Cleared Special

K050513 - MDA B.30

K050513 is the FDA 510(k) clearance for MDA B.30 by bioMerieux, Inc.. It is a Class 2 Hematology device (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)
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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.

View all bioMerieux, Inc. devices

Submission Details

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.

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 116
Devices cleared under the same product code (JPA) and FDA review panel - the closest regulatory comparables to K050513.
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K040359 · Instrumentation Laboratory CO · Mar 2004
HEMOCHRON RESPONSE/SYSTEM
K030818 · International Technidyne Corp. · Apr 2003