ARCHITECT STAT High Sensitivity Troponin-I

FDA 510(k) K191595 · Abbott Laboratories Diagnostics Division

Substantially Equivalent

510(k) numberK191595

Submission

Device name
ARCHITECT STAT High Sensitivity Troponin-I
Applicant
Abbott Laboratories Diagnostics Division
Abbott Park, IL, US
Received
June 17, 2019
Decision date
September 13, 2019
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
MMI – Immunoassay Method, Troponin Subunit
Device class
Class II (moderate risk)
Regulation
21 CFR 862.1215
Specialty
Clinical Chemistry

Other 510(k)s with product code MMI

510(k)DeviceApplicantDecision
K253051i-STAT hs-TnI cartridge with the i-STAT Alinity SystemMMI · Traditional Abbott Point of Care, Inc.06/11/2026SE
K252393VITROS Immunodiagnostic Products hs Troponin I Reagent PackMMI · Traditional Ortho-Clinical Diagnostics, Inc.10/29/2025SE
K243483Access hsTnIMMI · Traditional Beckman Coulter, Inc.08/01/2025SE
K242870Access hsTnIMMI · Traditional Beckman Coulter, Inc.06/16/2025SE
K240984i-STAT hs-TnI cartridge with the i-STAT 1 SystemMMI · Traditional Abbott Point of Care, Inc.01/03/2025SE
K241165Atellica® IM High-Sensitivity Troponin I (TnIH)MMI · Traditional Siemens Healthcare Diagnostics, Inc.07/25/2024SE
K231974PATHFAST®hs-cTnI-IIMMI · Traditional Phc Corporation03/20/2024SE
K222881Access hsTnIMMI · Traditional Beckman Coulter, Inc.12/18/2023SE
K230648Access hsTnIMMI · Traditional Beckman Coulter, Inc.12/04/2023SE
K230994Alinity i STAT High Sensitivity Troponin-IMMI · Special Abbott Laboratories Diagnostics Division05/04/2023SE

More from Abbott Laboratories Diagnostics Division

510(k)DeviceDecision
K240468Alkaline PhosphataseCJE · Special 10/16/2024SE
K230994Alinity i STAT High Sensitivity Troponin-IMMI · Special 05/04/2023SE
K202525Alinity i STAT High Sensitivity Troponin-IMMI · Traditional 05/19/2022SE

Questions and answers

When was ARCHITECT STAT High Sensitivity Troponin-I cleared by the FDA?

ARCHITECT STAT High Sensitivity Troponin-I (K191595) received a 510(k) decision of Substantially Equivalent on September 13, 2019, 88 days after the submission was received.

What is the product code of K191595?

The FDA product code is MMI – Immunoassay Method, Troponin Subunit, a Class II (moderate risk) device regulated under 21 CFR 862.1215.