Cleared Traditional

i-STAT hs-TnI cartridge with the i-STAT 1 System

K240984 · Abbott Point of Care, Inc. · Chemistry
Jan 2025
Decision
268d
Days
Class 2
Risk

About This 510(k) Submission

K240984 is an FDA 510(k) clearance for the i-STAT hs-TnI cartridge with the i-STAT 1 System, a Immunoassay Method, Troponin Subunit (Class II — Special Controls, product code MMI), submitted by Abbott Point of Care, Inc. (Princton, US). The FDA issued a Cleared decision on January 3, 2025, 268 days after receiving the submission on April 10, 2024. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1215.

Submission Details

510(k) Number K240984 FDA.gov
FDA Decision Cleared SESE
Date Received April 10, 2024
Decision Date January 03, 2025
Days to Decision 268 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF

Device Classification

Product Code MMI — Immunoassay Method, Troponin Subunit
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.1215

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