Cleared Traditional

K081064 - GIARDIA FECAL ANTIGEN DETECTION LATERAL FLOW KIT, MODEL GL-LF

K081064 is an FDA 510(k) clearance for GIARDIA FECAL ANTIGEN DETECTION LATERAL..., manufactured by Ivd Research, Inc.. The device is a Class 2 Microbiology device with product code MHI cleared through the Traditional 510(k) pathway after a 275-day FDA review.

K081064 · Ivd Research, Inc. · Microbiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 2009
Decision
275d
Days
Class 2
Risk

K081064 is an FDA 510(k) clearance for the GIARDIA FECAL ANTIGEN DETECTION LATERAL FLOW KIT, MODEL GL-LF. Classified as Giardia Spp. (product code MHI), Class II - Special Controls.

Submitted by Ivd Research, Inc. (Tucson, US). The FDA issued a Cleared decision on January 14, 2009 after a review of 275 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.

View all Ivd Research, Inc. devices

FDA 510(k) Submission Details - K081064

510(k) Number K081064 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 14, 2008
Decision Date January 14, 2009
Days to Decision 275 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
173d slower than avg
Panel avg: 102d · This submission: 275d
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.

All 12
Devices cleared under the same product code (MHI) and FDA review panel - the closest regulatory comparables to K081064.
UNIGOLD GIARDIA
K120001 · Trinity Biotech · Mar 2013
GIARDIA/ CRYPTOSPORIDIUM QUIK CHEK
K103673 · Techlab Inc., Corporate Research Center · Aug 2011
XPECT GIARDIA LATERAL FLOW ASSAY, MODEL 2450020
K031942 · Remel, Inc. · Nov 2003
XPECT GIARDIA/CRYPTOSPORIDIUM LATERAL FLOW ASSAY
K031834 · Remel, Inc. · Nov 2003
GIARDIA II
K033274 · Techlab, Inc. · Nov 2003
GIARDIA/CRYPTOSPORIDIUM COMBO RAPID ASSAY
K983399 · Genzyme Diagnostics · Jan 1999