Cleared Traditional

K863973 - ELM ALLERGEN DISC

K863973 is the FDA 510(k) clearance for ELM ALLERGEN DISC by Immuno Nuclear Corp.. It is a Class 2 Immunology device (product code DHB) cleared through the Traditional 510(k) pathway after a 48-day FDA review.

K863973 · Immuno Nuclear Corp. · Immunology device
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Dec 1986
Decision
48d
Days
Class 2
Risk

K863973 is an FDA 510(k) clearance for the ELM ALLERGEN DISC. Classified as System, Test, Radioallergosorbent (rast) Immunological (product code DHB), Class II - Special Controls.

Submitted by Immuno Nuclear Corp. (Stillwater, US). The FDA issued a Cleared decision on December 1, 1986 after a review of 48 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 Immuno Nuclear Corp. devices

Submission Details

510(k) Number K863973 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 14, 1986
Decision Date December 01, 1986
Days to Decision 48 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
56d faster than avg
Panel avg: 104d · This submission: 48d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 200
Devices cleared under the same product code (DHB) and FDA review panel - the closest regulatory comparables to K863973.
ALLERGEN SPECIFIC CONTROLS
K870152 · 3M Company · Feb 1987
SPECIFIC IGE FAST(TM) TEST II
K863967 · 3M Company · Dec 1986
3M IGG4 FAST TEST PACKAGE
K863794 · 3M Company · Dec 1986
PHADEBAS RAST/PHADEZYM RAST ALLERTUBE
K863036 · Pharmacia, Inc. · Oct 1986
PHADIOTOP (TM) RIA/PHADIOTOP (TM) EIA
K863355 · Pharmacia, Inc. · Sep 1986
VENTRESCREEN II POLLENS ENZYME IMMUNOASSAY
K862901 · Ventrex Laboratories, Inc. · Sep 1986