Cleared Traditional

K062604 - RAPIDTEG TEG-ACT TEST

K062604 is an FDA 510(k) clearance for RAPIDTEG TEG-ACT TEST, manufactured by Haemoscope Corp.. The device is a Class 2 Hematology device with product code JBP cleared through the Traditional 510(k) pathway after a 152-day FDA review.

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

FDA 510(k) Submission Details - K062604

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.

JBP Device Classification - Class 2, Special Controls

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 15
Devices cleared under the same product code (JBP) and FDA review panel - the closest regulatory comparables to K062604.
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(TAS) LOW RANGE HEPARIN MANAGEMENT CARD RAPIDPOINT
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I-STAT SYSTEM
K992571 · I-Stat Corp. · Feb 2000
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K992851 · Roche Diagnostics Corp. · Jan 2000