Cleared Traditional

K012656 - LIQUICHEK CARDIAC MARKERS CONTROL LT LEVEL 1,2,3, MODELS 646,647,648 (FDA 510(k) Clearance)

Class I Chemistry device.

K012656 · Bio-Rad · Chemistry device
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Sep 2001
Decision
24d
Days
Class 1
Risk

K012656 is an FDA 510(k) clearance for the LIQUICHEK CARDIAC MARKERS CONTROL LT LEVEL 1,2,3, MODELS 646,647,648. Classified as Enzyme Controls (assayed And Unassayed) (product code JJT), Class I - General Controls.

Submitted by Bio-Rad (Irvine, US). The FDA issued a Cleared decision on September 6, 2001 after a review of 24 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.

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Submission Details

510(k) Number K012656 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 13, 2001
Decision Date September 06, 2001
Days to Decision 24 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
64d faster than avg
Panel avg: 88d · This submission: 24d
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.