Cleared Traditional

K890349 - SIMULTEST IMK FOR FACS ANALYZER OR FACSCAN

K890349 is an FDA 510(k) clearance for SIMULTEST IMK FOR FACS ANALYZER OR FACSCAN, 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 339-day FDA review.

K890349 · Becton Dickinson Immunocytometry Systems · Hematology device
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Dec 1989
Decision
339d
Days
Class 2
Risk

K890349 is an FDA 510(k) clearance for the SIMULTEST IMK FOR FACS ANALYZER OR FACSCAN. 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 December 29, 1989 after a review of 339 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: Standard predicate-based submission. Elevated predicate reliance profile. 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 - K890349

510(k) Number K890349 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 24, 1989
Decision Date December 29, 1989
Days to Decision 339 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
226d slower than avg
Panel avg: 113d · This submission: 339d
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 K890349.
SIMULTEST IMK PLUS(TM)
K900078 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Apr 1990
COULTER JT3
K896873 · Coulter Corp. · Mar 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
CELL-DYN 3000 MULTI-PARAMETER HEMATOLOGY ANALYER
K890491 · Abbott Diagnostics · Apr 1989