Cleared Traditional

K854865 - PHADEBAS RAST PHADEZYM RAST DISCS FX2,FX3 & FX5

K854865 is an FDA 510(k) clearance for PHADEBAS RAST PHADEZYM RAST DISCS FX2, manufactured by Pharmacia, Inc.. The device is a Class 2 Immunology device with product code DHB cleared through the Traditional 510(k) pathway after a 144-day FDA review.

K854865 · Pharmacia, Inc. · Immunology device
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Apr 1986
Decision
144d
Days
Class 2
Risk

K854865 is an FDA 510(k) clearance for the PHADEBAS RAST PHADEZYM RAST DISCS FX2,FX3 & FX5. Classified as System, Test, Radioallergosorbent (rast) Immunological (product code DHB), Class II - Special Controls.

Submitted by Pharmacia, Inc. (Piscataway, US). The FDA issued a Cleared decision on April 22, 1986 after a review of 144 days - within the typical 510(k) review window.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 866.5750 - 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Immunology review framework, consistent with the majority of Class II 510(k) submissions.

View all Pharmacia, Inc. devices

FDA 510(k) Submission Details - K854865

510(k) Number K854865 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 29, 1985
Decision Date April 22, 1986
Days to Decision 144 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
39d slower than avg
Panel avg: 105d · This submission: 144d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DHB Device Classification - Class 2, Special Controls

Product Code DHB System, Test, Radioallergosorbent (rast) Immunological
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.5750
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 - DHB System, Test, Radioallergosorbent (rast) Immunological

All 231
Devices cleared under the same product code (DHB) and FDA review panel - the closest regulatory comparables to K854865.
WHITE OAK ALLERGEN DISC
K862175 · Immuno Nuclear Corp. · Jun 1986
SHORT RAGWEED ALLERGEN DISC
K854756 · Immuno Nuclear Corp. · May 1986
PHADEBAS RAST/PHADEZYM RAST TEST ALLERGEN DISCS
K861184 · Pharmacia, Inc. · Apr 1986
PHADEBAS RAST/PHADEZYM RAST ALLERTUBES
K854939 · Pharmacia, Inc. · Feb 1986
PHADEBAS RAST TEST ALLERGEN DISCS
K853969 · Pharmacia, Inc. · Nov 1985
VENTREZYME, VAST IMMUNOPEROXIDASE ASSAY
K850895 · Ventrex Laboratories, Inc. · Oct 1985