Cleared Special

K042094 - R&D CBC-XE HEMATOLOGY CONTROL

K042094 is an FDA 510(k) clearance for R&D CBC-XE 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 29-day FDA review.

K042094 · R&D Systems, Inc. · Hematology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Sep 2004
Decision
29d
Days
Class 2
Risk

K042094 is an FDA 510(k) clearance for the R&D CBC-XE 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 September 1, 2004 after a review of 29 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 - K042094

510(k) Number K042094 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 03, 2004
Decision Date September 01, 2004
Days to Decision 29 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
84d faster than avg
Panel avg: 113d · This submission: 29d
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 K042094.
LIQUICHEK RETICULOCYTE CONTROL (A)
K042836 · Bio-Rad · Nov 2004
RETIC-CHEX FOR CELL-DYN
K042587 · Streck Laboratories, Inc. · Oct 2004
METER TRAX TRILEVEL, LOW LEVEL, MID LEVEL, HIGH LEVEL TRILEVEL MINIPAK
K042336 · Bio-Rad Laboratories, Inc. · Oct 2004
LIQUICHEK HEMATOLOGY CONTROL (A)
K041457 · Bio-Rad · Jun 2004
CDS 3-PD HEMATOLOGY CONTROLS
K024173 · Clinical Diagnostic Solutions, Inc. · Jan 2003
ADVIA TESTPOINT CSF CONTROL
K022968 · Bayer Diagnostics Corp. · Sep 2002
K042094 · R&D CBC-XE HEMATOLOGY CONTROL
Download PDF FDA Summary R&D Systems, Inc.