Cleared Traditional

K812188 - CRYPTOCOCCAL ANTIGEN LATEX AGGLUTI

K812188 is the FDA 510(k) clearance for CRYPTOCOCCAL ANTIGEN LATEX AGGLUTI by American Scientific Products. It is a Class 2 Microbiology device (product code GMD) cleared through the Traditional 510(k) pathway after a 28-day FDA review.

K812188 · American Scientific Products · Microbiology device
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Aug 1981
Decision
28d
Days
Class 2
Risk

K812188 is an FDA 510(k) clearance for the CRYPTOCOCCAL ANTIGEN LATEX AGGLUTI. Classified as Antisera, Latex Agglutination, Cryptococcus Neoformans (product code GMD), Class II - Special Controls.

Submitted by American Scientific Products (Mchenry, US). The FDA issued a Cleared decision on August 31, 1981 after a review of 28 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 American Scientific Products devices

Submission Details

510(k) Number K812188 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 03, 1981
Decision Date August 31, 1981
Days to Decision 28 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
74d faster than avg
Panel avg: 102d · This submission: 28d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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

Devices cleared under the same product code (GMD) and FDA review panel - the closest regulatory comparables to K812188.
CRYPTO-LEX SYSTEM
K930418 · Trinity Laboratories, Inc. · Feb 1994
(CALAS(TM)) W/ADD'L REAGENT CALAS(TM) PRONASE
K894845 · Meridian Diagnostics, Inc. · Sep 1989
CRYPTOCOCCUS NEOFORMANS ANTISERUM, LATEX
K792693 · Meridian Diagnostics, Inc. · Jan 1980
CRYPTOCOCCAL ANTIGEN LATEX AGG. SYSTEM
K780526 · I M, Inc. · Apr 1978