Cleared Traditional

GIARDIA FECAL ANTIGEN DETECTION LATERAL FLOW KIT, MODEL GL-LF (K081064) - FDA 510(k) Clearance

Class II Microbiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

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

Submission Details

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.

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.