Cleared Traditional

K933997 - PROSPECT ENTAMOEBA HISTOLYTICA MICROPLATE ASSAY

K933997 is an FDA 510(k) clearance for PROSPECT ENTAMOEBA HISTOLYTICA MICROPLA..., manufactured by Alexon Biomedical, Inc.. The device is a Class 2 Microbiology device with product code GMD cleared through the Traditional 510(k) pathway after a 97-day FDA review.

K933997 · Alexon Biomedical, Inc. · Microbiology device
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Nov 1993
Decision
97d
Days
Class 2
Risk

K933997 is an FDA 510(k) clearance for the PROSPECT ENTAMOEBA HISTOLYTICA MICROPLATE ASSAY. Classified as Antisera, Latex Agglutination, Cryptococcus Neoformans (product code GMD), Class II - Special Controls.

Submitted by Alexon Biomedical, Inc. (Sunnyvale, US). The FDA issued a Cleared decision on November 22, 1993 after a review of 97 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Microbiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Alexon Biomedical, Inc. devices

FDA 510(k) Submission Details - K933997

510(k) Number K933997 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 17, 1993
Decision Date November 22, 1993
Days to Decision 97 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
5d faster than avg
Panel avg: 102d · This submission: 97d
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 9
Devices cleared under the same product code (GMD) and FDA review panel - the closest regulatory comparables to K933997.
CRAG LATERAL FLOW ASSAY (LFA)
K112422 · Immuno-Mycologics, Inc. · Mar 2012
CRAG LATERAL FLOW ASSAY (CRAG LFA)
K102286 · Immuno-Mycologics, Inc. · Jul 2011
CRYPTO-LEX SYSTEM
K930418 · Trinity Laboratories, Inc. · Feb 1994
(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