Cleared Traditional

K860033 - EIA MONOCLONAL TOTAL IGE KIT

K860033 is the FDA 510(k) clearance for EIA MONOCLONAL TOTAL IGE KIT by Diagnostic Products Corp.. It is a Class 2 Immunology device (product code DGC) cleared through the Traditional 510(k) pathway after a 91-day FDA review.

K860033 · Diagnostic Products Corp. · Immunology device
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Apr 1986
Decision
91d
Days
Class 2
Risk

K860033 is an FDA 510(k) clearance for the EIA MONOCLONAL TOTAL IGE KIT. Classified as Ige, Antigen, Antiserum, Control (product code DGC), Class II - Special Controls.

Submitted by Diagnostic Products Corp. (Los Angeles, US). The FDA issued a Cleared decision on April 7, 1986 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 866.5510 - 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

Submission Details

510(k) Number K860033 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 06, 1986
Decision Date April 07, 1986
Days to Decision 91 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
13d faster than avg
Panel avg: 104d · This submission: 91d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DGC Ige, Antigen, Antiserum, Control
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.5510
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 - DGC Ige, Antigen, Antiserum, Control

All 75
Devices cleared under the same product code (DGC) and FDA review panel - the closest regulatory comparables to K860033.
ENZYMUN-TEST(R) IGE
K863822 · Boehringer Mannheim Corp. · Oct 1986
QUIDEL ALLERGY SCREEN
K861171 · Quidel Corp. · Apr 1986
TOTAL IGE-IRMA RIA KIT
K860032 · Diagnostic Products Corp. · Apr 1986
THE DPC MONOCLONAL EIA TOTAL IGE KIT
K852878 · Diagnostic Products Corp. · Aug 1985
QUANTICLONE IGE RADIOIMMUNASSAY
K852268 · Kallestad Laboratories, Inc. · Jul 1985
PHARMACIA IGE RIA MODIFIED
K851156 · Pharmacia, Inc. · Apr 1985