Cleared Traditional

K840538 - PHADEXACT SERUM

K840538 is the FDA 510(k) clearance for PHADEXACT SERUM by Pharmacia, Inc.. It is a Class 2 Immunology device (product code DGC) cleared through the Traditional 510(k) pathway after a 44-day FDA review.

K840538 · Pharmacia, Inc. · Immunology device
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Mar 1984
Decision
44d
Days
Class 2
Risk

K840538 is an FDA 510(k) clearance for the PHADEXACT SERUM, ALLERGEN SPECIFIC IGE. Classified as Ige, Antigen, Antiserum, Control (product code DGC), Class II - Special Controls.

Submitted by Pharmacia, Inc. (Walker, US). The FDA issued a Cleared decision on March 23, 1984 after a review of 44 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 Pharmacia, Inc. devices

Submission Details

510(k) Number K840538 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 08, 1984
Decision Date March 23, 1984
Days to Decision 44 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
60d faster than avg
Panel avg: 104d · This submission: 44d
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 81
Devices cleared under the same product code (DGC) and FDA review panel - the closest regulatory comparables to K840538.
VAST VENTREX RAST ALL
K841651 · Ventrex Laboratories, Inc. · Jun 1984
PHADEXACT SERUM, TOTAL IGE CONTROLS
K840476 · Pharmacia, Inc. · May 1984
SENSIBEAD EIA IGE KIT
K840674 · Terumo Medical Corp. · Apr 1984
ABBOTT IGE EIA
K832360 · Abbott Laboratories · Oct 1983
ALLERGEN CONTROL INHALENT
K832218 · Ventrex Laboratories, Inc. · Sep 1983
ALLERCOAT ALLERGEN DISCS
K831326 · Kallestad Laboratories, Inc. · Jun 1983