Cleared Special

K062751 - MODIFICATION TO QUANTIMETRIX CARDIASURE CARDIAC MARKER

K062751 is an FDA 510(k) clearance for MODIFICATION TO QUANTIMETRIX CARDIASURE..., manufactured by Quantimetrix Corp.. The device is a Class 1 Chemistry device with product code JJT cleared through the Special 510(k) pathway after a 19-day FDA review.

K062751 · Quantimetrix Corp. · Chemistry device
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Oct 2006
Decision
19d
Days
Class 1
Risk

K062751 is an FDA 510(k) clearance for the MODIFICATION TO QUANTIMETRIX CARDIASURE CARDIAC MARKER. Classified as Enzyme Controls (assayed And Unassayed) (product code JJT), Class I - General Controls.

Submitted by Quantimetrix Corp. (Redondo Beach, US). The FDA issued a Cleared decision on October 3, 2006 after a review of 19 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1660 - 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.

FDA 510(k) Submission Details - K062751

510(k) Number K062751 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 14, 2006
Decision Date October 03, 2006
Days to Decision 19 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
69d faster than avg
Panel avg: 88d · This submission: 19d
Pathway characteristics
Modification to existing cleared device.

JJT Device Classification - Class 1, General Controls

Product Code JJT Enzyme Controls (assayed And Unassayed)
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.1660
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - JJT Enzyme Controls (assayed And Unassayed)

All 86
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K021498 · Bio-Rad · May 2002
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K012656 · Bio-Rad · Sep 2001
CARDIASURE CARDIAC MARKERS CONTROL
K993723 · Quantimetrix Corp. · Nov 1999
K062751 · MODIFICATION TO QUANTIMETRIX CARDIASURE CARDIAC MARKER
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