Cleared Traditional

K931703 - IMMULITE TOTAL IGE

K931703 is an FDA 510(k) clearance for IMMULITE TOTAL IGE, manufactured by Diagnostic Products Corp.. The device is a Class 2 Immunology device with 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

FDA 510(k) Submission Details - K931703

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
27d slower than avg
Panel avg: 105d · This submission: 132d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JHR Device Classification - Class 2, Special Controls

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