Cleared Traditional

K090703 - POLY-CHEM 90 GLUCOSE

K090703 is the FDA 510(k) clearance for POLY-CHEM 90 GLUCOSE by Polymedco, Inc.. It is a Class 2 Chemistry device (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

Submission Details

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
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.

Device Classification

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 101
Devices cleared under the same product code (CFR) and FDA review panel - the closest regulatory comparables to K090703.
BS-400 CHEMISTRY ANALYZER, CLC 720 CHEMISTRY ANALYZER
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K101854 · Siemens Healthcare Diagnostics · Mar 2011
COBAS INTEGRA GLUCOSE HK GEN 3 ASSAY
K092603 · Roche Diagnostics · Dec 2009
EASYRA GLU-H REAGENT, MODEL 10200
K092506 · Medica Corp. · Sep 2009
APOLOWAKO HBA1C, GLUCOSE AND ANALYZER, MODELS 993-24601, 991-24401 AND 993-25201
K080123 · Wako Chemicals USA, Inc. · Jul 2008
BS-200 CHEMISTRY ANALYZER, MODE BS-200
K072018 · Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · Feb 2008