Cleared Special

K072096 - CBC-5D PLUS RETICS HEMATOLOGY CONTROL

K072096 is the FDA 510(k) clearance for CBC-5D PLUS RETICS HEMATOLOGY CONTROL by R&D Systems, Inc.. It is a Class 2 Hematology device (product code JPK) cleared through the Special 510(k) pathway after a 20-day FDA review.

K072096 · R&D Systems, Inc. · Hematology device
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Aug 2007
Decision
20d
Days
Class 2
Risk

K072096 is an FDA 510(k) clearance for the CBC-5D PLUS RETICS HEMATOLOGY CONTROL, MODELS: 5DR03, 5DR04. 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 August 20, 2007 after a review of 20 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

Submission Details

510(k) Number K072096 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 31, 2007
Decision Date August 20, 2007
Days to Decision 20 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
93d faster than avg
Panel avg: 113d · This submission: 20d
Pathway characteristics
Modification to existing cleared device.

Device Classification

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 133
Devices cleared under the same product code (JPK) and FDA review panel - the closest regulatory comparables to K072096.
HCT EXTENDED HEMATOLOGY CONTROL, MODEL HCT004
K073178 · R&D Systems, Inc. · Dec 2007
CSF AUTOMATED CONTROL, MODELS CSF001, CSF003
K072846 · R&D Systems, Inc. · Nov 2007
HC WBC HEMATOLOGY CONTROL, MODEL: WBC00S
K072268 · R&D Systems, Inc. · Nov 2007
R&D CBC-3D + CRP HEMATOLOGY CONTROL
K061511 · R&D Systems, Inc. · Jul 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