Cleared Special

K093001 - STA-R EVOLUTION EXPERT SERIES HEMOSTASI...

K093001 is the FDA 510(k) clearance for STA-R EVOLUTION EXPERT SERIES HEMOSTASI... by Diagnostica Stago, Incorporated. It is a Class 2 Hematology device (product code JPA) cleared through the Special 510(k) pathway after a 81-day FDA review.

K093001 · Diagnostica Stago, Incorporated · Hematology device
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Dec 2009
Decision
81d
Days
Class 2
Risk

K093001 is an FDA 510(k) clearance for the STA-R EVOLUTION EXPERT SERIES HEMOSTASIS SYSTEM AUTOMATED MULTI-PARAMETRIC AN.... Classified as System, Multipurpose For In Vitro Coagulation Studies (product code JPA), Class II - Special Controls.

Submitted by Diagnostica Stago, Incorporated (Parisppany, US). The FDA issued a Cleared decision on December 18, 2009 after a review of 81 days - a notably fast clearance cycle.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 864.5425 - 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 Diagnostica Stago, Incorporated devices

Submission Details

510(k) Number K093001 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 28, 2009
Decision Date December 18, 2009
Days to Decision 81 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
32d faster than avg
Panel avg: 113d · This submission: 81d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code JPA System, Multipurpose For In Vitro Coagulation Studies
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 864.5425
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 - JPA System, Multipurpose For In Vitro Coagulation Studies

All 117
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