Cleared Special

DIMENSION TNI FLEX REAGENT CARTRIDGE, AND CTNI SAMPLE DILUENT WITH MODELS, RF621, KD692 (K081643) - FDA 510(k) Clearance

Class II Chemistry device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K081643 · Siemens Healthcare Diagnostics · Chemistry device
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Optimized for regulatory review, auditing and printing
Jul 2008
Decision
21d
Days
Class 2
Risk

K081643 is an FDA 510(k) clearance for the DIMENSION TNI FLEX REAGENT CARTRIDGE, AND CTNI SAMPLE DILUENT WITH MODELS, RF.... Classified as Immunoassay Method, Troponin Subunit (product code MMI), Class II - Special Controls.

Submitted by Siemens Healthcare Diagnostics (Newark, US). The FDA issued a Cleared decision on July 3, 2008 after a review of 21 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1215 - the FDA in vitro diagnostics and chemistry framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Siemens Healthcare Diagnostics devices

Submission Details

510(k) Number K081643 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 12, 2008
Decision Date July 03, 2008
Days to Decision 21 days
Submission Type Special
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
67d faster than avg
Panel avg: 88d · This submission: 21d
Pathway characteristics
Modification to existing cleared device.

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 51
Devices cleared under the same product code (MMI) and FDA review panel - the closest regulatory comparables to K081643.
ACCESS ACCUTNI REAGENT, ACCESS ACCUTNI CALIBRATOR, UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM
K121790 · Beckman Coulter, Inc. · Sep 2013
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K121214 · Beckman Coulter, Inc. · Jun 2013
ELECSYS TROPONIN I AND TROPONIN I STAT TEST SYSTEMS
K082699 · Roche Diagnostics · Aug 2009
VIDAS TROPONIN I ULTRA (TNIU) ASSAY, MODEL 30 448
K063243 · bioMerieux, Inc. · Dec 2007
DIMENSION VISTA CTNI FLEX REAGENT CARTRIDGE
K063756 · Dade Behring, Inc. · Mar 2007
ABBOTT AXSYM TROPONIN-I ADV
K060875 · Abbott Laboratories · Jun 2006