Cleared Special

DIAZYME HOMOCYSTEINE ENZYMATIC ASSAY KIT FOR COBAS INTEGRA AND HOMOCYSTEINE CALIBRATOR (K061296) - FDA 510(k) Clearance

Class II Chemistry device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K061296 · Diazyme Laboratories · Chemistry device
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Jun 2006
Decision
35d
Days
Class 2
Risk

K061296 is an FDA 510(k) clearance for the DIAZYME HOMOCYSTEINE ENZYMATIC ASSAY KIT FOR COBAS INTEGRA AND HOMOCYSTEINE C.... Classified as Urinary Homocystine (nonquantitative) Test System (product code LPS), Class II - Special Controls.

Submitted by Diazyme Laboratories (San Diego, US). The FDA issued a Cleared decision on June 13, 2006 after a review of 35 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Diazyme Laboratories devices

Submission Details

510(k) Number K061296 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 09, 2006
Decision Date June 13, 2006
Days to Decision 35 days
Submission Type Special
Review Panel Chemistry (CH)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
53d faster than avg
Panel avg: 88d · This submission: 35d
Pathway characteristics
Modification to existing cleared device.

Device Classification

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 8
Devices cleared under the same product code (LPS) and FDA review panel - the closest regulatory comparables to K061296.
DIMENSION VISTA HCYS FLEX REAGENT CARTRIDGE
K063206 · Dade Behring, Inc. · Dec 2006
HEMOSIL HOMOCYSTEINE AND CONTROLS
K061598 · Instrumentation Laboratory CO · Sep 2006
VITROS CHEMISTRY PRODUCTS HCY REAGENT, VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 27, HCY PERFORMANCE VERIFIERS
K061588 · Ortho-Clinical Diagnostics, Inc. · Jul 2006
N LATEX HCY, N PROTEIN STANDARD SL, N/T PROTEIN CONTROL L/M/H
K052788 · Dade Behring, Inc. · Mar 2006
IMMULITE HOMOCYSTEINE MODEL LKHO1 / IMMULITE 2000 HOMOCYSTEINE MODEL L2KHO2
K003597 · Diagnostic Products Corp. · Feb 2001
BIO-RAD HOMOCYSTEINE BY HPLC
K993107 · Bio-Rad · Dec 1999