Cleared Traditional

K033706 - POLYMEDCO HOMOCYSTEINE TEST FOR THE POLY-CHEM AND HITACHI CHEMISTRY SYSTEMS

K033706 is an FDA 510(k) clearance for POLYMEDCO HOMOCYSTEINE TEST FOR THE POL..., manufactured by Polymedco, Inc.. The device is a Class 2 Chemistry device with product code LPS cleared through the Traditional 510(k) pathway after a 70-day FDA review.

K033706 · Polymedco, Inc. · Chemistry device
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Feb 2004
Decision
70d
Days
Class 2
Risk

K033706 is an FDA 510(k) clearance for the POLYMEDCO HOMOCYSTEINE TEST FOR THE POLY-CHEM AND HITACHI CHEMISTRY SYSTEMS. Classified as Urinary Homocystine (nonquantitative) Test System (product code LPS), Class II - Special Controls.

Submitted by Polymedco, Inc. (Cortlandt Manor, US). The FDA issued a Cleared decision on February 4, 2004 after a review of 70 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1377 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Polymedco, Inc. devices

FDA 510(k) Submission Details - K033706

510(k) Number K033706 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 26, 2003
Decision Date February 04, 2004
Days to Decision 70 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
18d faster than avg
Panel avg: 88d · This submission: 70d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LPS Device Classification - Class 2, Special Controls

Product Code LPS Urinary Homocystine (nonquantitative) Test System
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1377
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 - LPS Urinary Homocystine (nonquantitative) Test System

All 24
Devices cleared under the same product code (LPS) and FDA review panel - the closest regulatory comparables to K033706.
VITROS CHEMISTRY PRODUCTS HCY REAGENT, VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 27, HCY PERFORMANCE VERIFIERS
K061588 · Ortho-Clinical Diagnostics, Inc. · Jul 2006
DIAZYME HOMOCYSTEINE ENZYMATIC ASSAY KIT FOR COBAS INTEGRA AND HOMOCYSTEINE CALIBRATOR
K061296 · Diazyme Laboratories · Jun 2006
N LATEX HCY, N PROTEIN STANDARD SL, N/T PROTEIN CONTROL L/M/H
K052788 · Dade Behring, Inc. · Mar 2006
HOMOCYSTEINE MICROTITER PLATE ASSAY
K032012 · Diazyme Laboratories · Sep 2003
ACS 180 HOMOCYSTEINE ASSAY
K013606 · Bayer Diagnostics Corp. · Dec 2001
ADVIA CENTAUR HOMOCYSTEINE ASSAY
K013406 · Bayer Diagnostics Corp. · Dec 2001