Cleared Traditional

K971736 - SYSMEX IMMATURE RETICULOCYTE FRACTION (IRF) PARAMETER

K971736 is an FDA 510(k) clearance for SYSMEX IMMATURE RETICULOCYTE FRACTION (..., manufactured by Sysmex Corp.. The device is a Class 2 Hematology device with product code GKZ cleared through the Traditional 510(k) pathway after a 106-day FDA review.

K971736 · Sysmex Corp. · Hematology device
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Aug 1997
Decision
106d
Days
Class 2
Risk

K971736 is an FDA 510(k) clearance for the SYSMEX IMMATURE RETICULOCYTE FRACTION (IRF) PARAMETER. Classified as Counter, Differential Cell (product code GKZ), Class II - Special Controls.

Submitted by Sysmex Corp. (Long Grove, US). The FDA issued a Cleared decision on August 26, 1997 after a review of 106 days - within the typical 510(k) review window.

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 Sysmex Corp. devices

FDA 510(k) Submission Details - K971736

510(k) Number K971736 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 12, 1997
Decision Date August 26, 1997
Days to Decision 106 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
7d faster than avg
Panel avg: 113d · This submission: 106d
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 K971736.
TRITEST CD3 FITC/CD19 PE/CD45 PERCP REAGENT WITH TRUCOUNT ABSOLUTE COUNT TUBES
K970742 · Becton Dickinson Immunocytometry Systems · Oct 1997
ABBOTT CELL-DYN 3200 SYSTEM
K972354 · Abbott Laboratories · Sep 1997
TRUCOUNT ABSOLUTE COUNT TUBES/COUNTING CONTROL BEADS
K970836 · Becton Dickinson Immunocytometry Systems · Aug 1997
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