Cleared Traditional

K860032 - TOTAL IGE-IRMA RIA KIT

K860032 is an FDA 510(k) clearance for TOTAL IGE-IRMA RIA KIT, manufactured by Diagnostic Products Corp.. The device is a Class 2 Immunology device with product code DGC cleared through the Traditional 510(k) pathway after a 95-day FDA review.

K860032 · Diagnostic Products Corp. · Immunology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 1986
Decision
95d
Days
Class 2
Risk

K860032 is an FDA 510(k) clearance for the TOTAL IGE-IRMA RIA 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 11, 1986 after a review of 95 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

FDA 510(k) Submission Details - K860032

510(k) Number K860032 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 06, 1986
Decision Date April 11, 1986
Days to Decision 95 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
10d faster than avg
Panel avg: 105d · This submission: 95d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DGC Device Classification - Class 2, Special Controls

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 90
Devices cleared under the same product code (DGC) and FDA review panel - the closest regulatory comparables to K860032.
ENZYMUN-TEST(R) IGE
K863822 · Boehringer Mannheim Corp. · Oct 1986
TIMOTHY ALLERGEN DISC
K862174 · Immuno Nuclear Corp. · Aug 1986
QUIDEL ALLERGY SCREEN
K861171 · Quidel Corp. · Apr 1986
EIA MONOCLONAL TOTAL IGE KIT
K860033 · 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