Cleared Special

K093167 - STA COMPACT AUTOMATED MULTI-PARAMETRIC ANALYZER

K093167 is an FDA 510(k) clearance for STA COMPACT AUTOMATED MULTI-PARAMETRIC ..., manufactured by Diagnostica Stago, Inc.. The device is a Class 2 Hematology device with product code JPA cleared through the Special 510(k) pathway after a 76-day FDA review.

K093167 · Diagnostica Stago, Inc. · Hematology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Dec 2009
Decision
76d
Days
Class 2
Risk

K093167 is an FDA 510(k) clearance for the STA COMPACT AUTOMATED MULTI-PARAMETRIC ANALYZER. Classified as System, Multipurpose For In Vitro Coagulation Studies (product code JPA), Class II - Special Controls.

Submitted by Diagnostica Stago, Inc. (Parisppany, US). The FDA issued a Cleared decision on December 22, 2009 after a review of 76 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.

FDA 510(k) Submission Details - K093167

510(k) Number K093167 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 07, 2009
Decision Date December 22, 2009
Days to Decision 76 days
Submission Type Special
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
37d faster than avg
Panel avg: 113d · This submission: 76d
Pathway characteristics
Modification to existing cleared device.

JPA Device Classification - Class 2, Special Controls

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 181
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Download PDF FDA Summary Diagnostica Stago, In…