Cleared Traditional

K760827 - HISTOPLASMA YEAST ANTIGEN

K760827 is the FDA 510(k) clearance for HISTOPLASMA YEAST ANTIGEN by I M, Inc.. It is a Class 2 Immunology device (product code GMJ) cleared through the Traditional 510(k) pathway after a 19-day FDA review.

K760827 · I M, Inc. · Immunology device
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Nov 1976
Decision
19d
Days
Class 2
Risk

K760827 is an FDA 510(k) clearance for the HISTOPLASMA YEAST ANTIGEN. Classified as Antigens, Histoplasma Capsulatum, All (product code GMJ), Class II - Special 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 866.3320 - 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 K760827 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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
85d faster than avg
Panel avg: 104d · This submission: 19d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code GMJ Antigens, Histoplasma Capsulatum, All
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.3320
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.