Cleared Traditional

K953672 - FIRST CHOICE URINARY TRACT INFECTION TEST STRIPS

K953672 is an FDA 510(k) clearance for FIRST CHOICE URINARY TRACT INFECTION TE..., manufactured by Polymer Technology Intl.. The device is a Class 1 Chemistry device with product code JMT cleared through the Traditional 510(k) pathway after a 329-day FDA review.

K953672 · Polymer Technology Intl. · Chemistry device
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Jul 1996
Decision
329d
Days
Class 1
Risk

K953672 is an FDA 510(k) clearance for the FIRST CHOICE URINARY TRACT INFECTION TEST STRIPS. Classified as Diazo (colorimetric), Nitrite (urinary, Non-quant) (product code JMT), Class I - General Controls.

Submitted by Polymer Technology Intl. (Issaquah, US). The FDA issued a Cleared decision on July 1, 1996 after a review of 329 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1510 - 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: Standard predicate-based submission. Elevated predicate reliance profile. This clearance follows a standard predicate-based equivalence path within the Chemistry review framework, consistent with the majority of Class II 510(k) submissions.

View all Polymer Technology Intl. devices

FDA 510(k) Submission Details - K953672

510(k) Number K953672 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 07, 1995
Decision Date July 01, 1996
Days to Decision 329 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
241d slower than avg
Panel avg: 88d · This submission: 329d
Pathway characteristics
Predicate-based equivalence.

JMT Device Classification - Class 1, General Controls

Product Code JMT Diazo (colorimetric), Nitrite (urinary, Non-quant)
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.1510
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.