Cleared Traditional

K950246 - MULTIPLE (IZON URINE COLLECTION KIT)

K950246 is an FDA 510(k) clearance for MULTIPLE (IZON URINE COLLECTION KIT), manufactured by Izon Business Products, Inc.. The device is a Class 1 Chemistry device with product code JXA cleared through the Traditional 510(k) pathway after a 60-day FDA review.

K950246 · Izon Business Products, Inc. · Chemistry device
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Mar 1995
Decision
60d
Days
Class 1
Risk

K950246 is an FDA 510(k) clearance for the MULTIPLE (IZON URINE COLLECTION KIT). Classified as Kit, Screening, Urine (product code JXA), Class I - General Controls.

Submitted by Izon Business Products, Inc. (West Nyack, US). The FDA issued a Cleared decision on March 21, 1995 after a review of 60 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 - K950246

510(k) Number K950246 FDA.gov
FDA Decision Cleared Substantially Equivalent - Special 510(k) (SESK)
Date Received January 20, 1995
Decision Date March 21, 1995
Days to Decision 60 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
29d faster than avg
Panel avg: 89d · This submission: 60d
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 39
Devices cleared under the same product code (JXA) and FDA review panel - the closest regulatory comparables to K950246.
TRI-TECHIN. CUSTOM BLOOD AND/OR URINE TRANSPORT KIT
K952246 · Tri-Tech, Inc. · Jun 1995
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
CULTURIA MACCONKEY-MUG
K934759 · Clinical Convenience Products, Inc. · Sep 1994
BAC-T-SCREEN
K924218 · Biomerieux Vitek, Inc. · Feb 1993
DIASLIDE URINE CULTURING DEVICE
K921045 · Savyon Diagnostics , Ltd. · Sep 1992
K950246 · MULTIPLE (IZON URINE COLLECTION KIT)
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