Cleared Traditional

K792693 - CRYPTOCOCCUS NEOFORMANS ANTISERUM, LATEX

K792693 is an FDA 510(k) clearance for CRYPTOCOCCUS NEOFORMANS ANTISERUM, manufactured by Meridian Diagnostics, Inc.. The device is a Class 2 Microbiology device with product code GMD cleared through the Traditional 510(k) pathway after a 25-day FDA review.

K792693 · Meridian Diagnostics, Inc. · Microbiology device
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Jan 1980
Decision
25d
Days
Class 2
Risk

K792693 is an FDA 510(k) clearance for the CRYPTOCOCCUS NEOFORMANS ANTISERUM, LATEX. Classified as Antisera, Latex Agglutination, Cryptococcus Neoformans (product code GMD), Class II - Special Controls.

Submitted by Meridian Diagnostics, Inc. (Mchenry, US). The FDA issued a Cleared decision on January 21, 1980 after a review of 25 days - a notably fast clearance cycle.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.3165 - 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 - K792693

510(k) Number K792693 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 27, 1979
Decision Date January 21, 1980
Days to Decision 25 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
77d faster than avg
Panel avg: 102d · This submission: 25d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GMD Device Classification - Class 2, Special Controls

Product Code GMD Antisera, Latex Agglutination, Cryptococcus Neoformans
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.3165
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 - GMD Antisera, Latex Agglutination, Cryptococcus Neoformans

All 8
Devices cleared under the same product code (GMD) and FDA review panel - the closest regulatory comparables to K792693.
(CALAS(TM)) W/ADD'L REAGENT CALAS(TM) PRONASE
K894845 · Meridian Diagnostics, Inc. · Sep 1989
CRYPTOCOCCAL ANTIGEN LATEX AGGLUTI
K812188 · American Scientific Products · Aug 1981
YA-CRYPTO ANTIBODY TUBE AGGLUTINATION
K810510 · Immuno-Mycologics, Inc. · Mar 1981
CRYPTOCOCCAL ANTIGEN LATEX AGGLUTINATION
K791382 · Immuno-Mycologics, Inc. · Aug 1979
CRYPTOCOCCAL ANTIGEN LATEX AGG. SYSTEM
K780526 · I M, Inc. · Apr 1978