Cleared Traditional

K121565 - UNI-GOLD CRYPTOSPORIDIUM

K121565 is an FDA 510(k) clearance for UNI-GOLD CRYPTOSPORIDIUM, manufactured by Trinity Biotech. The device is a Class 2 Microbiology device with product code MHJ cleared through the Traditional 510(k) pathway after a 255-day FDA review.

K121565 · Trinity Biotech · Microbiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2013
Decision
255d
Days
Class 2
Risk

K121565 is an FDA 510(k) clearance for the UNI-GOLD CRYPTOSPORIDIUM. Classified as Cryptosporidium Spp. (product code MHJ), Class II - Special Controls.

Submitted by Trinity Biotech (Carlsbad, US). The FDA issued a Cleared decision on February 8, 2013 after a review of 255 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 Trinity Biotech devices

FDA 510(k) Submission Details - K121565

510(k) Number K121565 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 29, 2012
Decision Date February 08, 2013
Days to Decision 255 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
153d slower than avg
Panel avg: 102d · This submission: 255d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MHJ Device Classification - Class 2, Special Controls

Product Code MHJ Cryptosporidium 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 - MHJ Cryptosporidium Spp.

All 10
Devices cleared under the same product code (MHJ) and FDA review panel - the closest regulatory comparables to K121565.
TRI-COMBO PARASITE SCREEN
K171078 · Techlab, Inc. · Jul 2017
GIARDIA/CRYPTOSPORIDIUM CHEK
K051929 · Techlab, Inc. · Nov 2005
CRYPTOSPORIDIUM II
K052932 · Techlab, Inc. · Nov 2005
XPECT CRYPTOSPORIDIUM LATERAL FLOW ASSAY, MODEL 2451020
K031965 · Remel, Inc. · Nov 2003
PREMIER CRYPTOSPORIDIUM
K982764 · Meridian Diagnostics, Inc. · Dec 1998
MODIFICATION TO PROSPECT CRYPTOSPORIDIUM MICROTITER ASSAY
K982709 · Alexon - Trend, Inc. · Sep 1998