Cleared Traditional

K874849 - PROSPECT/GIARDIA

K874849 is the FDA 510(k) clearance for PROSPECT/GIARDIA by Alexon Biomedical, Inc.. It is a Class 2 Microbiology device (product code KHW) cleared through the Traditional 510(k) pathway after a 41-day FDA review.

K874849 · Alexon Biomedical, Inc. · Microbiology device
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Jan 1988
Decision
41d
Days
Class 2
Risk

K874849 is an FDA 510(k) clearance for the PROSPECT/GIARDIA. Classified as Antigen, Id, Ha, Cep, Entamoeba Histolytica & Rel. Spp. (product code KHW), Class II - Special Controls.

Submitted by Alexon Biomedical, Inc. (Glen Ellyn, US). The FDA issued a Cleared decision on January 5, 1988 after a review of 41 days - a notably fast clearance cycle.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.3220 - 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 Alexon Biomedical, Inc. devices

Submission Details

510(k) Number K874849 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 25, 1987
Decision Date January 05, 1988
Days to Decision 41 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
61d faster than avg
Panel avg: 102d · This submission: 41d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code KHW Antigen, Id, Ha, Cep, Entamoeba Histolytica & Rel. Spp.
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.3220
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 - KHW Antigen, Id, Ha, Cep, Entamoeba Histolytica & Rel. Spp.

All 8
Devices cleared under the same product code (KHW) and FDA review panel - the closest regulatory comparables to K874849.
E. HISTOLYTICA II
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E. HISTOLYTICA TEST
K955895 · Techlab, Inc. · Aug 1996
ENTAMOEBA TEST
K944791 · Techlab, Inc. · Mar 1995
AMEBIASIS MICROASSAY
K863811 · Diamedix Corp. · Oct 1986
PDQ AMEBIASIS
K862473 · Diamedix Corp. · Aug 1986
HILLCREST AMEBIASIS IHA TEST
K853448 · Hillcrest Biologicals · Aug 1985