Cleared Traditional

K813359 - MYCO-IMMUNE TM HISTOPLASMIN LATEX AGGL

K813359 is an FDA 510(k) clearance for MYCO-IMMUNE TM HISTOPLASMIN LATEX AGGL, manufactured by American Scientific Products. The device is a Class 2 Microbiology device with product code GMJ cleared through the Traditional 510(k) pathway after a 31-day FDA review.

K813359 · American Scientific Products · Microbiology device
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Dec 1981
Decision
31d
Days
Class 2
Risk

K813359 is an FDA 510(k) clearance for the MYCO-IMMUNE TM HISTOPLASMIN LATEX AGGL. Classified as Antigens, Histoplasma Capsulatum, All (product code GMJ), Class II - Special Controls.

Submitted by American Scientific Products (Mchenry, US). The FDA issued a Cleared decision on December 31, 1981 after a review of 31 days - a notably fast clearance cycle.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.3320 - 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

FDA 510(k) Submission Details - K813359

510(k) Number K813359 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 30, 1981
Decision Date December 31, 1981
Days to Decision 31 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
71d faster than avg
Panel avg: 102d · This submission: 31d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GMJ Device Classification - Class 2, Special Controls

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 Microbiology devices follow this clearance model.

Regulatory Peers - GMJ Antigens, Histoplasma Capsulatum, All

All 10
Devices cleared under the same product code (GMJ) and FDA review panel - the closest regulatory comparables to K813359.
LA-HISTO ANTIBODY SYSTEM #HL 1001
K830837 · Immuno-Mycologics, Inc. · May 1983
HISTOPLASMA CAPSULATUM, ANTIGEN
K792701 · Meridian Diagnostics, Inc. · Jan 1980
HISTOPLASMA CAPSULATUM, ANTIGEN YEAST
K792704 · Meridian Diagnostics, Inc. · Jan 1980
HISTOPLASMA CAPSULATUM, MYCELIAL PHASE
K792708 · Meridian Diagnostics, Inc. · Jan 1980
HISTOPLASMA CAPSULATUM, ANTISERUM
K792711 · Meridian Diagnostics, Inc. · Jan 1980
FUNGAL IMMUNODIFFUSION KIT #ID1001
K791384 · Immuno-Mycologics, Inc. · Aug 1979