Cleared Traditional

CELL-DYN 4000 IMMUNO T-CELL (CD3/4/8) ASSAY (K010953) - FDA 510(k) Clearance

Class II Hematology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K010953 · Abbott Laboratories · Hematology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2001
Decision
68d
Days
Class 2
Risk

K010953 is an FDA 510(k) clearance for the CELL-DYN 4000 IMMUNO T-CELL (CD3/4/8) ASSAY. Classified as Counter, Differential Cell (product code GKZ), Class II - Special Controls.

Submitted by Abbott Laboratories (Santa Clara, US). The FDA issued a Cleared decision on June 6, 2001 after a review of 68 days - a notably fast clearance cycle.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 864.5220 - 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 Abbott Laboratories devices

Submission Details

510(k) Number K010953 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 30, 2001
Decision Date June 06, 2001
Days to Decision 68 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
45d faster than avg
Panel avg: 113d · This submission: 68d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code GKZ Counter, Differential Cell
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 864.5220
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 - GKZ Counter, Differential Cell

All 124
Devices cleared under the same product code (GKZ) and FDA review panel - the closest regulatory comparables to K010953.
MODIFICATION TO COULTER LH 750 HEMATOLOGY ANALYZER, MODEL 6605632
K022161 · Beckman Coulter, Inc. · Jul 2002
CELL-DYN 3200 SYSTEM WITH ABSOLUTE AND PERCENT RETICULOCYTE
K012934 · Abbott Laboratories · Sep 2001
COULTER LH 750 HEMATOLOGY ANALYZER, MODEL 6605632
K011342 · Beckman Coulter, Inc. · Jul 2001
COULTER HMX ANALYZER, MODEL 6605523, COULTER HMX WITH AUTOLOADER, MODEL 6605526
K010765 · Beckman Coulter, Inc. · Apr 2001
MODIFICATION OF: CELL-DYN 1200 SYSTEM
K992444 · Abbott Laboratories · Sep 1999
QBC STAR CENTRIFUGAL HEMATOLOGY SYSTEM
K992849 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Sep 1999