Cleared Special

K033274 - GIARDIA II

K033274 is an FDA 510(k) clearance for GIARDIA II, manufactured by Techlab, Inc.. The device is a Class 2 Microbiology device with product code MHI cleared through the Special 510(k) pathway after a 25-day FDA review.

K033274 · Techlab, Inc. · Microbiology device
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Nov 2003
Decision
25d
Days
Class 2
Risk

K033274 is an FDA 510(k) clearance for the GIARDIA II. Classified as Giardia Spp. (product code MHI), Class II - Special Controls.

Submitted by Techlab, Inc. (Blacksburg, US). The FDA issued a Cleared decision on November 4, 2003 after a review of 25 days - a notably fast clearance cycle.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.3220 - the FDA microbiology device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K033274

510(k) Number K033274 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 10, 2003
Decision Date November 04, 2003
Days to Decision 25 days
Submission Type Special
Review Panel Microbiology (MI)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
77d faster than avg
Panel avg: 102d · This submission: 25d
Pathway characteristics
Modification to existing cleared device.

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 26
Devices cleared under the same product code (MHI) and FDA review panel - the closest regulatory comparables to K033274.
GIARDIA FECAL ANTIGEN DETECTION LATERAL FLOW KIT, MODEL GL-LF
K081064 · Ivd Research, Inc. · Jan 2009
XPECT GIARDIA LATERAL FLOW ASSAY, MODEL 2450020
K031942 · Remel, Inc. · Nov 2003
XPECT GIARDIA/CRYPTOSPORIDIUM LATERAL FLOW ASSAY
K031834 · Remel, Inc. · Nov 2003
IVD CRYPTO/GIARDIA DFA
K024113 · Ivd Research, Inc. · Mar 2003
IVD GIARDIA ANTIGEN DETECTION ASSAY MODEL GL-96
K020583 · Ivd Research, Inc. · Sep 2002
GIARDIA/CRYPTOSPORIDIUM COMBO RAPID ASSAY
K983399 · Genzyme Diagnostics · Jan 1999
K033274 · GIARDIA II
Download PDF Techlab, Inc.