Cleared Traditional

K953284 - TREND GIARDIA DIRECT DETECTION RS TEST SYSTEM

K953284 is an FDA 510(k) clearance for TREND GIARDIA DIRECT DETECTION RS TEST ..., manufactured by Trend Scientific, Inc.. The device is a Class 2 Microbiology device with product code MHI cleared through the Traditional 510(k) pathway after a 85-day FDA review.

K953284 · Trend Scientific, Inc. · Microbiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Oct 1995
Decision
85d
Days
Class 2
Risk

K953284 is an FDA 510(k) clearance for the TREND GIARDIA DIRECT DETECTION RS TEST SYSTEM. Classified as Giardia Spp. (product code MHI), Class II - Special Controls.

Submitted by Trend Scientific, Inc. (New Brighton, US). The FDA issued a Cleared decision on October 6, 1995 after a review of 85 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

FDA 510(k) Submission Details - K953284

510(k) Number K953284 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 13, 1995
Decision Date October 06, 1995
Days to Decision 85 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
17d faster than avg
Panel avg: 102d · This submission: 85d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 K953284.
CRYPTO/GIARDIA-CEL IF TEST
K955897 · Techlab, Inc. · Aug 1996
PROSPECT GIARDIA/CRYPTOSPORIDIUM MICROPLATE ASSAY
K955157 · Alexon Biomedical, Inc. · Feb 1996
TREND GIARDIA LAMBLIA DIRECT DETECTION SYSTEM (MODIFIED KIT)
K952467 · Trend Scientific, Inc. · Nov 1995
LMD GIARDIA ANTIGEN DETECTION ASSAY
K944871 · Lmd Laboratories · Jun 1995
PROSPECT GIARDIA
K942098 · Alexon, Inc. · Sep 1994
PROSPECT(TM) GIARDIA RAPID ASSAY, MODIFICATION
K931147 · Alexon, Inc. · May 1993
K953284 · TREND GIARDIA DIRECT DETECTION RS TEST SYSTEM
Download PDF FDA Summary Trend Scientific, Inc.