Cleared Traditional

K853025 - IMAGE-IGE

K853025 is the FDA 510(k) clearance for IMAGE-IGE by Clinical Reference Laboratory, Inc.. It is a Class 2 Immunology device (product code DGC) cleared through the Traditional 510(k) pathway after a 35-day FDA review.

K853025 · Clinical Reference Laboratory, Inc. · Immunology device
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Aug 1985
Decision
35d
Days
Class 2
Risk

K853025 is an FDA 510(k) clearance for the IMAGE-IGE. Classified as Ige, Antigen, Antiserum, Control (product code DGC), Class II - Special Controls.

Submitted by Clinical Reference Laboratory, Inc. (Lenexa, US). The FDA issued a Cleared decision on August 22, 1985 after a review of 35 days - a notably fast clearance cycle.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 866.5510 - the FDA immunology device 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 Clinical Reference Laboratory, Inc. devices

Submission Details

510(k) Number K853025 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 18, 1985
Decision Date August 22, 1985
Days to Decision 35 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
69d faster than avg
Panel avg: 104d · This submission: 35d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DGC Ige, Antigen, Antiserum, Control
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.5510
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Immunology devices follow this clearance model.

Regulatory Peers - DGC Ige, Antigen, Antiserum, Control

All 84
Devices cleared under the same product code (DGC) and FDA review panel - the closest regulatory comparables to K853025.
TOTAL IGE-IRMA RIA KIT
K860032 · Diagnostic Products Corp. · Apr 1986
EIA MONOCLONAL TOTAL IGE KIT
K860033 · Diagnostic Products Corp. · Apr 1986
THE DPC MONOCLONAL EIA TOTAL IGE KIT
K852878 · Diagnostic Products Corp. · Aug 1985
QUANTICLONE IGE RADIOIMMUNASSAY
K852268 · Kallestad Laboratories, Inc. · Jul 1985
PHARMACIA IGE RIA MODIFIED
K851156 · Pharmacia, Inc. · Apr 1985
ENCORE IGE REAGENT
K843408 · Hybritech, Inc. · Oct 1984