Cleared Traditional

K030650 - STONEGUARD II REAGENT STRIPS FOR URINALYSIS AND CONFIRM CONTROL SOLUTIONS

K030650 is an FDA 510(k) clearance for STONEGUARD II REAGENT STRIPS FOR URINAL..., manufactured by Uridynamics, Inc.. The device is a Class 1 Chemistry device with product code CEN cleared through the Traditional 510(k) pathway after a 45-day FDA review.

K030650 · Uridynamics, Inc. · Chemistry device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Apr 2003
Decision
45d
Days
Class 1
Risk

K030650 is an FDA 510(k) clearance for the STONEGUARD II REAGENT STRIPS FOR URINALYSIS AND CONFIRM CONTROL SOLUTIONS. Classified as Dye-indicator, Ph (urinary, Non-quantitative) (product code CEN), Class I - General Controls.

Submitted by Uridynamics, Inc. (Indianapolis, US). The FDA issued a Cleared decision on April 14, 2003 after a review of 45 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1550 - 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 - K030650

510(k) Number K030650 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 28, 2003
Decision Date April 14, 2003
Days to Decision 45 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
44d faster than avg
Panel avg: 89d · This submission: 45d
Pathway characteristics
Predicate-based equivalence.

CEN Device Classification - Class 1, General Controls

Product Code CEN Dye-indicator, Ph (urinary, Non-quantitative)
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.1550
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 - CEN Dye-indicator, Ph (urinary, Non-quantitative)

All 10
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K030650 · STONEGUARD II REAGENT STRIPS FOR URINALYSIS AND CONFIRM CONTROL SOLUTIONS
Download PDF FDA Summary Uridynamics, Inc.