Cleared Special

K042423 - VERIFYNOW-ASPIRIN ASSAY

K042423 is the FDA 510(k) clearance for VERIFYNOW-ASPIRIN ASSAY by Accumetrics, Inc.. It is a Class 2 Hematology device (product code JOZ) cleared through the Special 510(k) pathway after a 29-day FDA review.

K042423 · Accumetrics, Inc. · Hematology device
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Oct 2004
Decision
29d
Days
Class 2
Risk

K042423 is an FDA 510(k) clearance for the VERIFYNOW-ASPIRIN ASSAY. Classified as System, Automated Platelet Aggregation (product code JOZ), Class II - Special Controls.

Submitted by Accumetrics, Inc. (San Diego, US). The FDA issued a Cleared decision on October 6, 2004 after a review of 29 days - a notably fast clearance cycle.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 864.5700 - the FDA hematology device 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 Accumetrics, Inc. devices

Submission Details

510(k) Number K042423 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 07, 2004
Decision Date October 06, 2004
Days to Decision 29 days
Submission Type Special
Review Panel Hematology (HE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
84d faster than avg
Panel avg: 113d · This submission: 29d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code JOZ System, Automated Platelet Aggregation
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 864.5700
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 Hematology devices follow this clearance model.

Regulatory Peers - JOZ System, Automated Platelet Aggregation

All 13
Devices cleared under the same product code (JOZ) and FDA review panel - the closest regulatory comparables to K042423.
T-TAS 01 Total Thrombus-formation Analysis System Instrument, PL Chip for T-TAS 01, PL Chip Reservoir Set for T-TAS 01, BAPA tube for T-TAS 01
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K023761 · Helena Laboratories · Feb 2003
PLATELETWORKS
K012723 · Helena Laboratories · Sep 2001
DADE PFA-100 PLATELET FUNCTION ANALYZER MODEL-100, DADE PFA COLLEGEN/EPINEPHRINE TEST CARTRIDE, DADE PFA COLLEAGEN /ADP
K002885 · Dade Behring, Inc. · Jun 2001