Cleared Traditional

THROMBELASTOGRAPH (TEG) PLATELET MAPPING ASSAY (K041502) - FDA 510(k) Clearance

Class II Hematology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

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

Submission Details

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
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.

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 37
Devices cleared under the same product code (JOZ) and FDA review panel - the closest regulatory comparables to K041502.
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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PLATELETWORKS
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DADE PFA-100 PLATELET FUNCTION ANALYZER MODEL-100, DADE PFA COLLEGEN/EPINEPHRINE TEST CARTRIDE, DADE PFA COLLEAGEN /ADP
K002885 · Dade Behring, Inc. · Jun 2001