Cleared Traditional

K970836 - TRUCOUNT ABSOLUTE COUNT TUBES/COUNTING ...

K970836 is the FDA 510(k) clearance for TRUCOUNT ABSOLUTE COUNT TUBES/COUNTING ... by Becton Dickinson Immunocytometry Systems. It is a Class 2 Hematology device (product code GKZ) cleared through the Traditional 510(k) pathway after a 183-day FDA review.

K970836 · Becton Dickinson Immunocytometry Systems · Hematology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 1997
Decision
183d
Days
Class 2
Risk

K970836 is an FDA 510(k) clearance for the TRUCOUNT ABSOLUTE COUNT TUBES/COUNTING CONTROL BEADS. 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 26, 1997 after a review of 183 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 K970836 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 24, 1997
Decision Date August 26, 1997
Days to Decision 183 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
70d slower than avg
Panel avg: 113d · This submission: 183d
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 K970836.
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ABBOTT CELL-DYN 3200 SYSTEM
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ABBOTT CELL-DYN 4000 IMMATURE RETICULOCYTE FRACTION (IRF)
K971152 · Abbott Laboratories · Aug 1997
ORTHO-MUNE OKT 4A (CD4) - MONOCLONAL ANTIBODY (MURINE) FITC CONJUGATE
K951459 · Ortho Diagnostic Systems, Inc. · Jul 1997
MOUSE ANTI-HUMAN CD45, LEUCOCYTE COMMON ANTIGEN (LCA)/FITC AND CD14, MONOCYTE/RPE
K964974 · Dako Corp. · Jun 1997