Cleared Traditional

K993519 - RAPIDPOINT ACCENT, MODEL 2000, RAPIDPOINT COAG HEPARIN TITRATION TEST, RAPIDPOINT COAG PROTAMINE RESPONSE TEST

K993519 is an FDA 510(k) clearance for RAPIDPOINT ACCENT, manufactured by Cardiovascular Diagnostics, Inc.. The device is a Class 2 Hematology device with product code JOX cleared through the Traditional 510(k) pathway after a 88-day FDA review.

K993519 · Cardiovascular Diagnostics, Inc. · Hematology device
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Optimized for regulatory review, auditing and printing
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

FDA 510(k) Submission Details - K993519

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
Combination Product No
PCCP Authorized No
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.

JOX Device Classification - Class 2, Special Controls

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 7
Devices cleared under the same product code (JOX) and FDA review panel - the closest regulatory comparables to K993519.
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HEPAQUANT
K813011 · Streck Laboratories, Inc. · Jan 1982