Cleared Special

K982231 - STATUSFLOW

K982231 is an FDA 510(k) clearance for STATUSFLOW, manufactured by R&D Systems, Inc.. The device is a Class 2 Hematology device with product code GKZ cleared through the Special 510(k) pathway after a 25-day FDA review.

K982231 · R&D Systems, Inc. · Hematology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jul 1998
Decision
25d
Days
Class 2
Risk

K982231 is an FDA 510(k) clearance for the STATUSFLOW. Classified as Counter, Differential Cell (product code GKZ), Class II - Special Controls.

Submitted by R&D Systems, Inc. (Minneapolis, US). The FDA issued a Cleared decision on July 20, 1998 after a review of 25 days - a notably fast clearance cycle.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 864.5220 - the FDA hematology device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K982231

510(k) Number K982231 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 25, 1998
Decision Date July 20, 1998
Days to Decision 25 days
Submission Type Special
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
88d faster than avg
Panel avg: 113d · This submission: 25d
Pathway characteristics
Modification to existing cleared device.

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 K982231.
BAYER ADVIA 60 HEMATOLOGY SYSTEM (IN VITRO DIAGNOSTIC SYSTEM)
K982802 · Bayer Corp. · Sep 1998
MASCOT MD HEMATOLOGY ANALYZER, MODEL MD 800
K981568 · Cdc Technologies, Inc. · Aug 1998
DAKO MOUSE ANTI-HUMAN B-CELL, CD19/RPE-CY5, CLONE HD37
K980635 · Dako Corp. · Jul 1998
ABBOTT CELL-DYN 4000 IMMUNOPIT (CD61) ASSAY
K981342 · Abbott Laboratories · Jun 1998
MULTITEST CD3/CD16+56/CD45/CD19 REAGENT AND MULTITEST IMK KIT LYSING SOLUTION
K980858 · Becton Dickinson Immunocytometry Systems · May 1998
ABBOTT CELL-DYN 3000 SERIES HEMATOLOGY SYSTEMS
K980614 · Abbott Laboratories · Apr 1998
K982231 · STATUSFLOW
Download PDF FDA Summary R&D Systems, Inc.