Cleared Traditional

K963245 - IMMULITE LATEX-SPECIFIC IGE

K963245 is an FDA 510(k) clearance for IMMULITE LATEX-SPECIFIC IGE, 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 91-day FDA review.

K963245 · Diagnostic Products Corp. · Immunology device
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Nov 1996
Decision
91d
Days
Class 2
Risk

K963245 is an FDA 510(k) clearance for the IMMULITE LATEX-SPECIFIC IGE. 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 November 18, 1996 after a review of 91 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 - K963245

510(k) Number K963245 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 19, 1996
Decision Date November 18, 1996
Days to Decision 91 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
14d faster than avg
Panel avg: 105d · This submission: 91d
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 K963245.
UNICAP SPECIFIC IGE FEIA ASSAY, LATEX ALLERGEN IMMUNOCAP K82
K972068 · Pharmacia, Inc. · Jul 1997
HYCOR ALLERGEN DISC
K965094 · Hycor Biomedical, Inc. · May 1997
PHARMACIA CAP SYSTEM RAST FEIA
K962976 · Pharmacia & Upjohn Co. · Dec 1996
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