Cleared Traditional

K220031 - Alinity h-series System (FDA 510(k) Clearance)

Class II Hematology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K220031 · Abbott Laboratories · Hematology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2023
Decision
576d
Days
Class 2
Risk

K220031 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 August 4, 2023 after a review of 576 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Hematology submissions.

View all Abbott Laboratories devices

Submission Details

510(k) Number K220031 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 05, 2022
Decision Date August 04, 2023
Days to Decision 576 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
463d slower than avg
Panel avg: 113d · This submission: 576d
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 378
Devices cleared under the same product code (GKZ) and FDA review panel - the closest regulatory comparables to K220031.
Athelas Home
K243348 · Athelas, Inc. · Feb 2026
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
Alinity h-series System
K243283 · Abbott Laboratories · Feb 2025
Cito CBC System
K240402 · Cytochip, Inc. · Feb 2025