510(k) K253051

i-STAT hs-TnI cartridge with the i-STAT Alinity System by Abbott Point of Care, Inc. — Product Code MMI

K253051 is an FDA 510(k) premarket notification submitted by Abbott Point of Care, Inc. for the device "i-STAT hs-TnI cartridge with the i-STAT Alinity System". The FDA issued a decision of Substantially Equivalent on June 11, 2026. The device falls under product code MMI (Immunoassay Method, Troponin Subunit), a Class II device regulated under 21 CFR 862.1215. Abbott Point of Care, Inc. has at least 10 other 510(k) clearances on record.