Cleared Traditional

K100607 - COULTER 4C-EX 300 CELL CONTROL

K100607 is the FDA 510(k) clearance for COULTER 4C-EX 300 CELL CONTROL by Beckman Coulter, Inc.. It is a Class 2 Hematology device (product code JPK) cleared through the Traditional 510(k) pathway after a 260-day FDA review.

K100607 · Beckman Coulter, Inc. · Hematology device
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Nov 2010
Decision
260d
Days
Class 2
Risk

K100607 is an FDA 510(k) clearance for the COULTER 4C-EX 300 CELL CONTROL. Classified as Mixture, Hematology Quality Control (product code JPK), Class II - Special Controls.

Submitted by Beckman Coulter, Inc. (Miami, US). The FDA issued a Cleared decision on November 18, 2010 after a review of 260 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Hematology review framework, consistent with the majority of Class II 510(k) submissions.

View all Beckman Coulter, Inc. devices

Submission Details

510(k) Number K100607 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 03, 2010
Decision Date November 18, 2010
Days to Decision 260 days
Submission Type Traditional
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
147d slower than avg
Panel avg: 113d · This submission: 260d
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 125
Devices cleared under the same product code (JPK) and FDA review panel - the closest regulatory comparables to K100607.
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K100790 · Beckman Coulter, Inc. · Dec 2010
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K091303 · Bio-Rad Laboratories · Aug 2010
R & D SYSTEMS XERET HEMATOLOGY CONTROL
K100050 · R&D Systems, Inc. · Jan 2010
R&D SYSTEMS TETIC-I PLUS HEMOTOLOGY CONTROL
K091433 · R&D Systems, Inc. · Oct 2009