Cleared Traditional

K881899 - SPECIFIC ALLERGEN MODULES FOR ALASTAT(T...

K881899 is the FDA 510(k) clearance for SPECIFIC ALLERGEN MODULES FOR ALASTAT(T... by Diagnostic Products Corp.. It is a Class 2 Immunology device (product code DHB) cleared through the Traditional 510(k) pathway after a 96-day FDA review.

K881899 · Diagnostic Products Corp. · Immunology device
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Aug 1988
Decision
96d
Days
Class 2
Risk

K881899 is an FDA 510(k) clearance for the SPECIFIC ALLERGEN MODULES FOR ALASTAT(TM) IGE SYS.. 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 August 10, 1988 after a review of 96 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 K881899 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 06, 1988
Decision Date August 10, 1988
Days to Decision 96 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
8d faster than avg
Panel avg: 104d · This submission: 96d
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 K881899.
QUIDEL ALLERGY SCREEN
K883666 · Quidel Corp. · Oct 1988
SPECIFIC ALLERGEN MODULES FOR ALASTAT(TM)
K883616 · Diagnostic Products Corp. · Sep 1988
DHBTI-ALLERGEN IGE FASTSCREEN IV (G1,G5,G12,G13)
K883273 · 3M Company · Sep 1988
HOUSE DUST
K875110 · Incstar Corp. · Jun 1988
PHARMACIA IGG RAST RIA/PHARMACIA IGG RAST EIA
K880899 · Pharmacia, Inc. · May 1988
MARSH ELDER ALLERGEN DISC
K874540 · Incstar Corp. · May 1988