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February 2020

i-STAT Chem8+ (BLUE) : Now U.S. FDA 510(k) Cleared


Dear Valued Abbott Point of Care Customer,

As a follow up to our January 2020 letter to you, Abbott Point of Care is writing to inform you that the i-STAT CHEM8+ (bluecartridge is now U.S. FDA 510(k) cleared for use with venous and arterial whole blood samples in non-waived settings (i.e., facilities that hold a Certificate of Compliance or Accreditation). This clearance was received on February 28th, 2020.

Specifically, this clearance applies to all measured assays previously contained on the i-STAT CHEM8+ (blue) cartridge including sodium, potassium, chloride, blood urea nitrogen (BUN), ionized calcium, TCO2, glucose, creatinine and hematocrit. In addition, the i-STAT CHEM8+ (blue) cartridge continues to offer calculated measurements of anion gap and hemoglobin.

While the physical cartridge has not changed, as previously communicated, the i-STAT CHEM8+ (blue) cartridge is no longer CLIA-waived. In addition, capillary whole blood is no longer an acceptable sample type.

Abbott Point of Care has updated the i-STAT CHEM8+ (blue) cartridge product labeling accordingly, replacing the individual assay-specific Cartridge and Test Information (CTI) Sheets with one cartridge-based i-STAT CHEM8+ cartridge “Instructions for Use”, which is now available on the Abbott Point of Care website (www.pointofcare.abbott). Please note the following modifications contained within the new i-STAT CHEM8+ (blue) cartridge Instructions for Use:

  • You will find that the i-STAT CHEM8+ (blue) cartridge performance data has been updated.
  • Samples must be collected in syringes with balanced heparin or tubes with lithium heparin anticoagulant. Use of a sample collected without an anticoagulant is not supported.
  • In addition, you will see that the i-STAT CHEM8+ Instructions for Use (IFU) now includes information regarding the potential rate of Quality Check Codes (QCCs), based upon completed clinical studies.

The 510(k) clearance applies to all i-STAT CHEM8+ (bluecartridges, including any cartridges that you may already have on hand. You may use these cartridges until expiry with venous and arterial whole blood samples and in alignment with the updated Instructions for Use. Until April 30th, 2020, please continue to order i-STAT CHEM8+ (blue) cartridges using list number 09P31-25.

Next stepS

Download and review the i-STAT CHEM8+ (blue) cartridge Instructions for Use (IFU) from the Abbott Point of Care website (www.pointofcare.abbott).

If you have forwarded any i-STAT CHEM8+ (blue) cartridges to another facility, we request that you please provide a copy of this letter to them.

If you have any questions regarding this information, please contact your Abbott Point of Care Sales Specialist, Abbott Point of Care Technical Support at 1-844-256-9532 or via email at apoc_productupdates@abbott.com or visit (www.pointofcare.abbott).

Abbott Point of Care understands the recent i-STAT CHEM8+ cartridge field action created challenges for you. We sincerely apologize and are fully committed to partnering with you to achieve our shared mission of improving the quality and efficiency of care for the patients we serve.

 

Mark Klopping
DVP, US Commercial operations

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