Cleared Special

GIARDIA II (K033274) - FDA 510(k) Clearance

Class II Microbiology device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K033274 · Techlab, Inc. · Microbiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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.

View all Techlab, Inc. devices

Submission Details

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
Regulatory Context
Review time vs. panel average
77d faster than avg
Panel avg: 102d · This submission: 25d
Pathway characteristics
Modification to existing cleared device.

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.