Cleared Special

K070640 - ARCHITECT STAT TROPONIN-1

Also marketed or referenced as:
MYOGLOBIN

K070640 is an FDA 510(k) clearance for ARCHITECT STAT TROPONIN-1, manufactured by Fisher Diagnostics. The device is a Class 2 Chemistry device with 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.

FDA 510(k) Submission Details - K070640

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
101d slower than avg
Panel avg: 89d · This submission: 190d
Pathway characteristics
Modification to existing cleared device.

MMI Device Classification - Class 2, Special Controls

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 94
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
K070640 · ARCHITECT STAT TROPONIN-1
Download PDF Fisher Diagnostics