Cleared Traditional

K120001 - UNIGOLD GIARDIA (FDA 510(k) Clearance)

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

K120001 · Trinity Biotech · Microbiology device
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Mar 2013
Decision
423d
Days
Class 2
Risk

K120001 is an FDA 510(k) clearance for the UNIGOLD GIARDIA. Classified as Giardia Spp. (product code MHI), Class II - Special Controls.

Submitted by Trinity Biotech (Carlsbad, US). The FDA issued a Cleared decision on March 1, 2013 after a review of 423 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Microbiology submissions.

View all Trinity Biotech devices

Submission Details

510(k) Number K120001 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 03, 2012
Decision Date March 01, 2013
Days to Decision 423 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
321d slower than avg
Panel avg: 102d · This submission: 423d
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.