Cleared Special

K003991 - CD-CAL PLUS CALIBRATOR

K003991 is an FDA 510(k) clearance for CD-CAL PLUS CALIBRATOR, manufactured by R&D Systems, Inc.. The device is a Class 2 Hematology device with product code KRX cleared through the Special 510(k) pathway after a 21-day FDA review.

K003991 · R&D Systems, Inc. · Hematology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jan 2001
Decision
21d
Days
Class 2
Risk

K003991 is an FDA 510(k) clearance for the CD-CAL PLUS CALIBRATOR. Classified as Calibrator For Cell Indices (product code KRX), Class II - Special Controls.

Submitted by R&D Systems, Inc. (Minneapolis, US). The FDA issued a Cleared decision on January 16, 2001 after a review of 21 days - a notably fast clearance cycle.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 864.8150 - 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 - K003991

510(k) Number K003991 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 26, 2000
Decision Date January 16, 2001
Days to Decision 21 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
92d faster than avg
Panel avg: 113d · This submission: 21d
Pathway characteristics
Modification to existing cleared device.

KRX Device Classification - Class 2, Special Controls

Product Code KRX Calibrator For Cell Indices
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 864.8150
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 - KRX Calibrator For Cell Indices

All 15
Devices cleared under the same product code (KRX) and FDA review panel - the closest regulatory comparables to K003991.
CELL-DYN 22 PLUS CALIBRATOR
K111204 · Streck · Dec 2011
X-CAL
K083200 · Streck · Feb 2009
CAL-CHEX CD PLUS
K020469 · Streck Laboratories, Inc. · Apr 2002
CDS LTX CONTROL LATEX PARTICLE SUSPENSION AND PRIMER
K993375 · Clinical Diagnostic Solutions, Inc. · Dec 1999
CBC-CAL PLUS HEMATOLOGY CALIBRATOR
K955925 · R&D Systems, Inc. · Feb 1996
3K-CAL HEMATOLOGY CALIBRATOR/MULTIPLE
K912357 · R&D Systems, Inc. · Jul 1991
K003991 · CD-CAL PLUS CALIBRATOR
Download PDF FDA Summary R&D Systems, Inc.