Cleared Traditional

K950057 - TRITEST CONTROL REAGENT IGG1 FITC/IGFG1...

K950057 is the FDA 510(k) clearance for TRITEST CONTROL REAGENT IGG1 FITC/IGFG1... by Becton Dickinson Immunocytometry Systems. It is a Class 2 Hematology device (product code GKZ) cleared through the Traditional 510(k) pathway after a 229-day FDA review.

K950057 · Becton Dickinson Immunocytometry Systems · Hematology device
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Aug 1995
Decision
229d
Days
Class 2
Risk

K950057 is an FDA 510(k) clearance for the TRITEST CONTROL REAGENT IGG1 FITC/IGFG1 PE/CD45 PERCP. 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 August 22, 1995 after a review of 229 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 Becton Dickinson Immunocytometry Systems devices

Submission Details

510(k) Number K950057 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 05, 1995
Decision Date August 22, 1995
Days to Decision 229 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
116d slower than avg
Panel avg: 113d · This submission: 229d
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 K950057.
CELL-DYN 3500 MULTI-PARAMETER AUTOMATED HEMATOLOGY ANALYZER
K951496 · Abbott Laboratories · Oct 1995
ROCHE COBAS MICROS HEMATOLOGY ANALYZER
K953448 · Roche Diagnostic Systems, Inc. · Oct 1995
CYTO-STAT/COULTER CLONE CD3-ECD/T4-RD1/T8-FITC MONOCLONAL ANTIBOEY REAGENT
K950742 · Coulter Corp. · Aug 1995
OPTICLONE CD4FITC/CD8 PE MONOCLONAL ANTIBODIES
K952789 · Immunotech Corp. · Aug 1995
COULTER MH025A
K950949 · Coulter Corp. · Jul 1995
OPTICLONE CD3/CD4 MONOCLONAL ANTIBODIES
K950626 · Immunotech Corp. · May 1995