Cleared Traditional

K954566 - SPECIFIC ALLERGEN MODULES FOR THE ALAST...

K954566 is the FDA 510(k) clearance for SPECIFIC ALLERGEN MODULES FOR THE ALAST... by Diagnostic Products Corp.. It is a Class 2 Immunology device (product code DHB) cleared through the Traditional 510(k) pathway after a 77-day FDA review.

K954566 · Diagnostic Products Corp. · Immunology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 1995
Decision
77d
Days
Class 2
Risk

K954566 is an FDA 510(k) clearance for the SPECIFIC ALLERGEN MODULES FOR THE ALASTAT MICROPLATE ALLERGEN-SPECIFIC IGE SY.... 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 18, 1995 after a review of 77 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Diagnostic Products Corp. devices

Submission Details

510(k) Number K954566 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 02, 1995
Decision Date December 18, 1995
Days to Decision 77 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
27d faster than avg
Panel avg: 104d · This submission: 77d
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 K954566.
SPECIFIC ALLERGEN MODULES AND MIXED ALLERGEN PANELS FOR ALASTAT MICROPLATE AND ALASTAT EIA ALLERGEN-SPECIFIC IGE SYSTEMS
K961889 · Diagnostic Products Corp. · Oct 1996
UNICAP 100
K962274 · Pharmacia, Inc. · Sep 1996
PHARMACIA CAP SYSTEM PHADIATOP FEIA
K941993 · Pharmacia, Inc. · Jan 1996
ACCESS ALLERGEN DOG EPITHELIM
K953780 · Bio-Rad Laboratories, Inc. · Nov 1995
QUICKVUE ONE-STEP ALLERGEN SCREEN
K950728 · Quidel Corp. · Oct 1995
ALASTAT MICROPLATE LATEX-SPECIFIC IGE ALLERGEN
K953014 · Diagnostic Products Corp. · Aug 1995