Cleared Traditional

K813189 - PHADEBAS/PHADEZYM IGE REAGENTS

K813189 is the FDA 510(k) clearance for PHADEBAS/PHADEZYM IGE REAGENTS by Pharmacia, Inc.. It is a Class 2 Immunology device (product code DGC) cleared through the Traditional 510(k) pathway after a 45-day FDA review.

K813189 · Pharmacia, Inc. · Immunology device
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Dec 1981
Decision
45d
Days
Class 2
Risk

K813189 is an FDA 510(k) clearance for the PHADEBAS/PHADEZYM IGE REAGENTS. 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 December 31, 1981 after a review of 45 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 K813189 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 16, 1981
Decision Date December 31, 1981
Days to Decision 45 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
59d faster than avg
Panel avg: 104d · This submission: 45d
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 K813189.
VAST VENTREX PD IGE RIA TEST SET
K821615 · Ventrex Laboratories, Inc. · Jun 1982
VENTRE/SPEC IGE CONTROLS
K820897 · Ventrex Laboratories, Inc. · May 1982
VENTREX 125I ANTI-IGE ALLERGY ISOTOPE
K820896 · Ventrex Laboratories, Inc. · Apr 1982
VENTRE/SEP IGE RIA TEST SET
K811559 · Ventrex Laboratories, Inc. · Jul 1981
KALLESTAD QUANTITOPE LOW LEVEL IGE REAG
K811545 · Kallestad Laboratories, Inc. · Jun 1981
TAN DEM* - IGE KIT
K802913 · Hybritech, Inc. · May 1981