Cleared Special

K050513 - MDA B.30

K050513 is an FDA 510(k) clearance for MDA B.30, manufactured by bioMerieux, Inc.. The device is a Class 2 Hematology device with product code JPA cleared through the Special 510(k) pathway after a 31-day FDA review.

K050513 · bioMerieux, Inc. · Hematology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Apr 2005
Decision
31d
Days
Class 2
Risk

K050513 is an FDA 510(k) clearance for the MDA B.30. Classified as System, Multipurpose For In Vitro Coagulation Studies (product code JPA), Class II - Special Controls.

Submitted by bioMerieux, Inc. (Durham, US). The FDA issued a Cleared decision on April 1, 2005 after a review of 31 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 - K050513

510(k) Number K050513 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 01, 2005
Decision Date April 01, 2005
Days to Decision 31 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
82d faster than avg
Panel avg: 113d · This submission: 31d
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
Devices cleared under the same product code (JPA) and FDA review panel - the closest regulatory comparables to K050513.
COAG-A-MATE MTX III
K051030 · bioMerieux, Inc. · Dec 2005
HEMORAM/AGGRAM ANALYZER
K050053 · Helena Laboratories · Jul 2005
IMMEDIA PROTHROMBIN TIME SYSTEM
K050243 · Farallon Medial, Inc. · Jun 2005
HEMOCHRON SIGNATURE ELITE
K050016 · International Technidyne Corp. · Feb 2005
HEMOSIL SPECIAL TEST CONTROLS LEVEL 1 & 2
K040359 · Instrumentation Laboratory CO · Mar 2004
POTENS +
K033137 · Wada, Inc. · Dec 2003
K050513 · MDA B.30
Download PDF FDA Summary bioMerieux, Inc.