Cleared Special

K002528 - SONOCLOT COAGULATION & PLATELET FUNCTIO...

K002528 is an FDA 510(k) clearance for SONOCLOT COAGULATION & PLATELET FUNCTIO..., manufactured by Sienco, Inc.. The device is a Class 2 Hematology device with product code JBP cleared through the Special 510(k) pathway after a 15-day FDA review.

K002528 · Sienco, Inc. · Hematology device
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Aug 2000
Decision
15d
Days
Class 2
Risk

K002528 is an FDA 510(k) clearance for the SONOCLOT COAGULATION & PLATELET FUNCTION ANALYZER SYSTEM WITH SIGNATURE VIEWE.... Classified as Activated Whole Blood Clotting Time (product code JBP), Class II - Special Controls.

Submitted by Sienco, Inc. (Boulder, US). The FDA issued a Cleared decision on August 31, 2000 after a review of 15 days - a notably fast clearance cycle.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 864.7140 - the FDA hematology device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Sienco, Inc. devices

FDA 510(k) Submission Details - K002528

510(k) Number K002528 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 16, 2000
Decision Date August 31, 2000
Days to Decision 15 days
Submission Type Special
Review Panel Hematology (HE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
98d faster than avg
Panel avg: 113d · This submission: 15d
Pathway characteristics
Modification to existing cleared device.

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 9
Devices cleared under the same product code (JBP) and FDA review panel - the closest regulatory comparables to K002528.
Sonoclot Coagulation & Platelet Function Analyzer System with Sonoclot Viewer
K223635 · Sienco, Inc. · Jan 2023
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
HEMOCHRON JR. MICROCOAGULATION LOW RANGE ACT
K960749 · International Technidyne Corp. · Aug 1996
CATALOG NO. J-ACT+ & QC-ACT+
K941007 · International Technidyne Corp. · Jun 1994