Cleared Traditional

K780464 - LELECTIVE KINETIC SYSTEM-60

K780464 is the FDA 510(k) clearance for LELECTIVE KINETIC SYSTEM-60 by Hycel, Inc.. It is a Class 1 Chemistry device (product code JJE) cleared through the Traditional 510(k) pathway after a 42-day FDA review.

K780464 · Hycel, Inc. · Chemistry device
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May 1978
Decision
42d
Days
Class 1
Risk

K780464 is an FDA 510(k) clearance for the LELECTIVE KINETIC SYSTEM-60. Classified as Analyzer, Chemistry (photometric, Discrete), For Clinical Use (product code JJE), Class I - General Controls.

Submitted by Hycel, Inc. (Mchenry, US). The FDA issued a Cleared decision on May 3, 1978 after a review of 42 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.2160 - 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 Hycel, Inc. devices

Submission Details

510(k) Number K780464 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 22, 1978
Decision Date May 03, 1978
Days to Decision 42 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
46d faster than avg
Panel avg: 88d · This submission: 42d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code JJE Analyzer, Chemistry (photometric, Discrete), For Clinical Use
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.2160
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 - JJE Analyzer, Chemistry (photometric, Discrete), For Clinical Use

All 144
Devices cleared under the same product code (JJE) and FDA review panel - the closest regulatory comparables to K780464.
PRISMA
K791297 · Lkb Instruments, Inc. · Aug 1979
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K782014 · Abbott Laboratories · Jan 1979
COULTER ELECTROLYTE ANALYZER SYSTEM
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ANALYZER, 100, BICHROMATIC, ABBOTT
K780388 · Syva Co. · Mar 1978
MODEL 2/2 ANALYZER
K771245 · Eastman Kodak Company · Oct 1977
BICHROMATIC ANALYZER ABA-200
K771345 · Abbott Laboratories · Aug 1977