Cleared Traditional

K182225 - Dimension Vista High-Sensitivity Troponin I (TNIH) Assay (FDA 510(k) Clearance)

Class II Chemistry device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K182225 · Siemens Healthcare Diagnostics, Inc. · Chemistry device
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Mar 2019
Decision
200d
Days
Class 2
Risk

K182225 is an FDA 510(k) clearance for the Dimension Vista High-Sensitivity Troponin I (TNIH) Assay. Classified as Immunoassay Method, Troponin Subunit (product code MMI), Class II - Special Controls.

Submitted by Siemens Healthcare Diagnostics, Inc. (Newark, US). The FDA issued a Cleared decision on March 4, 2019 after a review of 200 days - an extended review cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1215 - the FDA in vitro diagnostics and chemistry framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Chemistry review framework, consistent with the majority of Class II 510(k) submissions.

View all Siemens Healthcare Diagnostics, Inc. devices

Submission Details

510(k) Number K182225 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 16, 2018
Decision Date March 04, 2019
Days to Decision 200 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
112d slower than avg
Panel avg: 88d · This submission: 200d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code MMI Immunoassay Method, Troponin Subunit
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1215
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Chemistry devices follow this clearance model.

Regulatory Peers - MMI Immunoassay Method, Troponin Subunit

All 93
Devices cleared under the same product code (MMI) and FDA review panel - the closest regulatory comparables to K182225.
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i-STAT hs-TnI cartridge with the i-STAT 1 System
K240984 · Abbott Point of Care, Inc. · Jan 2025
Atellica® IM High-Sensitivity Troponin I (TnIH)
K241165 · Siemens Healthcare Diagnostics, Inc. · Jul 2024
PATHFAST®hs-cTnI-II
K231974 · Phc Corporation · Mar 2024