Cleared Traditional

K020852 - POLY-CHEM GLUCOSE

K020852 is an FDA 510(k) clearance for POLY-CHEM 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 110-day FDA review.

K020852 · Polymedco, Inc. · Chemistry device
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Jul 2002
Decision
110d
Days
Class 2
Risk

K020852 is an FDA 510(k) clearance for the POLY-CHEM 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 July 3, 2002 after a review of 110 days - within the typical 510(k) review window.

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 - K020852

510(k) Number K020852 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 15, 2002
Decision Date July 03, 2002
Days to Decision 110 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
22d slower than avg
Panel avg: 88d · This submission: 110d
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 K020852.
GLUCOSE FLEX REAGENT CARTRIDGE (GLUC)
K031135 · Dade Behring, Inc. · Jun 2003
WAKO L-TYPE GLUCOSE 2
K024281 · Wako Chemicals USA, Inc. · Feb 2003
GLUCOSE-SL-C ASSAY, MODEL 257-30
K023739 · Diagnostic Chemicals , Ltd. · Jan 2003
ADVIA 1650 GLUCOSE HEXOKINASE 11 ASSAY
K011963 · Bayer Corp. · Nov 2001
RAICHEM GLUCOSE UV REAGENT
K012668 · Hemagen Diagnostics, Inc. · Oct 2001
GLUCOSE (HEXOKINASE)
K011900 · Jas Diagnostics, Inc. · Jul 2001