Cleared Special

K061511 - R&D CBC-3D + CRP HEMATOLOGY CONTROL

K061511 is an FDA 510(k) clearance for R&D CBC-3D + CRP HEMATOLOGY CONTROL, manufactured by R&D Systems, Inc.. The device is a Class 2 Hematology device with product code JPK cleared through the Special 510(k) pathway after a 39-day FDA review.

K061511 · R&D Systems, Inc. · Hematology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jul 2006
Decision
39d
Days
Class 2
Risk

K061511 is an FDA 510(k) clearance for the R&D CBC-3D + CRP HEMATOLOGY CONTROL. Classified as Mixture, Hematology Quality Control (product code JPK), Class II - Special Controls.

Submitted by R&D Systems, Inc. (Minneapolis, US). The FDA issued a Cleared decision on July 10, 2006 after a review of 39 days - a notably fast clearance cycle.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 864.8625 - 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 - K061511

510(k) Number K061511 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 01, 2006
Decision Date July 10, 2006
Days to Decision 39 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
74d faster than avg
Panel avg: 113d · This submission: 39d
Pathway characteristics
Modification to existing cleared device.

JPK Device Classification - Class 2, Special Controls

Product Code JPK Mixture, Hematology Quality Control
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 864.8625
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 - JPK Mixture, Hematology Quality Control

All 188
Devices cleared under the same product code (JPK) and FDA review panel - the closest regulatory comparables to K061511.
CBC-5D PLUS RETICS HEMATOLOGY CONTROL, MODELS: 5DR03, 5DR04
K072096 · R&D Systems, Inc. · Aug 2007
RETIC-CHEX LINEARITY FOR BC
K070199 · Streck · Feb 2007
E-CHECK (XE)
K063218 · Streck · Dec 2006
R&D LH-NRBC HEMATOLOGY CONTROL
K061320 · R&D Systems, Inc. · Jun 2006
COULTER LIN-C LINEARITY CONTROL, MODELS 7547065, 723503
K061064 · Beckman Coulter, Inc. · May 2006
COULTER 5C CELL CONTROL
K060464 · Beckman Coulter, Inc. · Mar 2006
K061511 · R&D CBC-3D + CRP HEMATOLOGY CONTROL
Download PDF FDA Summary R&D Systems, Inc.