Cleared Traditional

K971469 - COULTER ACT TRON CELL CONTROL

K971469 is the FDA 510(k) clearance for COULTER ACT TRON CELL CONTROL by Coulter Corp.. It is a Class 2 Hematology device (product code JPK) cleared through the Traditional 510(k) pathway after a 69-day FDA review.

K971469 · Coulter Corp. · Hematology device
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Optimized for regulatory review, auditing and printing
Jun 1997
Decision
69d
Days
Class 2
Risk

K971469 is an FDA 510(k) clearance for the COULTER ACT TRON CELL CONTROL. Classified as Mixture, Hematology Quality Control (product code JPK), Class II - Special Controls.

Submitted by Coulter Corp. (Miami, US). The FDA issued a Cleared decision on June 30, 1997 after a review of 69 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 Coulter Corp. devices

Submission Details

510(k) Number K971469 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 22, 1997
Decision Date June 30, 1997
Days to Decision 69 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
44d faster than avg
Panel avg: 113d · This submission: 69d
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 133
Devices cleared under the same product code (JPK) and FDA review panel - the closest regulatory comparables to K971469.
QBC CENTRIFUGAL HEMATOLOGY CONTROL
K984099 · R&D Systems, Inc. · Dec 1998
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
CBC-4K HEMATOLOGY CONTROL
K970331 · R&D Systems, Inc. · Apr 1997
R&D RETIC-PG HEMATOLOGY CONTROL
K961673 · R&D Systems, Inc. · Jul 1996
CALIBRATION VERIFICATION ASSESSMENT (CVA)
K960557 · Streck Laboratories, Inc. · Apr 1996