Cleared Special

K072096 - CBC-5D PLUS RETICS HEMATOLOGY CONTROL, MODELS: 5DR03, 5DR04

K072096 is an FDA 510(k) clearance for CBC-5D 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 20-day FDA review.

K072096 · R&D Systems, Inc. · Hematology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
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.

FDA 510(k) Submission Details - K072096

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.

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 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
RETIC-CHEX LINEARITY FOR BC
K070199 · Streck · Feb 2007
E-CHECK (XE)
K063218 · Streck · Dec 2006
R&D CBC-3D + CRP HEMATOLOGY CONTROL
K061511 · R&D Systems, Inc. · Jul 2006
K072096 · CBC-5D PLUS RETICS HEMATOLOGY CONTROL, MODELS: 5DR03, 5DR04
Download PDF FDA Summary R&D Systems, Inc.