Cleared Traditional

K021698 - MY ALLERGY TEST

K021698 is an FDA 510(k) clearance for MY ALLERGY TEST, manufactured by Immunetech Corporation. The device is a Class 2 Immunology device with product code JKA cleared through the Traditional 510(k) pathway after a 120-day FDA review.

K021698 · Immunetech Corporation · Immunology device
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Sep 2002
Decision
120d
Days
Class 2
Risk

K021698 is an FDA 510(k) clearance for the MY ALLERGY TEST. Classified as Tubes, Vials, Systems, Serum Separators, Blood Collection (product code JKA), Class II - Special Controls.

Submitted by Immunetech Corporation (Rancho Santa Fe, US). The FDA issued a Cleared decision on September 19, 2002 after a review of 120 days - within the typical 510(k) review window.

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

FDA 510(k) Submission Details - K021698

510(k) Number K021698 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 22, 2002
Decision Date September 19, 2002
Days to Decision 120 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
15d slower than avg
Panel avg: 105d · This submission: 120d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JKA Device Classification - Class 2, Special Controls

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 155
Devices cleared under the same product code (JKA) and FDA review panel - the closest regulatory comparables to K021698.
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