Cleared Traditional

K031942 - XPECT GIARDIA LATERAL FLOW ASSAY

K031942 is an FDA 510(k) clearance for XPECT GIARDIA LATERAL FLOW ASSAY, manufactured by Remel, Inc.. The device is a Class 2 Microbiology device with product code MHI cleared through the Traditional 510(k) pathway after a 147-day FDA review.

K031942 · Remel, Inc. · Microbiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 2003
Decision
147d
Days
Class 2
Risk

K031942 is an FDA 510(k) clearance for the XPECT GIARDIA LATERAL FLOW ASSAY, MODEL 2450020. Classified as Giardia Spp. (product code MHI), Class II - Special Controls.

Submitted by Remel, Inc. (Ramsey, US). The FDA issued a Cleared decision on November 18, 2003 after a review of 147 days - within the typical 510(k) review window.

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.

View all Remel, Inc. devices

FDA 510(k) Submission Details - K031942

510(k) Number K031942 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 24, 2003
Decision Date November 18, 2003
Days to Decision 147 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
45d slower than avg
Panel avg: 102d · This submission: 147d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MHI Device Classification - Class 2, Special Controls

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 K031942.
GIARDIA II
K033274 · Techlab, Inc. · Nov 2003
PREMIER GIARDIA
K982711 · Meridian Diagnostics, Inc. · Nov 1998
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