Cleared Traditional

K860645 - ELECTROPHORESIS DATA CENTER (EDC)

K860645 is the FDA 510(k) clearance for ELECTROPHORESIS DATA CENTER (EDC) by Helena Laboratories. It is a Class 1 Chemistry device (product code JQT) cleared through the Traditional 510(k) pathway after a 300-day FDA review.

K860645 · Helena Laboratories · Chemistry device
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Dec 1986
Decision
300d
Days
Class 1
Risk

K860645 is an FDA 510(k) clearance for the ELECTROPHORESIS DATA CENTER (EDC). Classified as Densitometer/scanner (integrating, Reflectance, Tlc, Radiochromat.) Clinica (product code JQT), Class I - General Controls.

Submitted by Helena Laboratories (Beaumont, US). The FDA issued a Cleared decision on December 17, 1986 after a review of 300 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.2400 - 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Chemistry review framework, consistent with the majority of Class II 510(k) submissions.

View all Helena Laboratories devices

Submission Details

510(k) Number K860645 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 20, 1986
Decision Date December 17, 1986
Days to Decision 300 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
212d slower than avg
Panel avg: 88d · This submission: 300d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code JQT Densitometer/scanner (integrating, Reflectance, Tlc, Radiochromat.) Clinica
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.2400
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 - JQT Densitometer/scanner (integrating, Reflectance, Tlc, Radiochromat.) Clinica

All 7
Devices cleared under the same product code (JQT) and FDA review panel - the closest regulatory comparables to K860645.
ISOSCAN
K944185 · Isolab, Inc. · Nov 1994
MODEL 795 FLUOROMETER/DENSITOMETER
K915332 · Ciba Corning Diagnostics Corp. · Feb 1992
ICON READER
K862956 · Hybritech, Inc. · Aug 1986
CORNING 780 FLUOROMETER/DENSITOMETER
K850617 · Corning Medical & Scientific · Mar 1985
710 FLUOROMETER/DENSITOMETER
K810619 · Corning Medical & Scientific · Mar 1981
AUTOMATED ELECTROPHORESIS SYSTEM
K780901 · Olympus Corp. · Jun 1978