Cleared Traditional

K953014 - ALASTAT MICROPLATE LATEX-SPECIFIC IGE A...

K953014 is the FDA 510(k) clearance for ALASTAT MICROPLATE LATEX-SPECIFIC IGE A... by Diagnostic Products Corp.. It is a Class 2 Immunology device (product code DHB) cleared through the Traditional 510(k) pathway after a 47-day FDA review.

K953014 · Diagnostic Products Corp. · Immunology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 1995
Decision
47d
Days
Class 2
Risk

K953014 is an FDA 510(k) clearance for the ALASTAT MICROPLATE LATEX-SPECIFIC IGE ALLERGEN. 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 15, 1995 after a review of 47 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 K953014 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 29, 1995
Decision Date August 15, 1995
Days to Decision 47 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
57d faster than avg
Panel avg: 104d · This submission: 47d
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 K953014.
SPECIFIC ALLERGEN MODULES FOR THE ALASTAT MICROPLATE ALLERGEN-SPECIFIC IGE SYSTEM
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ACCESS ALLERGEN DOG EPITHELIM
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QUICKVUE ONE-STEP ALLERGEN SCREEN
K950728 · Quidel Corp. · Oct 1995
SPECIFIC IGE ULTRA-EIA
K945884 · Hycor Biomedical, Inc. · Jun 1995
HYCOR SPECIFIC IGE ENZYME IMMUNOASSAY
K945748 · Hycor Biomedical, Inc. · Jun 1995
ACCESS ALLERGENS - FEMATOPHAGOIDES FARINAE, CAT DANDER, TIMOTHY GRASS, AND ALTERNARIA ALTERNATA WHICH ARE SPECIFIC IGEZR
K950629 · Bio-Rad Laboratories, Inc. · May 1995