Cleared Traditional

K051231 - VERIFYNOW-P2Y12 ASSAY

K051231 is an FDA 510(k) clearance for VERIFYNOW-P2Y12 ASSAY, manufactured by Accumetrics, Inc.. The device is a Class 2 Hematology device with product code JOZ cleared through the Traditional 510(k) pathway after a 84-day FDA review.

K051231 · Accumetrics, Inc. · Hematology device
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Aug 2005
Decision
84d
Days
Class 2
Risk

K051231 is an FDA 510(k) clearance for the VERIFYNOW-P2Y12 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 August 5, 2005 after a review of 84 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. 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 Accumetrics, Inc. devices

FDA 510(k) Submission Details - K051231

510(k) Number K051231 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 13, 2005
Decision Date August 05, 2005
Days to Decision 84 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
29d faster than avg
Panel avg: 113d · This submission: 84d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JOZ Device Classification - Class 2, Special Controls

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 30
Devices cleared under the same product code (JOZ) and FDA review panel - the closest regulatory comparables to K051231.
MULTIPLATE 5.0 AGGREGOMETER
K103555 · Verum Diagnostica GmbH · Jul 2012
DADE PFA-100 PLATELET FUNCTION ANALYZER AND REAGENTS
K060489 · Dade Behring, Inc. · Jul 2006
CHRONO-LOG WHOLE BLOOD LUMI-AGGREGOMETER, MODEL 700
K050265 · Chrono-Log Corp. · Oct 2005
VERIFYNOW-ASPIRIN ASSAY
K042423 · Accumetrics, Inc. · Oct 2004
THROMBELASTOGRAPH (TEG) PLATELET MAPPING ASSAY
K041502 · Haemoscope Corp. · Sep 2004
CHRONO-LOG WHOLE BLOOD AGGREGOMETER, MODELS 591A AND 592A
K032951 · Chrono-Log Corp. · Apr 2004