Cleared Traditional

K912294 - ALLERGY INFORMATION MANAGER

K912294 is an FDA 510(k) clearance for ALLERGY INFORMATION MANAGER, manufactured by Diagnostic Products Corp.. The device is a Class 2 Immunology device with product code DHB cleared through the Traditional 510(k) pathway after a 186-day FDA review.

K912294 · Diagnostic Products Corp. · Immunology device
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Nov 1991
Decision
186d
Days
Class 2
Risk

K912294 is an FDA 510(k) clearance for the ALLERGY INFORMATION MANAGER. Classified as System, Test, Radioallergosorbent (rast) Immunological (product code DHB), Class II - Special Controls.

Submitted by Diagnostic Products Corp. (Los Angeles, US). The FDA issued a Cleared decision on November 22, 1991 after a review of 186 days - an extended review 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: 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.

FDA 510(k) Submission Details - K912294

510(k) Number K912294 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 20, 1991
Decision Date November 22, 1991
Days to Decision 186 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
81d slower than avg
Panel avg: 105d · This submission: 186d
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 264
Devices cleared under the same product code (DHB) and FDA review panel - the closest regulatory comparables to K912294.
VENTREX ALLERGEN DISC
K913833 · Ventrex Laboratories, Inc. · Feb 1992
CHEMILUMINESCENT SYSTEM ALLERGAN SPECIFIC IGE
K914850 · Mast Immunosystems · Dec 1991
ABBOTT MATRIX AERO PLUS SYSTEM
K913150 · Abbott Laboratories · Nov 1991
3M IGE SINGLE POINT FAST TEST
K913212 · Whittaker Bioproducts, Inc. · Nov 1991
FASTTECH SYSTEM II
K913892 · 3M Diagnostic Systems, Inc. · Oct 1991
ALLERGANS PHARMACIA CAP SYS.RAST RIA/FEIA
K911903 · Pharmacia, Inc. · Aug 1991
K912294 · ALLERGY INFORMATION MANAGER
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