Cleared Traditional

K171274 - ADVIA Centaur High-Sensitivity Troponin...

K171274 is the FDA 510(k) clearance for ADVIA Centaur High-Sensitivity Troponin... by Siemens Healthcare Diagnostics, Inc.. It is a Class 2 Chemistry device (product code MMI) cleared through the Traditional 510(k) pathway after a 437-day FDA review.

K171274 · Siemens Healthcare Diagnostics, Inc. · Chemistry device
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Jul 2018
Decision
437d
Days
Class 2
Risk

K171274 is an FDA 510(k) clearance for the ADVIA Centaur High-Sensitivity Troponin I (TNIH). Classified as Immunoassay Method, Troponin Subunit (product code MMI), Class II - Special Controls.

Submitted by Siemens Healthcare Diagnostics, Inc. (Tarrytown, US). The FDA issued a Cleared decision on July 12, 2018 after a review of 437 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Chemistry submissions.

View all Siemens Healthcare Diagnostics, Inc. devices

Submission Details

510(k) Number K171274 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 01, 2017
Decision Date July 12, 2018
Days to Decision 437 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
349d slower than avg
Panel avg: 88d · This submission: 437d
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 68
Devices cleared under the same product code (MMI) and FDA review panel - the closest regulatory comparables to K171274.
Dimension EXL High-Sensitivity Troponin I (TNIH) Assay
K190675 · Siemens Healthcare Diagnostics, Inc. · May 2019
Dimension Vista High-Sensitivity Troponin I (TNIH) Assay
K182225 · Siemens Healthcare Diagnostics, Inc. · Mar 2019
Atellica IM High-Sensitivity Troponin I (TNIH)
K171566 · Siemens Healthcare Diagnostics, Inc. · Jul 2018
Access hsTnl
K172787 · Beckman Coulter, Inc. · Jun 2018
Access hs Tnl
K172783 · Beckman Coulter, Inc. · Jun 2018
Elecsys Troponin T Gen 5 STAT Assay, Elecsys Troponin T Gen 5 STAT CalSet, Elecsys PreciControl Troponin, Elecsys Troponin T Gen 5 CalCheck 5
K162895 · Roche Diagnostics · Jan 2017