Cleared Traditional

K925274 - AUTOCOMP(TM) SOFTWARE AND CALIBRITE(TM)...

K925274 is the FDA 510(k) clearance for AUTOCOMP(TM) SOFTWARE AND CALIBRITE(TM)... by Becton Dickinson Immunocytometry Systems. It is a Class 2 Hematology device (product code GKZ) cleared through the Traditional 510(k) pathway after a 711-day FDA review.

K925274 · Becton Dickinson Immunocytometry Systems · Hematology device
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Sep 1994
Decision
711d
Days
Class 2
Risk

K925274 is an FDA 510(k) clearance for the AUTOCOMP(TM) SOFTWARE AND CALIBRITE(TM) BEADS. 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 September 30, 1994 after a review of 711 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Hematology submissions.

View all Becton Dickinson Immunocytometry Systems devices

Submission Details

510(k) Number K925274 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 19, 1992
Decision Date September 30, 1994
Days to Decision 711 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
598d slower than avg
Panel avg: 113d · This submission: 711d
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 K925274.
MONOCLONAL MOUSE ANTI-HUMAN B-CELL
K943284 · Dako Corp. · Nov 1994
MONOCLONAL MOUSE ANTI-HUMAN T-CELL, CD8, RPE-CONJUGATED, CLONE DK25
K944253 · Dako Corp. · Nov 1994
MONOCLONAL MOUSE ANTI-HUMAN T-CELL
K942797 · Dako Corp. · Nov 1994
COULTER MH015 (DIFFERENTIAL CELL COUNTER)
K930913 · Coulter Corp. · Aug 1993
COULTER STKS WITH RETICULOCYTE ANALYSIS CAPABILITY
K932030 · Coulter Corp. · Aug 1993
ABBOTT ENCOUNTER(TM)Q
K930309 · Abbott Laboratories · Jul 1993