Cleared Traditional

K993723 - CARDIASURE CARDIAC MARKERS CONTROL

K993723 is the FDA 510(k) clearance for CARDIASURE CARDIAC MARKERS CONTROL by Quantimetrix Corp.. It is a Class 1 Chemistry device (product code JJT) cleared through the Traditional 510(k) pathway after a 20-day FDA review.

K993723 · Quantimetrix Corp. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 1999
Decision
20d
Days
Class 1
Risk

K993723 is an FDA 510(k) clearance for the CARDIASURE CARDIAC MARKERS CONTROL. 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 November 23, 1999 after a review of 20 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Quantimetrix Corp. devices

Submission Details

510(k) Number K993723 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 03, 1999
Decision Date November 23, 1999
Days to Decision 20 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
68d faster than avg
Panel avg: 88d · This submission: 20d
Pathway characteristics
Predicate-based equivalence.

Device Classification

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 40
Devices cleared under the same product code (JJT) and FDA review panel - the closest regulatory comparables to K993723.
LIQUICHEK CARDIAC MARKERS CONTROL LT LEVEL 1, 2, 3, AND TRILEVEL
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K012656 · Bio-Rad · Sep 2001
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K984437 · Instrumentation Laboratory CO · Feb 1999
CARDIOIMMUNE CARDIAC MARKER CONTROL LEVELS 1,2, AND 3
K984277 · Medical Analysis Systems, Inc. · Dec 1998
LIQUICHEK CARDIAC MARKERS CONTROL LT
K980556 · Bio-Rad · Feb 1998