Cleared Traditional

SIMULTEST IMK PLUS(TM) (K900078) - FDA 510(k) Clearance

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

K900078 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Hematology device
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Apr 1990
Decision
88d
Days
Class 2
Risk

K900078 is an FDA 510(k) clearance for the SIMULTEST IMK PLUS(TM). Classified as Counter, Differential Cell (product code GKZ), Class II - Special Controls.

Submitted by Bd Becton Dickinson Vacutainer Systems Preanalytic (Franklin Lakes, US). The FDA issued a Cleared decision on April 2, 1990 after a review of 88 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 Bd Becton Dickinson Vacutainer Systems Preanalytic devices

Submission Details

510(k) Number K900078 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 04, 1990
Decision Date April 02, 1990
Days to Decision 88 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
25d faster than avg
Panel avg: 113d · This submission: 88d
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 108
Devices cleared under the same product code (GKZ) and FDA review panel - the closest regulatory comparables to K900078.
ANTI-HUMAN LEU-2A (CD8) PE
K904390 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Dec 1990
SIMULTEST T & B CELL TEST,ANTI-LEU-4 FITC & 12 PE
K904209 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Dec 1990
ANTI-HUMAN LEU-3A (CD4) FITC
K900802 · Bd Becton Dickinson Vacutainer Systems Preanalytic · May 1990
TECHNICON H*2(TM) SYSTEM
K900593 · Technicon Instruments Corp. · Mar 1990
QBC MALARIA SYSTEM
K891276 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Aug 1989
QBC III CENTRIFUGAL HEMATOLOGY SYSTEM
K893423 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Jun 1989