Cleared Traditional

K944871 - LMD GIARDIA ANTIGEN DETECTION ASSAY

K944871 is the FDA 510(k) clearance for LMD GIARDIA ANTIGEN DETECTION ASSAY by Lmd Laboratories. It is a Class 2 Microbiology device (product code MHI) cleared through the Traditional 510(k) pathway after a 262-day FDA review.

K944871 · Lmd Laboratories · Microbiology device
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Optimized for regulatory review, auditing and printing
Jun 1995
Decision
262d
Days
Class 2
Risk

K944871 is an FDA 510(k) clearance for the LMD GIARDIA ANTIGEN DETECTION ASSAY. Classified as Giardia Spp. (product code MHI), Class II - Special Controls.

Submitted by Lmd Laboratories (Carlsbad, US). The FDA issued a Cleared decision on June 22, 1995 after a review of 262 days - an extended review 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: 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.

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Submission Details

510(k) Number K944871 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 03, 1994
Decision Date June 22, 1995
Days to Decision 262 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
160d slower than avg
Panel avg: 102d · This submission: 262d
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 K944871.
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