Cleared Traditional

K840476 - PHADEXACT SERUM, TOTAL IGE CONTROLS

K840476 is an FDA 510(k) clearance for PHADEXACT SERUM, manufactured by Pharmacia, Inc.. The device is a Class 2 Chemistry device with product code DGC cleared through the Traditional 510(k) pathway after a 108-day FDA review.

K840476 · Pharmacia, Inc. · Chemistry device
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May 1984
Decision
108d
Days
Class 2
Risk

K840476 is an FDA 510(k) clearance for the PHADEXACT SERUM, TOTAL IGE CONTROLS. Classified as Ige, Antigen, Antiserum, Control (product code DGC), Class II - Special Controls.

Submitted by Pharmacia, Inc. (Mchenry, US). The FDA issued a Cleared decision on May 21, 1984 after a review of 108 days - within the typical 510(k) review window.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 866.5510 - the FDA in vitro diagnostics and chemistry framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Chemistry review framework, consistent with the majority of Class II 510(k) submissions.

View all Pharmacia, Inc. devices

FDA 510(k) Submission Details - K840476

510(k) Number K840476 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 03, 1984
Decision Date May 21, 1984
Days to Decision 108 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
20d slower than avg
Panel avg: 88d · This submission: 108d
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 Chemistry devices follow this clearance model.

Regulatory Peers - DGC Ige, Antigen, Antiserum, Control

All 90
Devices cleared under the same product code (DGC) and FDA review panel - the closest regulatory comparables to K840476.
PHADEBAS RAST PHADEZYM RAST ALLERGEN
K841829 · Pharmacia, Inc. · Jun 1984
ALLERCOAT ALLERGEN DISCS
K842125 · Kallestad Laboratories, Inc. · Jun 1984
VAST VENTREX RAST ALL
K841651 · Ventrex Laboratories, Inc. · Jun 1984
SENSIBEAD EIA IGE KIT
K840674 · Terumo Medical Corp. · Apr 1984
PHADEXACT SERUM, ALLERGEN SPECIFIC IGE
K840538 · Pharmacia, Inc. · Mar 1984
ABBOTT IGE EIA
K832360 · Abbott Laboratories · Oct 1983