Cleared Traditional

ASPERGILLUS MYCELIAL ANTIGEN (K760830) - FDA 510(k) Clearance

Class I Immunology device.

K760830 · I M, Inc. · Immunology device
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Nov 1976
Decision
19d
Days
Class 1
Risk

K760830 is an FDA 510(k) clearance for the ASPERGILLUS MYCELIAL ANTIGEN. Classified as Antigen, Cf, Aspergillus Spp. (product code JWT), Class I - General Controls.

Submitted by I M, Inc. (Mchenry, US). The FDA issued a Cleared decision on November 1, 1976 after a review of 19 days - a notably fast clearance cycle.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 866.3040 - 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 I M, Inc. devices

Submission Details

510(k) Number K760830 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 13, 1976
Decision Date November 01, 1976
Days to Decision 19 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
85d faster than avg
Panel avg: 104d · This submission: 19d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code JWT Antigen, Cf, Aspergillus Spp.
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 866.3040
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.