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)
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.

View all R&D Systems, Inc. devices

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 166
Devices cleared under the same product code (JPK) and FDA review panel - the closest regulatory comparables to K061320.
RETIC-CHEX LINEARITY FOR BC
K070199 · Streck · Feb 2007
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K063218 · Streck · Dec 2006
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K061511 · R&D Systems, Inc. · Jul 2006
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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