Cleared Traditional

K843369 - AGGLUTINATION TEST FOR TOTAL IGE

K843369 is an FDA 510(k) clearance for AGGLUTINATION TEST FOR TOTAL IGE, manufactured by Scientific Research. The device is a Class 2 Immunology device with product code DGC cleared through the Traditional 510(k) pathway after a 78-day FDA review.

K843369 · Scientific Research · Immunology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

FDA 510(k) Submission Details - K843369

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
27d faster than avg
Panel avg: 105d · This submission: 78d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DGC Device Classification - Class 2, Special Controls

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 91
Devices cleared under the same product code (DGC) and FDA review panel - the closest regulatory comparables to K843369.
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
PHARMACIA IGE RIA
K841824 · Pharmacia, Inc. · Jun 1984
PHADEBAS RAST PHADEZYM RAST ALLERGEN
K841829 · Pharmacia, Inc. · Jun 1984