Cleared Special

K070640 - ARCHITECT STAT TROPONIN-1

Also marketed or referenced as:
MYOGLOBIN

K070640 is the FDA 510(k) clearance for ARCHITECT STAT TROPONIN-1 by Fisher Diagnostics. It is a Class 2 Chemistry device (product code MMI) cleared through the Special 510(k) pathway after a 190-day FDA review.

K070640 · Fisher Diagnostics · Chemistry device
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Sep 2007
Decision
190d
Days
Class 2
Risk

K070640 is an FDA 510(k) clearance for the ARCHITECT STAT TROPONIN-1. Classified as Immunoassay Method, Troponin Subunit (product code MMI), Class II - Special Controls.

Submitted by Fisher Diagnostics (Middletown, US). The FDA issued a Cleared decision on September 13, 2007 after a review of 190 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. 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. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Fisher Diagnostics devices

Submission Details

510(k) Number K070640 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 07, 2007
Decision Date September 13, 2007
Days to Decision 190 days
Submission Type Special
Review Panel Chemistry (CH)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
102d slower than avg
Panel avg: 88d · This submission: 190d
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 69
Devices cleared under the same product code (MMI) and FDA review panel - the closest regulatory comparables to K070640.
ELECSYS TROPONIN I AND TROPONIN I STAT TEST SYSTEMS
K082699 · Roche Diagnostics · Aug 2009
DIMENSION TNI FLEX REAGENT CARTRIDGE, AND CTNI SAMPLE DILUENT WITH MODELS, RF621, KD692
K081643 · Siemens Healthcare Diagnostics · Jul 2008
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
VITROS TROPONIN I ES ASSAY, INCLUDING REAGENT PACK, CALIBRATORS AND RANGE VERIFIERS, MODELS 680 2301, 2302 AND 2303
K062838 · Ortho-Clinical Diagnostics · Dec 2006
ABBOTT AXSYM TROPONIN-I ADV
K060875 · Abbott Laboratories · Jun 2006