Cleared Traditional

IVD GIARDIA ANTIGEN DETECTION ASSAY MODEL GL-96 (K020583) - FDA 510(k) Clearance

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

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

Submission Details

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.

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.