Cleared Special

K051339 - R&D CBC-4K PLUS RETICS HEMATOLOGY CONTROL

K051339 is an FDA 510(k) clearance for R&D CBC-4K PLUS RETICS 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 50-day FDA review.

K051339 · 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 2005
Decision
50d
Days
Class 2
Risk

K051339 is an FDA 510(k) clearance for the R&D CBC-4K PLUS RETICS 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 12, 2005 after a review of 50 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 - K051339

510(k) Number K051339 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 23, 2005
Decision Date July 12, 2005
Days to Decision 50 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
63d faster than avg
Panel avg: 113d · This submission: 50d
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 183
Devices cleared under the same product code (JPK) and FDA review panel - the closest regulatory comparables to K051339.
COULTER 5C CELL CONTROL
K060464 · Beckman Coulter, Inc. · Mar 2006
CELL-CHEX AUTO
K053362 · Streck · Jan 2006
IQ BODY FLUIDS CONTROL
K051706 · Streck · Aug 2005
ABX ERYTROL
K050721 · Horiba Abx · Jun 2005
LIQUICHEK RETICULOCYTE CONTROL (A)
K042836 · Bio-Rad · Nov 2004
RETIC-CHEX FOR CELL-DYN
K042587 · Streck Laboratories, Inc. · Oct 2004
K051339 · R&D CBC-4K PLUS RETICS HEMATOLOGY CONTROL
Download PDF FDA Summary R&D Systems, Inc.