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
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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.

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 380
Devices cleared under the same product code (GKZ) and FDA review panel - the closest regulatory comparables to K890349.
COULTER CLONE T4 MONOCLONAL ANTIBODY
K893852 · Coulter Immunology · Mar 1990
COULTER CLONE T8 MONOCLONAL ANTIBODY
K893853 · Coulter Immunology · Mar 1990
COULTER CLONE(R) MY4 MONOCLONAL ANTIBODY
K894179 · Coulter Immunology · Feb 1990
CYTO-STAT/COULTER CLONE T4-RD1/T8-FITC MONO ANTI
K895917 · Coulter Immunology · Dec 1989
ARGOS
K895127 · Abx, Inc. · Oct 1989
COULTER CLONE MO2
K884605 · Coulter Immunology · Aug 1989
K890349 · SIMULTEST IMK FOR FACS ANALYZER OR FACSCAN
Download PDF Becton Dickinson Immu…