Cleared Traditional

K020387 - MYALLERGYTEST SYSTEM

K020387 is an FDA 510(k) clearance for MYALLERGYTEST SYSTEM, manufactured by Immunetech Corporation. The device is a Class 2 Immunology device with product code DHB cleared through the Traditional 510(k) pathway after a 71-day FDA review.

K020387 · Immunetech Corporation · Immunology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2002
Decision
71d
Days
Class 2
Risk

K020387 is an FDA 510(k) clearance for the MYALLERGYTEST SYSTEM. Classified as System, Test, Radioallergosorbent (rast) Immunological (product code DHB), Class II - Special Controls.

Submitted by Immunetech Corporation (Rancho Santa Fe, US). The FDA issued a Cleared decision on April 17, 2002 after a review of 71 days - a notably fast clearance cycle.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 866.5750 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Immunetech Corporation devices

FDA 510(k) Submission Details - K020387

510(k) Number K020387 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 05, 2002
Decision Date April 17, 2002
Days to Decision 71 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
34d faster than avg
Panel avg: 105d · This submission: 71d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DHB Device Classification - Class 2, Special Controls

Product Code DHB System, Test, Radioallergosorbent (rast) Immunological
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.5750
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 - DHB System, Test, Radioallergosorbent (rast) Immunological

All 231
Devices cleared under the same product code (DHB) and FDA review panel - the closest regulatory comparables to K020387.
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