Cleared Special

K984099 - QBC CENTRIFUGAL HEMATOLOGY CONTROL

K984099 is an FDA 510(k) clearance for QBC CENTRIFUGAL 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 23-day FDA review.

K984099 · R&D Systems, Inc. · Hematology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Dec 1998
Decision
23d
Days
Class 2
Risk

K984099 is an FDA 510(k) clearance for the QBC CENTRIFUGAL 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 December 10, 1998 after a review of 23 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 - K984099

510(k) Number K984099 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 17, 1998
Decision Date December 10, 1998
Days to Decision 23 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
90d faster than avg
Panel avg: 113d · This submission: 23d
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 K984099.
SEDRITE PLUS ERYTHROCYTE SEDIMENTATION RATE
K991876 · R&D Systems, Inc. · Jun 1999
IMMUNO-TROL CONTROL CELLS
K984216 · Coulter Corp. · Mar 1999
CBC-5D HEMATOLOGY CONTROL
K983032 · R&D Systems, Inc. · Feb 1999
ESR CONTROL-HC HEMATOLOGY ERYTHROCYTE SEDIMENTATION
K972170 · R&D Systems, Inc. · Jul 1997
ESR CONTROL-M HEMATOLOGY ERYTHROCYTE SEDIMENTATION
K972172 · R&D Systems, Inc. · Jul 1997
COULTER ACT TRON CELL CONTROL
K971469 · Coulter Corp. · Jun 1997
K984099 · QBC CENTRIFUGAL HEMATOLOGY CONTROL
Download PDF FDA Summary R&D Systems, Inc.