Cleared Traditional

K020583 - IVD GIARDIA ANTIGEN DETECTION ASSAY MODEL GL-96

K020583 is an FDA 510(k) clearance for IVD GIARDIA ANTIGEN DETECTION ASSAY MOD..., 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 208-day FDA review.

K020583 · Ivd Research, Inc. · Microbiology device
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Sep 2002
Decision
208d
Days
Class 2
Risk

K020583 is an FDA 510(k) clearance for the IVD GIARDIA ANTIGEN DETECTION ASSAY MODEL GL-96. Classified as Giardia Spp. (product code MHI), Class II - Special Controls.

Submitted by Ivd Research, Inc. (Carlsbad, US). The FDA issued a Cleared decision on September 17, 2002 after a review of 208 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 - K020583

510(k) Number K020583 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 21, 2002
Decision Date September 17, 2002
Days to Decision 208 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
106d slower than avg
Panel avg: 102d · This submission: 208d
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 K020583.
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
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