Cleared Traditional

K090703 - POLY-CHEM 90 GLUCOSE

K090703 is an FDA 510(k) clearance for POLY-CHEM 90 GLUCOSE, manufactured by Polymedco, Inc.. The device is a Class 2 Chemistry device with product code CFR cleared through the Traditional 510(k) pathway after a 217-day FDA review.

K090703 · Polymedco, Inc. · Chemistry device
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Oct 2009
Decision
217d
Days
Class 2
Risk

K090703 is an FDA 510(k) clearance for the POLY-CHEM 90 GLUCOSE. Classified as Hexokinase, Glucose (product code CFR), Class II - Special Controls.

Submitted by Polymedco, Inc. (Cortlandt Manor, US). The FDA issued a Cleared decision on October 20, 2009 after a review of 217 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 Polymedco, Inc. devices

FDA 510(k) Submission Details - K090703

510(k) Number K090703 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 17, 2009
Decision Date October 20, 2009
Days to Decision 217 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
129d slower than avg
Panel avg: 88d · This submission: 217d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

CFR Device Classification - Class 2, Special Controls

Product Code CFR Hexokinase, 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 - CFR Hexokinase, Glucose

All 134
Devices cleared under the same product code (CFR) and FDA review panel - the closest regulatory comparables to K090703.
PENTRA C200, ISE MODULE AND ABX PENTRA GLUCOSE HK CP REAGENT
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K092506 · Medica Corp. · Sep 2009
ABX PENTRA GLUCOSE HK CP, ABX PENTRA URIC ACID CP, ABX PENTRA URINE CONTROL L/H
K081276 · Horiba Abx · Sep 2008
APOLOWAKO HBA1C, GLUCOSE AND ANALYZER, MODELS 993-24601, 991-24401 AND 993-25201
K080123 · Wako Chemicals USA, Inc. · Jul 2008