Cleared Traditional

K851512 - ALLERGENETICS IGE FAST TEST

K851512 is the FDA 510(k) clearance for ALLERGENETICS IGE FAST TEST by Allergenetics. It is a Class 2 Immunology device (product code DHB) cleared through the Traditional 510(k) pathway after a 43-day FDA review.

K851512 · Allergenetics · Immunology device
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May 1985
Decision
43d
Days
Class 2
Risk

K851512 is an FDA 510(k) clearance for the ALLERGENETICS IGE FAST TEST. Classified as System, Test, Radioallergosorbent (rast) Immunological (product code DHB), Class II - Special Controls.

Submitted by Allergenetics (Mountain View, US). The FDA issued a Cleared decision on May 28, 1985 after a review of 43 days - a notably fast clearance cycle.

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: 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 Allergenetics devices

Submission Details

510(k) Number K851512 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 15, 1985
Decision Date May 28, 1985
Days to Decision 43 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
61d faster than avg
Panel avg: 104d · This submission: 43d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 201
Devices cleared under the same product code (DHB) and FDA review panel - the closest regulatory comparables to K851512.
PHADEBAS RAST/PHADEZYM RAST ALLERTUBES
K853456 · Pharmacia, Inc. · Sep 1985
PHADEBAS RAST TEST ALLERGEN DISCS
K852189 · Pharmacia, Inc. · Jul 1985
PHADEBAS RAST/PHADEZYM RAST ALLERTUBES
K852263 · Pharmacia, Inc. · Jun 1985
PHADEBAS RAST PHADEZYM RAST ALLERTUBES
K851273 · Pharmacia, Inc. · May 1985
PHADEBAS RAST/PHADEZYM RAST ALLERGEN DISCS
K845032 · Pharmacia, Inc. · Mar 1985
PHADEXACT SERUM, ALLERGEN SPECIFIC IGE
K842457 · Pharmacia, Inc. · Jul 1984