Cleared Special

K061320 - R&D LH-NRBC HEMATOLOGY CONTROL

K061320 is an FDA 510(k) clearance for R&D LH-NRBC 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 22-day FDA review.

K061320 · R&D Systems, Inc. · Hematology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jun 2006
Decision
22d
Days
Class 2
Risk

K061320 is an FDA 510(k) clearance for the R&D LH-NRBC 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 June 2, 2006 after a review of 22 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 - K061320

510(k) Number K061320 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 11, 2006
Decision Date June 02, 2006
Days to Decision 22 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
91d faster than avg
Panel avg: 113d · This submission: 22d
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 K061320.
RETIC-CHEX LINEARITY FOR BC
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K063218 · Streck · Dec 2006
R&D CBC-3D + CRP HEMATOLOGY CONTROL
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K061064 · Beckman Coulter, Inc. · May 2006
COULTER 5C CELL CONTROL
K060464 · Beckman Coulter, Inc. · Mar 2006
CELL-CHEX AUTO
K053362 · Streck · Jan 2006
K061320 · R&D LH-NRBC HEMATOLOGY CONTROL
Download PDF FDA Summary R&D Systems, Inc.