Cleared Traditional

K955157 - PROSPECT GIARDIA/CRYPTOSPORIDIUM MICROP...

K955157 is the FDA 510(k) clearance for PROSPECT GIARDIA/CRYPTOSPORIDIUM MICROP... by Alexon Biomedical, Inc.. It is a Class 2 Microbiology device (product code MHI) cleared through the Traditional 510(k) pathway after a 88-day FDA review.

K955157 · Alexon Biomedical, Inc. · Microbiology device
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Feb 1996
Decision
88d
Days
Class 2
Risk

K955157 is an FDA 510(k) clearance for the PROSPECT GIARDIA/CRYPTOSPORIDIUM MICROPLATE ASSAY. Classified as Giardia Spp. (product code MHI), Class II - Special Controls.

Submitted by Alexon Biomedical, Inc. (Sunnyvale, US). The FDA issued a Cleared decision on February 9, 1996 after a review of 88 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 K955157 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 13, 1995
Decision Date February 09, 1996
Days to Decision 88 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
14d faster than avg
Panel avg: 102d · This submission: 88d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code MHI Giardia 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 - MHI Giardia Spp.

Devices cleared under the same product code (MHI) and FDA review panel - the closest regulatory comparables to K955157.
TRIAGE,PARASITE PANEL, TRIAGE CRYPTOSPORIDIUM AND ENTAMOEBA HISTOLYTICA, TRIAGE CRYPTOSPORIDIUM AND GIARDIA LAMBLIA
K982245 · Biosite Incorporated · Oct 1998
GIARDIA CELISA
K963135 · Techlab, Inc. · Nov 1996
CRYPTO/GIARDIA-CEL IF TEST
K955897 · Techlab, Inc. · Aug 1996
MERIFLUOR-CRYPTOSPORIDIUM/GIARDIA
K912408 · Meridian Diagnostics, Inc. · Jul 1991