Cleared Traditional

RAPIDPOINT ACCENT, MODEL 2000, RAPIDPOINT COAG HEPARIN TITRATION TEST, RAPIDPOINT COAG PROTAMINE RESPONSE TEST (K993519) - FDA 510(k) Clearance

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

K993519 · Cardiovascular Diagnostics, Inc. · Hematology device
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Jan 2000
Decision
88d
Days
Class 2
Risk

K993519 is an FDA 510(k) clearance for the RAPIDPOINT ACCENT, MODEL 2000, RAPIDPOINT COAG HEPARIN TITRATION TEST, RAPIDP.... Classified as Analyzer, Heparin, Automated (product code JOX), Class II - Special Controls.

Submitted by Cardiovascular Diagnostics, Inc. (Raleigh, US). The FDA issued a Cleared decision on January 14, 2000 after a review of 88 days - a notably fast clearance cycle.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 864.5680 - 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 Cardiovascular Diagnostics, Inc. devices

Submission Details

510(k) Number K993519 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 18, 1999
Decision Date January 14, 2000
Days to Decision 88 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
25d faster than avg
Panel avg: 113d · This submission: 88d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code JOX Analyzer, Heparin, Automated
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 864.5680
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 - JOX Analyzer, Heparin, Automated

All 14
Devices cleared under the same product code (JOX) and FDA review panel - the closest regulatory comparables to K993519.
HEMOSTASIS MANAGMENT SYSTEM PLUS (HMS-PLUS)
K111339 · Medtronic, Inc. · Jun 2011
HEPARIN DOSE RESPONSE CARTRIDGE
K102953 · Medtronic, Inc. · Nov 2010
HEMOSTASIS MANAGEMENT SYSTEM PLUS (HMS PLUS ), MODEL 305 XX
K101271 · Medtronic, Inc. · Oct 2010
HEPARIN DOSE RESPONSE CONTROLS, MODEL 306-20 POR
K043080 · Medtronic Vascular · Dec 2004
HEPARIN DOSE RESPONSE CARTRIDGE, MODEL 304-20
K042070 · Medtronic Vascular · Oct 2004