Cleared Traditional

K041502 - THROMBELASTOGRAPH (TEG) PLATELET MAPPING ASSAY

K041502 is an FDA 510(k) clearance for THROMBELASTOGRAPH (TEG) PLATELET MAPPIN..., manufactured by Haemoscope Corp.. The device is a Class 2 Hematology device with product code JOZ cleared through the Traditional 510(k) pathway after a 86-day FDA review.

K041502 · Haemoscope Corp. · Hematology device
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Sep 2004
Decision
86d
Days
Class 2
Risk

K041502 is an FDA 510(k) clearance for the THROMBELASTOGRAPH (TEG) PLATELET MAPPING ASSAY. Classified as System, Automated Platelet Aggregation (product code JOZ), Class II - Special Controls.

Submitted by Haemoscope Corp. (Niles, US). The FDA issued a Cleared decision on September 1, 2004 after a review of 86 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 Haemoscope Corp. devices

FDA 510(k) Submission Details - K041502

510(k) Number K041502 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 07, 2004
Decision Date September 01, 2004
Days to Decision 86 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
27d faster than avg
Panel avg: 113d · This submission: 86d
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 K041502.
CHRONO-LOG WHOLE BLOOD LUMI-AGGREGOMETER, MODEL 700
K050265 · Chrono-Log Corp. · Oct 2005
VERIFYNOW-P2Y12 ASSAY
K051231 · Accumetrics, Inc. · Aug 2005
VERIFYNOW-ASPIRIN ASSAY
K042423 · Accumetrics, Inc. · Oct 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