Cleared Traditional

K952246 - TRI-TECHIN. CUSTOM BLOOD AND/OR URINE TRANSPORT KIT

K952246 is an FDA 510(k) clearance for TRI-TECHIN. CUSTOM BLOOD AND/OR URINE T..., manufactured by Tri-Tech, Inc.. The device is a Class 1 Chemistry device with product code JXA cleared through the Traditional 510(k) pathway after a 39-day FDA review.

K952246 · Tri-Tech, Inc. · Chemistry device
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Jun 1995
Decision
39d
Days
Class 1
Risk

K952246 is an FDA 510(k) clearance for the TRI-TECHIN. CUSTOM BLOOD AND/OR URINE TRANSPORT KIT. Classified as Kit, Screening, Urine (product code JXA), Class I - General Controls.

Submitted by Tri-Tech, Inc. (Southport, US). The FDA issued a Cleared decision on June 20, 1995 after a review of 39 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 866.2660 - the FDA in vitro diagnostics and chemistry 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 - K952246

510(k) Number K952246 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 12, 1995
Decision Date June 20, 1995
Days to Decision 39 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
49d faster than avg
Panel avg: 88d · This submission: 39d
Pathway characteristics
Predicate-based equivalence.

JXA Device Classification - Class 1, General Controls

Product Code JXA Kit, Screening, Urine
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 866.2660
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - JXA Kit, Screening, Urine

All 27
Devices cleared under the same product code (JXA) and FDA review panel - the closest regulatory comparables to K952246.
OSMETECH MICROBIAL ANALYSER-URINARY TRACT INFECTION DETECTOR (OMA-UTI)
K011043 · Osmetech · Nov 2001
URISCREEN
K981084 · Diatech Diagnostics,Inc. · Oct 1998
URINE SCREENING DEVICE
K972676 · Combact Diagnostic Systems , Ltd. · Feb 1998
MULTIPLE (IZON DBS & URINE COLLECTION KIT)
K950257 · Izon Business Products, Inc. · Apr 1995
MULTIPLE (IZON BLOOD & URINE COLLECTION KIT)
K950221 · Izon Business Products, Inc. · Mar 1995
MULTIPLE (IZON URINE COLLECTION KIT)
K950246 · Izon Business Products, Inc. · Mar 1995
K952246 · TRI-TECHIN. CUSTOM BLOOD AND/OR URINE TRANSPORT KIT
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