Cleared Traditional

K953661 - FIRST CHOICE GLUCOSE URINE TEST STRIPS

K953661 is an FDA 510(k) clearance for FIRST CHOICE GLUCOSE URINE TEST STRIPS, manufactured by Polymer Technology Intl.. The device is a Class 2 Chemistry device with product code JIL cleared through the Traditional 510(k) pathway after a 312-day FDA review.

K953661 · Polymer Technology Intl. · Chemistry device
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Jun 1996
Decision
312d
Days
Class 2
Risk

K953661 is an FDA 510(k) clearance for the FIRST CHOICE GLUCOSE URINE TEST STRIPS. Classified as Method, Enzymatic, Glucose (urinary, Non-quantitative) (product code JIL), Class II - Special Controls.

Submitted by Polymer Technology Intl. (Issaquah, US). The FDA issued a Cleared decision on June 14, 1996 after a review of 312 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1340 - 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 - K953661

510(k) Number K953661 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 07, 1995
Decision Date June 14, 1996
Days to Decision 312 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
224d slower than avg
Panel avg: 88d · This submission: 312d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JIL Device Classification - Class 2, Special Controls

Product Code JIL Method, Enzymatic, Glucose (urinary, Non-quantitative)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1340
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 Chemistry devices follow this clearance model.

Regulatory Peers - JIL Method, Enzymatic, Glucose (urinary, Non-quantitative)

All 45
Devices cleared under the same product code (JIL) and FDA review panel - the closest regulatory comparables to K953661.
CLINISTRIP
K970250 · Teco Diagnostics · Apr 1997
HEALTH CHECK URI-TEST GLUCOSE IN URINE TEST
K954968 · Tcpi, Inc. · Jul 1996
DIA SCREEN 10 WAY REAGENT STRIPS
K961375 · Genesis Labs, Inc. · Jun 1996
IN VITRO DIAGNOSTIC URINE REAGENT STRIPS SET
K942648 · Teco Diagnostics · Mar 1995
URINE REAGENT STRIP-3 PARAMETERS
K940469 · Teco Diagnostics · Sep 1994
CHEMSTRIP(R) 10 WITH SG URINE TEST STRIPS
K896454 · Boehringer Mannheim Corp. · Jan 1990