Cleared Traditional

K855006 - CANTROL CK/MB CONTROL

K855006 is an FDA 510(k) clearance for CANTROL CK/MB CONTROL, manufactured by Canyon Diagnostics, Inc.. The device is a Class 1 Chemistry device with product code JJT cleared through the Traditional 510(k) pathway after a 35-day FDA review.

K855006 · Canyon Diagnostics, Inc. · Chemistry device
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Jan 1986
Decision
35d
Days
Class 1
Risk

K855006 is an FDA 510(k) clearance for the CANTROL CK/MB CONTROL. Classified as Enzyme Controls (assayed And Unassayed) (product code JJT), Class I - General Controls.

Submitted by Canyon Diagnostics, Inc. (Anaheim, US). The FDA issued a Cleared decision on January 17, 1986 after a review of 35 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 Canyon Diagnostics, Inc. devices

FDA 510(k) Submission Details - K855006

510(k) Number K855006 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 13, 1985
Decision Date January 17, 1986
Days to Decision 35 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
53d faster than avg
Panel avg: 88d · This submission: 35d
Pathway characteristics
Predicate-based equivalence.

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 81
Devices cleared under the same product code (JJT) and FDA review panel - the closest regulatory comparables to K855006.
EMDS, CK/CK-MB VERIFIER, ITEM NUMBER 67---/95
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ISOTRAK AMYLASE ISOENZYME CONTROL SET
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V-TREND OC CPK
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DELTA TROL I & II
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CK/LD ISOENZYMES CONTROLS(HUMAN)
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