Cleared Traditional

K953662 - FIRST CHOICE KETONES URINE TEST STRIPS

K953662 is an FDA 510(k) clearance for FIRST CHOICE KETONES URINE TEST STRIPS, manufactured by Polymer Technology Intl.. The device is a Class 1 Chemistry device with product code JIN cleared through the Traditional 510(k) pathway after a 312-day FDA review.

K953662 · Polymer Technology Intl. · Chemistry device
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Jun 1996
Decision
312d
Days
Class 1
Risk

K953662 is an FDA 510(k) clearance for the FIRST CHOICE KETONES URINE TEST STRIPS. Classified as Nitroprusside, Ketones (urinary, Non-quant.) (product code JIN), Class I - General 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 862.1435 - 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 - K953662

510(k) Number K953662 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.

JIN Device Classification - Class 1, General Controls

Product Code JIN Nitroprusside, Ketones (urinary, Non-quant.)
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.1435
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 - JIN Nitroprusside, Ketones (urinary, Non-quant.)

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