Atlas FDA

Elecsys Troponin T Gen 5

FDA 510(k) clearance K201441 · decided 2021-09-21

Clearance details

K-number
K201441
Device name
Elecsys Troponin T Gen 5
Applicant
Roche Diagnostics
Decision
Substantially Equivalent
Date received
2020-06-01
Decision date
2021-09-21
Days to decision
477 days
Clearance type
Traditional
Product code
MMI
Device class
2
Regulation number
862.1215
Medical specialty
Clinical Chemistry
Advisory committee
Clinical Chemistry
Location
Indianapolis, IN, US
Third-party review
No
Expedited review
No

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i-STAT hs-TnI cartridge with the i-STAT Alinity System (K253051)Abbott Point of Care, Inc.2026-06-11
VITROS Immunodiagnostic Products hs Troponin I Reagent Pack (K252393)Ortho-Clinical Diagnostics, Inc.2025-10-29
Access hsTnI (K243483)Beckman Coulter, Inc.2025-08-01
Access hsTnI (K242870)Beckman Coulter, Inc.2025-06-16
i-STAT hs-TnI cartridge with the i-STAT 1 System (K240984)Abbott Point of Care, Inc.2025-01-03
Atellica® IM High-Sensitivity Troponin I (TnIH) (K241165)Siemens Healthcare Diagnostics, Inc.2024-07-25
PATHFAST®hs-cTnI-II (K231974)Phc Corporation2024-03-20
Access hsTnI (K222881)Beckman Coulter, Inc.2023-12-18
Access hsTnI (K230648)Beckman Coulter, Inc.2023-12-04
Alinity i STAT High Sensitivity Troponin-I (K230994)Abbott Laboratories Diagnostics Division2023-05-04
Alinity i STAT High Sensitivity Troponin-I (K202525)Abbott Laboratories Diagnostics Division2022-05-19
ARCHITECT STAT High Sensitivity Troponin-I (K191595)Abbott Laboratories Diagnostics Division2019-09-13

Recalls involving this device

No recalls on record reference this clearance.

PMA approvals by this applicant

RecordFirmDate
Elecsys Anti-HBs II, PreciControl Anti-HBs (P190034/S010)Roche Diagnostics2025-05-22
Elecsys Anti-HBe (P190005/S007)Roche Diagnostics2025-05-22
Elecsys Anti-HBe (P190005/S006)Roche Diagnostics2024-10-03
Elecsys Anti-HBs / Elecsys HBs II (P190034/S009)Roche Diagnostics2024-10-03
Elecsys Anti-HBs II (P190034/S008)Roche Diagnostics2024-08-29
Elecsys Anti-HBe (P190005/S005)Roche Diagnostics2024-08-29
Elecsys Anti-HBs II, PreciControl Anti-HBs (P190034/S007)Roche Diagnostics2024-07-23
Elecsys Anti-HBs II, PreciControl Anti-HBs (P190034/S005)Roche Diagnostics2024-05-01