Cleared Traditional

AGGLUTINATION TEST FOR TOTAL IGE (K843369) - FDA 510(k) Clearance

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

K843369 · Scientific Research · Immunology device
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Nov 1984
Decision
78d
Days
Class 2
Risk

K843369 is an FDA 510(k) clearance for the AGGLUTINATION TEST FOR TOTAL IGE. Classified as Ige, Antigen, Antiserum, Control (product code DGC), Class II - Special Controls.

Submitted by Scientific Research (Abilene, US). The FDA issued a Cleared decision on November 14, 1984 after a review of 78 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 Scientific Research devices

Submission Details

510(k) Number K843369 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 28, 1984
Decision Date November 14, 1984
Days to Decision 78 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
26d faster than avg
Panel avg: 104d · This submission: 78d
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 42
Devices cleared under the same product code (DGC) and FDA review panel - the closest regulatory comparables to K843369.
EIA MONOCLONAL TOTAL IGE KIT
K860033 · Diagnostic Products Corp. · Apr 1986
THE DPC MONOCLONAL EIA TOTAL IGE KIT
K852878 · Diagnostic Products Corp. · Aug 1985
PHARMACIA IGE RIA MODIFIED
K851156 · Pharmacia, Inc. · Apr 1985
PHARMACIA IGE RIA
K841824 · Pharmacia, Inc. · Jun 1984
PHADEBAS RAST PHADEZYM RAST ALLERGEN
K841829 · Pharmacia, Inc. · Jun 1984
PHADEXACT SERUM, TOTAL IGE CONTROLS
K840476 · Pharmacia, Inc. · May 1984