Cleared Traditional

K931703 - IMMULITE TOTAL IGE

K931703 is the FDA 510(k) clearance for IMMULITE TOTAL IGE by Diagnostic Products Corp.. It is a Class 2 Immunology device (product code JHR) cleared through the Traditional 510(k) pathway after a 132-day FDA review.

K931703 · Diagnostic Products Corp. · Immunology device
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Aug 1993
Decision
132d
Days
Class 2
Risk

K931703 is an FDA 510(k) clearance for the IMMULITE TOTAL IGE. Classified as Radioimmunoassay, Immunoglobulins (d, E) (product code JHR), Class II - Special Controls.

Submitted by Diagnostic Products Corp. (Los Angeles, US). The FDA issued a Cleared decision on August 16, 1993 after a review of 132 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 K931703 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 06, 1993
Decision Date August 16, 1993
Days to Decision 132 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
28d slower than avg
Panel avg: 104d · This submission: 132d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code JHR Radioimmunoassay, Immunoglobulins (d, E)
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 - JHR Radioimmunoassay, Immunoglobulins (d, E)

All 7
Devices cleared under the same product code (JHR) and FDA review panel - the closest regulatory comparables to K931703.
ELECSYS IGE II IMMUNOASSAY
K061970 · Roche Diagnostics · Aug 2006
ELECYS IGE ASSAY
K984326 · Boehringer Mannheim Corp. · Feb 1999
IMMILITE TOTAL IGE
K960067 · Diagnostic Products Corp. · Feb 1996
TURBO-RAST SPECIFIC IGE ASSAY
K903000 · Ventrex Laboratories, Inc. · Jul 1990
COAT-A-COUNT TOTAL IGE IRMA, CATALOG #IKIE1, IKIE2
K901859 · Diagnostic Products Corp. · May 1990
ALTERNATE PROCEDURE, PHARMACIA IGE EIA
K882616 · Pharmacia, Inc. · Aug 1988