Cleared Traditional

K970326 - TRITEST REAGENT CD3 FITC/CD8 PE/CD45 PERCP

Also marketed or referenced as:
WITH TRUCOUNT ABSOLUTE COUNT TUBES

K970326 is an FDA 510(k) clearance for TRITEST REAGENT CD3 FITC/CD8 PE/CD45 PERCP, 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 297-day FDA review.

K970326 · Becton Dickinson Immunocytometry Systems · Hematology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 1997
Decision
297d
Days
Class 2
Risk

K970326 is an FDA 510(k) clearance for the TRITEST REAGENT CD3 FITC/CD8 PE/CD45 PERCP. 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 November 21, 1997 after a review of 297 days - an extended review 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: 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 - K970326

510(k) Number K970326 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 28, 1997
Decision Date November 21, 1997
Days to Decision 297 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
184d slower than avg
Panel avg: 113d · This submission: 297d
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 K970326.
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
TRITEST REAGENT CD3 FITC/CD4 PE/CD45 PERCP
K965053 · Becton Dickinson Immunocytometry Systems · Nov 1997
COULTER AC.T DIFF ANALYZER
K973634 · Coulter Corp. · Oct 1997
TRITEST CD3 FITC/CD19 PE/CD45 PERCP REAGENT WITH TRUCOUNT ABSOLUTE COUNT TUBES
K970742 · Becton Dickinson Immunocytometry Systems · Oct 1997
ABBOTT CELL-DYN 3200 SYSTEM
K972354 · Abbott Laboratories · Sep 1997