Cleared Traditional

K013596 - MODIFICATION TO ULTEGRA SYSTEM RAPID PLATELET FUNCTION ASSAY - TRAP (RPFA-TRAP)

K013596 is an FDA 510(k) clearance for MODIFICATION TO ULTEGRA SYSTEM RAPID PL..., 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 197-day FDA review.

K013596 · Accumetrics, Inc. · Hematology device
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Optimized for regulatory review, auditing and printing
May 2002
Decision
197d
Days
Class 2
Risk

K013596 is an FDA 510(k) clearance for the MODIFICATION TO ULTEGRA SYSTEM RAPID PLATELET FUNCTION ASSAY - TRAP (RPFA-TRAP). 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 May 16, 2002 after a review of 197 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Hematology review framework, consistent with the majority of Class II 510(k) submissions.

View all Accumetrics, Inc. devices

FDA 510(k) Submission Details - K013596

510(k) Number K013596 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 31, 2001
Decision Date May 16, 2002
Days to Decision 197 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
84d slower than avg
Panel avg: 113d · This submission: 197d
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 31
Devices cleared under the same product code (JOZ) and FDA review panel - the closest regulatory comparables to K013596.
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
PLATELETWORKS, MODELS PW-A, PW-C
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
ULTEGRA SYSTEM ANALYZER, ULTEGRA SYSTEM RPFA-TRAP TEST CARTIDGES, ULTEGRA SYSTEM RPFA-TRAP LEVEL ONE QC, ULTEGRA SYSTEM
K992531 · Accumetrics, Inc. · Dec 1999