-site study at three point-of-care sites, plus whole-blood precision and method comparison. The numbers are in the tables of each cartridge’s 510(k) summary, which are public at accessdata.fda.gov and differ by analyte.
What equipment is used to test blood?
It depends on the test. A handheld cartridge analyzer such as the i-STAT is one category; central-laboratory analyzers, blood gas analyzers and single-analyte meters are others. The i-STAT system is defined by its components: analyzer, cartridges, liquid controls and calibration verification materials, and accessories.
How much does an Abbott i-STAT cost?
FDA 510(k) records carry no price. Price is set by Abbott and its distributors, so no figure is given here.
What does the i-STAT test for?
It depends on the cartridge. The FDA summaries state that CHEM8+ is intended for sodium, potassium, chloride, ionized calcium, glucose, blood urea nitrogen, creatinine, hematocrit and total carbon dioxide in arterial or venous whole blood. CG4+ is intended for pH, PO2 and PCO2 in arterial, venous or capillary whole blood, and lactate in arterial or venous whole blood. Other cartridges in the table are named for creatinine, high-sensitivity troponin I, PT and traumatic brain injury (TBI). For the blood gas side of this territory see what a blood gas analyzer is; for clotting time see activated clotting time.
Common misunderstandings
- “ISTAT” is not always the analyzer. The search term also matches the Italian national statistics institute, which has nothing to do with blood testing.
- Alinity i STAT troponin is a different product. “Alinity i STAT High Sensitivity Troponin-I” (K202525, K230994) is an Abbott laboratory immunoassay, not an i-STAT point-of-care cartridge. The i-STAT hs-TnI cartridge (K240984, K253051) is a separate record.
- One analyzer does not mean one test. The analyzer runs only i-STAT cartridges, but each cartridge has its own intended use, specimen types and clearance.
- Point of care does not mean unregulated. The summaries describe prescription use by trained medical professionals.
Sources
- openFDA 510(k) and classification APIs, api.fda.gov/device/510k.json and /device/classification.json, read 2026-11-07.
- FDA 510(k) summary K244014 (i-STAT CG4+), accessdata.fda.gov/cdrh_docs/pdf24/K244014.pdf, read 2026-11-07.
- FDA 510(k) summary K210958 (i-STAT CHEM8+), accessdata.fda.gov/cdrh_docs/pdf21/K210958.pdf, read 2026-11-07.
- FDA CLIA analytes waived database, accessdata.fda.gov/scripts/cdrh/cfdocs/cfClia/analyteswaived.cfm, read 2026-11-07.
