Cleared Traditional

K862956 - ICON READER

K862956 is an FDA 510(k) clearance for ICON READER, manufactured by Hybritech, Inc.. The device is a Class 1 Chemistry device with product code JQT cleared through the Traditional 510(k) pathway after a 14-day FDA review.

K862956 · Hybritech, Inc. · Chemistry device
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Aug 1986
Decision
14d
Days
Class 1
Risk

K862956 is an FDA 510(k) clearance for the ICON READER. Classified as Densitometer/scanner (integrating, Reflectance, Tlc, Radiochromat.) Clinica (product code JQT), Class I - General Controls.

Submitted by Hybritech, Inc. (San Diego, US). The FDA issued a Cleared decision on August 19, 1986 after a review of 14 days - a notably fast clearance cycle.

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: 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 Hybritech, Inc. devices

FDA 510(k) Submission Details - K862956

510(k) Number K862956 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 05, 1986
Decision Date August 19, 1986
Days to Decision 14 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
74d faster than avg
Panel avg: 88d · This submission: 14d
Pathway characteristics
Predicate-based equivalence.

JQT Device Classification - Class 1, General Controls

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 12
Devices cleared under the same product code (JQT) and FDA review panel - the closest regulatory comparables to K862956.
MODEL 795 FLUOROMETER/DENSITOMETER
K915332 · Ciba Corning Diagnostics Corp. · Feb 1992
TARGET READER
K885254 · V-Tech, Inc. · Jan 1989
ELECTROPHORESIS DATA CENTER (EDC)
K860645 · Helena Laboratories · Dec 1986
CORNING 780 FLUOROMETER/DENSITOMETER
K850617 · Corning Medical & Scientific · Mar 1985
GLEMAN ACD-2020 AUTOMATIC COMPUTING DENSITOMETER
K850260 · Gelman Sciences, Inc. · Feb 1985
710 FLUOROMETER/DENSITOMETER
K810619 · Corning Medical & Scientific · Mar 1981