Cleared Traditional

ABBOTT IGE EIA (K832360) - FDA 510(k) Clearance

Class II Chemistry device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K832360 · Abbott Laboratories · Chemistry device
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Oct 1983
Decision
88d
Days
Class 2
Risk

K832360 is an FDA 510(k) clearance for the ABBOTT IGE EIA. Classified as Ige, Antigen, Antiserum, Control (product code DGC), Class II - Special Controls.

Submitted by Abbott Laboratories (Abbott Park, US). The FDA issued a Cleared decision on October 14, 1983 after a review of 88 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 866.5510 - 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 Abbott Laboratories devices

Submission Details

510(k) Number K832360 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 18, 1983
Decision Date October 14, 1983
Days to Decision 88 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
At panel average
Panel avg: 88d · This submission: 88d
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 Chemistry devices follow this clearance model.

Regulatory Peers - DGC Ige, Antigen, Antiserum, Control

All 42
Devices cleared under the same product code (DGC) and FDA review panel - the closest regulatory comparables to K832360.
PHADEXACT SERUM, TOTAL IGE CONTROLS
K840476 · Pharmacia, Inc. · May 1984
SENSIBEAD EIA IGE KIT
K840674 · Terumo Medical Corp. · Apr 1984
PHADEXACT SERUM, ALLERGEN SPECIFIC IGE
K840538 · Pharmacia, Inc. · Mar 1984
PHADEBAS RAST ALLERGEN DISCS
K823841 · Pharmacia, Inc. · Jan 1983
PHADEZYM RAST ALLERGEN DISCS
K823842 · Pharmacia, Inc. · Jan 1983
PHADEBAS/PHADEZYM IGE REAGENTS
K813189 · Pharmacia, Inc. · Dec 1981