Cleared Traditional

K961623 - FACSCOMP SOFTWARE & CALIBRITE 3 COLOR B...

K961623 is the FDA 510(k) clearance for FACSCOMP SOFTWARE & CALIBRITE 3 COLOR B... by Becton Dickinson Monoclonal Center. It is a Class 2 Hematology device (product code GKZ) cleared through the Traditional 510(k) pathway after a 42-day FDA review.

K961623 · Becton Dickinson Monoclonal Center · Hematology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 1996
Decision
42d
Days
Class 2
Risk

K961623 is an FDA 510(k) clearance for the FACSCOMP SOFTWARE & CALIBRITE 3 COLOR BEADS KIT/CALIBRITE PERCP BEADS. Classified as Counter, Differential Cell (product code GKZ), Class II - Special Controls.

Submitted by Becton Dickinson Monoclonal Center (San Jose, US). The FDA issued a Cleared decision on June 7, 1996 after a review of 42 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 Becton Dickinson Monoclonal Center devices

Submission Details

510(k) Number K961623 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 26, 1996
Decision Date June 07, 1996
Days to Decision 42 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
71d faster than avg
Panel avg: 113d · This submission: 42d
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 194
Devices cleared under the same product code (GKZ) and FDA review panel - the closest regulatory comparables to K961623.
R & D SYSTEMS' WHOLE BLOOD FLOW CONTROL, (R & D - WBFC)
K961610 · R&D Systems, Inc. · Jul 1996
MOUSE ANTI-HUMAN CD3, T-CELL/FITC & CD19, B-CELL/RPE
K960531 · Dako Corp. · Jun 1996
MOUSE ANTI-HUMAN CD2, T-CELL/FITC AND MOUSE ANTI-HUMAN CD19, B-CELL/RPE
K961435 · Dako Corp. · Jun 1996
CELL DYN 3000 MULTI-PARAMETER AUTOMATED HEMATOLOGY ANALYZER (MODIFICATION)
K955673 · Abbott Laboratories · May 1996
MOUSE ANTI-HUMAN CD4, T-CELL, HELPER/INDUCER/FITC & CD8, T-CELL, SUPPRESSOR/CYTOTOXIC/RPE
K960887 · Dako Corp. · May 1996
ORTHO-MUNE OK-COMBO CD3-FITC/CD4-PE (OKT2/OKT4A) MONOCLONAL ANTIBODY (MURINE)
K950568 · Ortho Diagnostic Systems, Inc. · May 1996