Cleared Traditional

K024173 - CDS 3-PD HEMATOLOGY CONTROLS

K024173 is the FDA 510(k) clearance for CDS 3-PD HEMATOLOGY CONTROLS by Clinical Diagnostic Solutions, Inc.. It is a Class 2 Hematology device (product code JPK) cleared through the Traditional 510(k) pathway after a 27-day FDA review.

K024173 · Clinical Diagnostic Solutions, Inc. · Hematology device
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Jan 2003
Decision
27d
Days
Class 2
Risk

K024173 is an FDA 510(k) clearance for the CDS 3-PD HEMATOLOGY CONTROLS. Classified as Mixture, Hematology Quality Control (product code JPK), Class II - Special Controls.

Submitted by Clinical Diagnostic Solutions, Inc. (Plantation, US). The FDA issued a Cleared decision on January 14, 2003 after a review of 27 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Clinical Diagnostic Solutions, Inc. devices

Submission Details

510(k) Number K024173 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 18, 2002
Decision Date January 14, 2003
Days to Decision 27 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
86d faster than avg
Panel avg: 113d · This submission: 27d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 134
Devices cleared under the same product code (JPK) and FDA review panel - the closest regulatory comparables to K024173.
METER TRAX TRILEVEL, LOW LEVEL, MID LEVEL, HIGH LEVEL TRILEVEL MINIPAK
K042336 · Bio-Rad Laboratories, Inc. · Oct 2004
R&D CBC-XE HEMATOLOGY CONTROL
K042094 · R&D Systems, Inc. · Sep 2004
LIQUICHEK HEMATOLOGY CONTROL (A)
K041457 · Bio-Rad · Jun 2004
MODIFICATION TO PARA 5X
K021922 · Streck Laboratories, Inc. · Jun 2002
R & D BODY FLUID CONTROL
K020229 · R&D Systems, Inc. · Feb 2002
R&D RET-LINE KIT
K013898 · R&D Systems, Inc. · Jan 2002