Cleared Traditional

K812185 - FUNGAL IMMUNODIFFUSION SYSTEM

K812185 is the FDA 510(k) clearance for FUNGAL IMMUNODIFFUSION SYSTEM by American Scientific Products. It is a Class 2 Microbiology device (product code GMI) cleared through the Traditional 510(k) pathway after a 22-day FDA review.

K812185 · American Scientific Products · Microbiology device
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Aug 1981
Decision
22d
Days
Class 2
Risk

K812185 is an FDA 510(k) clearance for the FUNGAL IMMUNODIFFUSION SYSTEM. Classified as Antigen, Cf And / Or Id, Coccidioides Immitis (product code GMI), Class II - Special Controls.

Submitted by American Scientific Products (Mchenry, US). The FDA issued a Cleared decision on August 25, 1981 after a review of 22 days - a notably fast clearance cycle.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.3135 - the FDA microbiology 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 American Scientific Products devices

Submission Details

510(k) Number K812185 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 03, 1981
Decision Date August 25, 1981
Days to Decision 22 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
80d faster than avg
Panel avg: 102d · This submission: 22d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code GMI Antigen, Cf And / Or Id, Coccidioides Immitis
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.3135
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 Microbiology devices follow this clearance model.

Regulatory Peers - GMI Antigen, Cf And / Or Id, Coccidioides Immitis

Devices cleared under the same product code (GMI) and FDA review panel - the closest regulatory comparables to K812185.
CANDIDA ALBICANS, ANTIGEN
K792716 · Meridian Diagnostics, Inc. · Jan 1980
CANDIDA ALBICANS, ANTISERUM
K792713 · Meridian Diagnostics, Inc. · Jan 1980
COCCIDIOIDES IMMITIS, ANTIGEN
K792682 · Meridian Diagnostics, Inc. · Jan 1980
COCCIDIOIDES IMMITIS, ANTIGEN
K792689 · Meridian Diagnostics, Inc. · Jan 1980
CANDIDA IMMUNODIFFUSION KIT
K770527 · I M, Inc. · Mar 1978