Cleared Traditional

K875244 - ALLEIA (TM) ALLERGEN SPECIFIC IGE SYSTEM

K875244 is the FDA 510(k) clearance for ALLEIA (TM) ALLERGEN SPECIFIC IGE SYSTEM by Diagnostic Products Corp.. It is a Class 2 Immunology device (product code DHB) cleared through the Traditional 510(k) pathway after a 121-day FDA review.

K875244 · Diagnostic Products Corp. · Immunology device
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Apr 1988
Decision
121d
Days
Class 2
Risk

K875244 is an FDA 510(k) clearance for the ALLEIA (TM) ALLERGEN SPECIFIC IGE SYSTEM. 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 April 21, 1988 after a review of 121 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 Diagnostic Products Corp. devices

Submission Details

510(k) Number K875244 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 22, 1987
Decision Date April 21, 1988
Days to Decision 121 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
17d slower than avg
Panel avg: 104d · This submission: 121d
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 186
Devices cleared under the same product code (DHB) and FDA review panel - the closest regulatory comparables to K875244.
INCSTAR'S BIRCH ALLERGEN DISC
K880168 · Incstar Corp. · May 1988
INCSTAR'S PIGWEED ALLERGEN DISC
K880221 · Incstar Corp. · May 1988
GOLDENROD ALLERGEN DISC
K875163 · Incstar Corp. · Apr 1988
DPC'S ALLERGEN-SPECIFIC IGE SYSTEM
K880160 · Diagnostic Products Corp. · Apr 1988
INCSTAR'S DANDELION ALLERGEN DISC
K880187 · Incstar Corp. · Apr 1988
MESQUITE ALLERGEN DISC
K880415 · Incstar Corp. · Apr 1988