Cleared Special

MODIFICATION TO MYALLERGY TEST (K061979) - FDA 510(k) Clearance

Class II Immunology device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K061979 · Immunetech Corporation · Immunology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2006
Decision
71d
Days
Class 2
Risk

K061979 is an FDA 510(k) clearance for the MODIFICATION TO MYALLERGY TEST. Classified as Tubes, Vials, Systems, Serum Separators, Blood Collection (product code JKA), Class II - Special Controls.

Submitted by Immunetech Corporation (Menlo Park, US). The FDA issued a Cleared decision on September 22, 2006 after a review of 71 days - a notably fast clearance cycle.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 862.1675 - 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 Immunetech Corporation devices

Submission Details

510(k) Number K061979 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 13, 2006
Decision Date September 22, 2006
Days to Decision 71 days
Submission Type Special
Review Panel Immunology (IM)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
33d faster than avg
Panel avg: 104d · This submission: 71d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code JKA Tubes, Vials, Systems, Serum Separators, Blood Collection
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1675
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 - JKA Tubes, Vials, Systems, Serum Separators, Blood Collection

All 236
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