Cleared Traditional

K941564 - IMMULITE ALATOP ALLERGY SCREEN

K941564 is an FDA 510(k) clearance for IMMULITE ALATOP ALLERGY SCREEN, 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 262-day FDA review.

K941564 · Diagnostic Products Corp. · Immunology device
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Dec 1994
Decision
262d
Days
Class 2
Risk

K941564 is an FDA 510(k) clearance for the IMMULITE ALATOP ALLERGY SCREEN. 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 December 19, 1994 after a review of 262 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.

View all Diagnostic Products Corp. devices

FDA 510(k) Submission Details - K941564

510(k) Number K941564 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 01, 1994
Decision Date December 19, 1994
Days to Decision 262 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
157d slower than avg
Panel avg: 105d · This submission: 262d
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 K941564.
HY-TEC AUTOMATED EIA SYSTEM
K941278 · Hycor Biomedical, Inc. · Mar 1995
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K943768 · Diagnostic Products Corp. · Mar 1995
SPECIFIC IGE EIA-ULTRA ASSAY
K941057 · Hycor Biomedical, Inc. · Jan 1995
ALATOP(R) MICROPLATE ALLERGY SCREEN
K935488 · Diagnostic Products Corp. · Mar 1994
ACCESS SPECIFIC IGE ASSAY
K935876 · Bio-Rad Laboratories, Inc. · Mar 1994
CIBA CORNING MAGIC LITE SQ SPECIFIC IGE ASSAY
K923420 · Ciba Corning Diagnostics Corp. · Feb 1993