Cleared Traditional

K983954 - ALASTAT MICROPLATE MIXED ALLERGEN PANELS

K983954 is the FDA 510(k) clearance for ALASTAT MICROPLATE MIXED ALLERGEN PANELS by Diagnostic Products Corp.. It is a Class 2 Immunology device (product code DHB) cleared through the Traditional 510(k) pathway after a 42-day FDA review.

K983954 · Diagnostic Products Corp. · Immunology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 1998
Decision
42d
Days
Class 2
Risk

K983954 is an FDA 510(k) clearance for the ALASTAT MICROPLATE MIXED ALLERGEN PANELS. 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 17, 1998 after a review of 42 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 K983954 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 05, 1998
Decision Date December 17, 1998
Days to Decision 42 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
62d faster than avg
Panel avg: 104d · This submission: 42d
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 K983954.
IMMULITE 2000 MIXED ALLERGEN PANELS
K021208 · Diagnostic Products Corp. · May 2002
IMMUNLITE 2000 ALLERGEN-SPECIFIC IGE AND MIXED ALLERGEN PANELS, MODEL L2KUN6 (600 TESTS)
K013135 · Diagnostic Products Corp. · Oct 2001
IMMULITE 2000 ALLERGEN-SPECIFIC IGE AND SPECIFIC ALLERGENS, MDOEL L2KUN6 (600 TESTS)
K013134 · Diagnostic Products Corp. · Oct 2001
ALLERGAN IMMUNO CAP M4, M8, K70
K974350 · Pharmacia, Inc. · Feb 1998
IMMULITE CAT-SPECIFIC IGE, IMMULITE DOG-SPECIFIC IGE,IMMULITE MITE-SPECIFIC IGE
K973186 · Diagnostic Products Corp. · Sep 1997
UNICAP PHADIATOP
K972364 · Pharmacia, Inc. · Sep 1997