i-STAT G3+ and CG4+ Cartridges

i-STAT G3+ Cartridge for use with iStat 1

The Abbott i-STAT G3+ and CG4+ (White) cartridges are single-use blood gas panels designed for use with the i-STAT 1 System. They provide rapid, quantitative measurement of key respiratory and acid-base parameters from a small whole blood sample, directly at the point of care. Both panels include pH, partial pressure of oxygen (PO2) and partial pressure of carbon dioxide (PCO2), with calculated values such as bicarbonate (HCO3-), total CO2 (TCO2), base excess and oxygen saturation (sO2).

The CG4+ cartridge offers the same core blood gas panel as G3+, with the addition of lactate for clinicians and laboratories that need rapid lactate assessment alongside blood gases.

In IVF and andrology settings, this cartridge may be considered for selected, laboratory-defined quality control investigations where blood gas data are useful. Any such use for IVF lab QC is off-label and must be fully validated by the laboratory.

Key test characteristics

• G3+ panel: pH, PO2, PCO2 with calculated TCO2, HCO3-, base excess and sO2 when used with a compatible i-STAT analyzer
• CG4+ panel: Same as G3+ with the addition of lactate
• Sample type: Arterial, venous or capillary whole blood
• Sample volume: Approximately 95 µL
• Typical turnaround time: Blood gas results in about 2 minutes at the bedside or point of care
• Intended instrument: i-STAT 1 System (G3+ White is FDA cleared for use with i-STAT 1 in the US)
• Format: Single-use, self-contained cartridge with integrated biosensor technology
• Kit size: Typically supplied in boxes of 25 cartridges (professional use only)

Typical clinical use

G3+ and CG4+ cartridges are intended for in vitro quantification of pH, PO2 and PCO2 in arterial, venous or capillary whole blood, with CG4+ also providing lactate. These measurements support diagnosis, monitoring and treatment of respiratory, metabolic and acid-base disturbances and conditions where lactate trends are important.

Exploratory use in IVF and andrology labs (off-label)

Although these cartridges are designed and cleared for patient blood testing, some IVF and andrology laboratories may explore their use as part of internal quality-focused activities.

Any use beyond the stated intended use - including testing non-blood matrices or using results as direct indicators of culture media or incubator performance - is off-label. IVF Store recommends that laboratories:

Perform full method validation for any off-label application, including accuracy, precision and reportable ranges

• Define in-house reference intervals and acceptance criteria where appropriate
• Confirm that such use complies with local regulations, CLIA requirements and accreditation standards

Handling and storage

• Refrigerated storage: 2–8 °C (35–46 °F) until the expiration date on the box
• Room temperature storage: 18–30 °C (64–86 °F) for the time period specified on the outer carton
• Individually pouched cartridges help protect integrity and stability before use
• Cartridges perform built-in quality checks prior to analysis to help ensure reliable results with minimal daily maintenance

Important notice about off-label use

The i-STAT G3+ and CG4+ (White) cartridges are in vitro diagnostic devices intended for use with human whole blood as described in Abbott’s official labeling. Any use within IVF or andrology laboratory quality control workflows that involves non-blood matrices or other applications outside the Instructions for Use is off-label. IVF Store supplies these cartridges as components of a clinical blood gas and lactate test system. Responsibility for validating, documenting and regulating any alternative applications rests solely with the end user.

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