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Abbott's Blood Analysis Cartridge Gets FDA Clearance for use With Whole Blood Samples

NEW YORK – Abbott Laboratories' Blue i-Stat CG4+ cartridge recently received 510(k) clearance from the US Food and Drug Administration for use with venous and arterial whole blood samples in non-waived settings.

The blue cartridge was a modified version of Abbott's White i-Stat CG4+ cartridge, which is FDA cleared and CLIA waived. In January, the company told customers not to use the blue cartridge after noticing performance changes. Abbott had not submitted new 510(k) applications to the FDA after the modifications, but the agency requested new applications for both the Blue i-Stat CG4+ cartridge and the Blue Chem8+ cartridges.

The new FDA clearance applies to all four measured assays previously included on the cartridge, including pH and lactate, although the reportable ranges for the assays have been updated. Capillary whole blood is no longer an acceptable sample type with the cartridge. Under the clearance, whole blood samples must be collected in syringes with balanced heparin or tubes with lithium heparin anticoagulant. 

The clearance also applies to all Blue i-Stat CG4+ that were already manufactured, which can be used until previously listed expiration dates.