Cleared Traditional

K881899 - SPECIFIC ALLERGEN MODULES FOR ALASTAT(TM) IGE SYS.

K881899 is an FDA 510(k) clearance for SPECIFIC ALLERGEN MODULES FOR ALASTAT(T..., 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 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

FDA 510(k) Submission Details - K881899

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
9d faster than avg
Panel avg: 105d · This submission: 96d
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 230
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