Cleared Traditional

K792713 - CANDIDA ALBICANS, ANTISERUM

K792713 is an FDA 510(k) clearance for CANDIDA ALBICANS, manufactured by Meridian Diagnostics, Inc.. The device is a Class 2 Microbiology device with product code GMI cleared through the Traditional 510(k) pathway after a 27-day FDA review.

K792713 · Meridian Diagnostics, Inc. · Microbiology device
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Jan 1980
Decision
27d
Days
Class 2
Risk

K792713 is an FDA 510(k) clearance for the CANDIDA ALBICANS, ANTISERUM. Classified as Antigen, Cf And / Or Id, Coccidioides Immitis (product code GMI), Class II - Special Controls.

Submitted by Meridian Diagnostics, Inc. (Mchenry, US). The FDA issued a Cleared decision on January 23, 1980 after a review of 27 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 Meridian Diagnostics, Inc. devices

FDA 510(k) Submission Details - K792713

510(k) Number K792713 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 27, 1979
Decision Date January 23, 1980
Days to Decision 27 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
75d faster than avg
Panel avg: 102d · This submission: 27d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GMI Device Classification - Class 2, Special Controls

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

All 8
Devices cleared under the same product code (GMI) and FDA review panel - the closest regulatory comparables to K792713.
COCCIDIOIDES IMMUNODIFFUSION SYSTEM
K812190 · American Scientific Products · Aug 1981
FUNGAL IMMUNODIFFUSION SYSTEM
K812185 · American Scientific Products · Aug 1981
CANDIDA ALBICANS, ANTIGEN
K792716 · 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 #CA1001
K791383 · Immuno-Mycologics, Inc. · Aug 1979