Cleared Traditional

K243283 - Alinity h-series System

K243283 is an FDA 510(k) clearance for Alinity h-series System, manufactured by Abbott Laboratories. The device is a Class 2 Hematology device with product code GKZ cleared through the Traditional 510(k) pathway after a 126-day FDA review.

K243283 · Abbott Laboratories · Hematology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2025
Decision
126d
Days
Class 2
Risk

K243283 is an FDA 510(k) clearance for the Alinity h-series System. Classified as Counter, Differential Cell (product code GKZ), Class II - Special Controls.

Submitted by Abbott Laboratories (Santa Clara, US). The FDA issued a Cleared decision on February 20, 2025 after a review of 126 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 Abbott Laboratories devices

FDA 510(k) Submission Details - K243283

510(k) Number K243283 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 17, 2024
Decision Date February 20, 2025
Days to Decision 126 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
13d slower than avg
Panel avg: 113d · This submission: 126d
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 K243283.
Tru Hematology Test
K251249 · Truvian Sciences, Inc. · Jan 2026
Sysmex XR-Series (XR-10) Automated Hematology Analyzer
K250943 · Sysmex America, Inc. · Jun 2025
Sysmex XR-Series (XR-20) Automated Hematology Analyzer
K251371 · Sysmex America, Inc. · Jun 2025
Cito CBC System
K240402 · Cytochip, Inc. · Feb 2025
UniCel DxH 900 Coulter Cellular Analysis System
K240252 · Beckman Coulter, Inc. · Jul 2024
Yumizen H2500
K232946 · HORIBA ABX SAS · May 2024