Cleared Special

K062234 - MODIFICATION TO DIADEXUS PLAC TEST

K062234 is an FDA 510(k) clearance for MODIFICATION TO DIADEXUS PLAC TEST, manufactured by Diadexus, Inc.. The device is a Class 2 Chemistry device with product code NOE cleared through the Special 510(k) pathway after a 40-day FDA review.

K062234 · Diadexus, Inc. · Chemistry device
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Sep 2006
Decision
40d
Days
Class 2
Risk

K062234 is an FDA 510(k) clearance for the MODIFICATION TO DIADEXUS PLAC TEST. Classified as Test, System, Immunoassay, Lipoprotein-associated Phospholipase A2 (product code NOE), Class II - Special Controls.

Submitted by Diadexus, Inc. (South San Francisco, US). The FDA issued a Cleared decision on September 11, 2006 after a review of 40 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 866.5600 - 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 Diadexus, Inc. devices

FDA 510(k) Submission Details - K062234

510(k) Number K062234 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 02, 2006
Decision Date September 11, 2006
Days to Decision 40 days
Submission Type Special
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
48d faster than avg
Panel avg: 88d · This submission: 40d
Pathway characteristics
Modification to existing cleared device.

NOE Device Classification - Class 2, Special Controls

Product Code NOE Test, System, Immunoassay, Lipoprotein-associated Phospholipase A2
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.5600
Definition The Lipoprotein-associated Phospholipase A2, Immunoassay, System, Test, Is Intended To Measure Lipoprotein-associated Phospholipase A2 In Human Plasma In Conjunction With Clinical Evaluation And Other Patient Risk Factors Including Biochemical Analyses As An Aid In Predicting Risk For Coronary Heat Disease. This Device Differs From The Classification Regulation In That It Is A Different Analyte, Thus A New Marker For Predicting Risk Of Coronary Heart Disease. This Device Is Measuring An Enzyme That Is Produced By Macrophages Where As The Regulation Is For The Measurement Of A Lipoprotein.
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 - NOE Test, System, Immunoassay, Lipoprotein-associated Phospholipase A2

Devices cleared under the same product code (NOE) and FDA review panel - the closest regulatory comparables to K062234.
Diazyme PLAC® Test for Lp-PLA2 Activity
K203136 · Diazyme Laboratories, Inc. · Aug 2021
PLAC TEST FOR LP-PLA2 ACTIVITY
K141575 · Diadexus, Inc. · Dec 2014
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K072599 · Diadexus, Inc. · Dec 2007
DIADEXUS PLAC TEST
K050523 · Diadexus, Inc. · Jun 2005