Cleared Traditional

K984216 - IMMUNO-TROL CONTROL CELLS

K984216 is an FDA 510(k) clearance for IMMUNO-TROL CONTROL CELLS, manufactured by Coulter Corp.. The device is a Class 2 Hematology device with product code JPK cleared through the Traditional 510(k) pathway after a 112-day FDA review.

K984216 · Coulter Corp. · Hematology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 1999
Decision
112d
Days
Class 2
Risk

K984216 is an FDA 510(k) clearance for the IMMUNO-TROL CONTROL CELLS. 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 March 16, 1999 after a review of 112 days - within the typical 510(k) review window.

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 Coulter Corp. devices

FDA 510(k) Submission Details - K984216

510(k) Number K984216 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 24, 1998
Decision Date March 16, 1999
Days to Decision 112 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
1d faster than avg
Panel avg: 113d · This submission: 112d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 166
Devices cleared under the same product code (JPK) and FDA review panel - the closest regulatory comparables to K984216.
RETIC CHEX LINEARITY
K000115 · Streck Laboratories, Inc. · Mar 2000
RETIC-QUINOX
K993496 · Hematronix, Inc. · Nov 1999
SEDRITE PLUS ERYTHROCYTE SEDIMENTATION RATE
K991876 · R&D Systems, Inc. · Jun 1999
CBC-5D HEMATOLOGY CONTROL
K983032 · R&D Systems, Inc. · Feb 1999
QBC CENTRIFUGAL HEMATOLOGY CONTROL
K984099 · R&D Systems, Inc. · Dec 1998
ESR CONTROL-HC HEMATOLOGY ERYTHROCYTE SEDIMENTATION
K972170 · R&D Systems, Inc. · Jul 1997