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
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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.

View all R&D Systems, Inc. devices

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 166
Devices cleared under the same product code (JPK) and FDA review panel - the closest regulatory comparables to K051339.
COULTER 5C CELL CONTROL
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IQ BODY FLUIDS CONTROL
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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