Cleared Special

K070640 - ARCHITECT STAT TROPONIN-1 (FDA 510(k) Clearance)

Also includes:
MYOGLOBIN

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

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 93
Devices cleared under the same product code (MMI) and FDA review panel - the closest regulatory comparables to K070640.
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K241165 · Siemens Healthcare Diagnostics, Inc. · Jul 2024
PATHFAST®hs-cTnI-II
K231974 · Phc Corporation · Mar 2024