Cleared Traditional

SIMULTEST(TM) IMK-LYMPHOCYTE (K913192) - FDA 510(k) Clearance

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

K913192 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Hematology device
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Feb 1992
Decision
203d
Days
Class 2
Risk

K913192 is an FDA 510(k) clearance for the SIMULTEST(TM) IMK-LYMPHOCYTE. 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 February 6, 1992 after a review of 203 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. 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 Bd Becton Dickinson Vacutainer Systems Preanalytic devices

Submission Details

510(k) Number K913192 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 18, 1991
Decision Date February 06, 1992
Days to Decision 203 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
90d slower than avg
Panel avg: 113d · This submission: 203d
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 K913192.
TECHNICON H* 3 RTX SYSTEM (IN-VITRO DIAG. SYSTEM)
K930148 · Heraeus Kulzer, Inc. · May 1993
TECHNICON H*2
K923237 · Heraeus Kulzer, Inc. · Sep 1992
SOFTWARE MODIFICATION FOR MILES H*1 S/W VER. 1.5
K920949 · Heraeus Kulzer, Inc. · May 1992
FACSTRAK FLOW CYTOMETER
K914014 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Dec 1991
MONOCLONAL ANTIBODY ANTI-CD19
K901186 · Sigma Chemical Co. · Oct 1991
MONOCLONAL ANTIBODY ANTI-CD2
K901187 · Sigma Chemical Co. · Oct 1991