Cleared Traditional

RAPIDTEG TEG-ACT TEST (K062604) - FDA 510(k) Clearance

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

K062604 · Haemoscope Corp. · Hematology device
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Jan 2007
Decision
152d
Days
Class 2
Risk

K062604 is an FDA 510(k) clearance for the RAPIDTEG TEG-ACT TEST. Classified as Activated Whole Blood Clotting Time (product code JBP), Class II - Special Controls.

Submitted by Haemoscope Corp. (Niles, US). The FDA issued a Cleared decision on January 31, 2007 after a review of 152 days - an extended review cycle.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 864.7140 - 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 Haemoscope Corp. devices

Submission Details

510(k) Number K062604 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 01, 2006
Decision Date January 31, 2007
Days to Decision 152 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
39d slower than avg
Panel avg: 113d · This submission: 152d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code JBP Activated Whole Blood Clotting Time
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 864.7140
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 - JBP Activated Whole Blood Clotting Time

All 23
Devices cleared under the same product code (JBP) and FDA review panel - the closest regulatory comparables to K062604.
Sonoclot Coagulation & Platelet Function Analyzer System with Sonoclot Viewer
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ACTALYKE XL ACTIVATED CLOTTING TIME ANALYZER, MODEL 5770
K020914 · Helena Laboratories · May 2002
ACTALYKE MINI ACTIVATED CLOTTING TIME TEST SYSTEM, MODEL 5750/5752
K013078 · Helena Laboratories · Jan 2002
ACT TEST CATRIDGES FOR COAGUCHEK PRO SYSTEM, ACT CONTROLS FOR COAGUCHEK PRO SYSTEM
K992851 · Roche Diagnostics Corp. · Jan 2000