Cleared Traditional

K840674 - SENSIBEAD EIA IGE KIT

K840674 is an FDA 510(k) clearance for SENSIBEAD EIA IGE KIT, manufactured by Terumo Medical Corp.. The device is a Class 2 Immunology device with product code DGC cleared through the Traditional 510(k) pathway after a 49-day FDA review.

K840674 · Terumo Medical Corp. · Immunology device
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Apr 1984
Decision
49d
Days
Class 2
Risk

K840674 is an FDA 510(k) clearance for the SENSIBEAD EIA IGE KIT. Classified as Ige, Antigen, Antiserum, Control (product code DGC), Class II - Special Controls.

Submitted by Terumo Medical Corp. (Elkton, US). The FDA issued a Cleared decision on April 4, 1984 after a review of 49 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 Terumo Medical Corp. devices

FDA 510(k) Submission Details - K840674

510(k) Number K840674 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 15, 1984
Decision Date April 04, 1984
Days to Decision 49 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
55d faster than avg
Panel avg: 104d · This submission: 49d
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 86
Devices cleared under the same product code (DGC) and FDA review panel - the closest regulatory comparables to K840674.
ALLERCOAT ALLERGEN DISCS
K842125 · Kallestad Laboratories, Inc. · Jun 1984
VAST VENTREX RAST ALL
K841651 · Ventrex Laboratories, Inc. · Jun 1984
PHADEXACT SERUM, TOTAL IGE CONTROLS
K840476 · Pharmacia, Inc. · May 1984
PHADEXACT SERUM, ALLERGEN SPECIFIC IGE
K840538 · Pharmacia, Inc. · Mar 1984
ABBOTT IGE EIA
K832360 · Abbott Laboratories · Oct 1983
ALLERGEN CONTROL INHALENT
K832218 · Ventrex Laboratories, Inc. · Sep 1983