Cleared Traditional

K061944 - POLY-CHEM CREATININE

K061944 is an FDA 510(k) clearance for POLY-CHEM CREATININE, manufactured by Polymedco, Inc.. The device is a Class 2 Chemistry device with product code JFY cleared through the Traditional 510(k) pathway after a 116-day FDA review.

K061944 · Polymedco, Inc. · Chemistry device
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Nov 2006
Decision
116d
Days
Class 2
Risk

K061944 is an FDA 510(k) clearance for the POLY-CHEM CREATININE. Classified as Enzymatic Method, Creatinine (product code JFY), Class II - Special Controls.

Submitted by Polymedco, Inc. (Cortlandt Manor, US). The FDA issued a Cleared decision on November 3, 2006 after a review of 116 days - within the typical 510(k) review window.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1225 - 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 - K061944

510(k) Number K061944 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 10, 2006
Decision Date November 03, 2006
Days to Decision 116 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
28d slower than avg
Panel avg: 88d · This submission: 116d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JFY Device Classification - Class 2, Special Controls

Product Code JFY Enzymatic Method, Creatinine
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1225
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 - JFY Enzymatic Method, Creatinine

All 39
Devices cleared under the same product code (JFY) and FDA review panel - the closest regulatory comparables to K061944.
DIAZYME CREATININE LIQUID REAGENTS ASSAY
K062105 · Diazyme Laboratories · Apr 2007
WAKO L-TYPE CREATININE-M TEST, AND WAKO CREATININE CALIBRATOR
K061775 · Wako Chemicals USA, Inc. · Feb 2007
VITROS CHEMISTRY PRODUCTS CREA SLIDES,MODEL# 6802584, VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 1,MODEL#1882208
K063591 · Ortho-Clinical Diagnostics, Inc. · Dec 2006
CREATININE LIQUICOLOR
K050283 · Stanbio Laboratory · Jun 2005
COBAS INTEGRA CREATININE PLUS VER.2 ASSAY
K024098 · Roche Diagnostics Corp. · Dec 2002
CLINITEK ATLAS PRO 12 REAGENT PAK SYSTEM
K021428 · Bayer Corp. · Jul 2002