Cleared Traditional

K950628 - FIRST CHOICE TEST STRIP

K950628 is an FDA 510(k) clearance for FIRST CHOICE TEST STRIP, manufactured by Polymer Technology Intl.. The device is a Class 2 Chemistry device with product code CGA cleared through the Traditional 510(k) pathway after a 268-day FDA review.

K950628 · Polymer Technology Intl. · Chemistry device
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Nov 1995
Decision
268d
Days
Class 2
Risk

K950628 is an FDA 510(k) clearance for the FIRST CHOICE TEST STRIP. Classified as Glucose Oxidase, Glucose (product code CGA), Class II - Special Controls.

Submitted by Polymer Technology Intl. (Issaquah, US). The FDA issued a Cleared decision on November 8, 1995 after a review of 268 days - an extended review cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1345 - 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. Standard predicate reliance. 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 - K950628

510(k) Number K950628 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 13, 1995
Decision Date November 08, 1995
Days to Decision 268 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
180d slower than avg
Panel avg: 88d · This submission: 268d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

CGA Device Classification - Class 2, Special Controls

Product Code CGA Glucose Oxidase, Glucose
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1345
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 - CGA Glucose Oxidase, Glucose

All 291
Devices cleared under the same product code (CGA) and FDA review panel - the closest regulatory comparables to K950628.
ACCU-CHEK INSTANT PLUS G-C/DM BLOOD GLUCOSE MONITORING SYSTEM
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ACCU-CHEK ALPHA MONITOR & ACCU-CHEK GLUCOSE TEST STRIPS
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EML105 ELECTROLYTE METABOLITE ANALYZER
K952621 · Radiometer America, Inc. · Oct 1995
WAKO AUTOKIT GLUCOSE
K950172 · Wako Chemicals USA, Inc. · Oct 1995
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K951537 · Bayer Corp. · Jul 1995