Cleared Traditional

K843408 - ENCORE IGE REAGENT

K843408 is the FDA 510(k) clearance for ENCORE IGE REAGENT by Hybritech, Inc.. It is a Class 2 Immunology device (product code DGC) cleared through the Traditional 510(k) pathway after a 31-day FDA review.

K843408 · Hybritech, Inc. · Immunology device
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Oct 1984
Decision
31d
Days
Class 2
Risk

K843408 is an FDA 510(k) clearance for the ENCORE IGE REAGENT. Classified as Ige, Antigen, Antiserum, Control (product code DGC), Class II - Special Controls.

Submitted by Hybritech, Inc. (Mchenry, US). The FDA issued a Cleared decision on October 1, 1984 after a review of 31 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 Hybritech, Inc. devices

Submission Details

510(k) Number K843408 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 31, 1984
Decision Date October 01, 1984
Days to Decision 31 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
73d faster than avg
Panel avg: 104d · This submission: 31d
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 83
Devices cleared under the same product code (DGC) and FDA review panel - the closest regulatory comparables to K843408.
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
PHARMACIA IGE RIA
K841824 · Pharmacia, Inc. · Jun 1984
PHADEBAS RAST PHADEZYM RAST ALLERGEN
K841829 · Pharmacia, Inc. · Jun 1984
ALLERCOAT ALLERGEN DISCS
K842125 · Kallestad Laboratories, Inc. · Jun 1984