Cleared Special

K061970 - ELECSYS IGE II IMMUNOASSAY

K061970 is the FDA 510(k) clearance for ELECSYS IGE II IMMUNOASSAY by Roche Diagnostics. It is a Class 2 Immunology device (product code JHR) cleared through the Special 510(k) pathway after a 50-day FDA review.

K061970 · Roche Diagnostics · Immunology device
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Aug 2006
Decision
50d
Days
Class 2
Risk

K061970 is an FDA 510(k) clearance for the ELECSYS IGE II IMMUNOASSAY. Classified as Radioimmunoassay, Immunoglobulins (d, E) (product code JHR), Class II - Special Controls.

Submitted by Roche Diagnostics (Indianapolis, US). The FDA issued a Cleared decision on August 31, 2006 after a review of 50 days - a notably fast clearance cycle.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 866.5510 - the FDA immunology device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Roche Diagnostics devices

Submission Details

510(k) Number K061970 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 12, 2006
Decision Date August 31, 2006
Days to Decision 50 days
Submission Type Special
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
54d faster than avg
Panel avg: 104d · This submission: 50d
Pathway characteristics
Modification to existing cleared device.

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 K061970.
ELECYS IGE ASSAY
K984326 · Boehringer Mannheim Corp. · Feb 1999
IMMILITE TOTAL IGE
K960067 · Diagnostic Products Corp. · Feb 1996
IMMULITE TOTAL IGE
K931703 · Diagnostic Products Corp. · Aug 1993
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