Cleared Traditional

K974360 - MULTITEST CD3/CD8/CD45/CD4

K974360 is an FDA 510(k) clearance for MULTITEST CD3/CD8/CD45/CD4, manufactured by Becton Dickinson Immunocytometry Systems. The device is a Class 2 Hematology device with product code GKZ cleared through the Traditional 510(k) pathway after a 112-day FDA review.

K974360 · Becton Dickinson Immunocytometry Systems · Hematology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 1998
Decision
112d
Days
Class 2
Risk

K974360 is an FDA 510(k) clearance for the MULTITEST CD3/CD8/CD45/CD4. Classified as Counter, Differential Cell (product code GKZ), Class II - Special Controls.

Submitted by Becton Dickinson Immunocytometry Systems (San Jose, US). The FDA issued a Cleared decision on March 11, 1998 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 864.5220 - 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: 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 Becton Dickinson Immunocytometry Systems devices

FDA 510(k) Submission Details - K974360

510(k) Number K974360 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 19, 1997
Decision Date March 11, 1998
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.

GKZ Device Classification - Class 2, Special Controls

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 295
Devices cleared under the same product code (GKZ) and FDA review panel - the closest regulatory comparables to K974360.
ABBOTT CELL-DYN 4000 IMMUNOPIT (CD61) ASSAY
K981342 · Abbott Laboratories · Jun 1998
MULTITEST CD3/CD16+56/CD45/CD19 REAGENT AND MULTITEST IMK KIT LYSING SOLUTION
K980858 · Becton Dickinson Immunocytometry Systems · May 1998
ABBOTT CELL-DYN 3000 SERIES HEMATOLOGY SYSTEMS
K980614 · Abbott Laboratories · Apr 1998
FACSCOMP SOFTWARE AND CALIBRITE BEADS FOR USE IN FLOW CYTOMETER INSTRUMENT SET
K973483 · Becton Dickinson Immunocytometry Systems · Feb 1998
TRI TEST REAGENT CD4 FIT C/CD8 PE/CD3 PERCP WITH TRUCOUNT ABSOLUTE COUNT TUBES
K971205 · Becton Dickinson Immunocytometry Systems · Dec 1997
TRITEST REAGENT CD3 FITC/CD16+CD56 PE/CD45 PERCP
K971110 · Becton Dickinson Immunocytometry Systems · Nov 1997