Cleared Traditional

K895127 - ARGOS

K895127 is an FDA 510(k) clearance for ARGOS, manufactured by Abx, Inc.. The device is a Class 2 Hematology device with product code GKZ cleared through the Traditional 510(k) pathway after a 54-day FDA review.

K895127 · Abx, Inc. · Hematology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 1989
Decision
54d
Days
Class 2
Risk

K895127 is an FDA 510(k) clearance for the ARGOS. Classified as Counter, Differential Cell (product code GKZ), Class II - Special Controls.

Submitted by Abx, Inc. (Horsham, US). The FDA issued a Cleared decision on October 10, 1989 after a review of 54 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Abx, Inc. devices

FDA 510(k) Submission Details - K895127

510(k) Number K895127 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 17, 1989
Decision Date October 10, 1989
Days to Decision 54 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
59d faster than avg
Panel avg: 113d · This submission: 54d
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 304
Devices cleared under the same product code (GKZ) and FDA review panel - the closest regulatory comparables to K895127.
COULTER JT3
K896873 · Coulter Corp. · Mar 1990
TECHNICON H*2(TM) SYSTEM
K900593 · Technicon Instruments Corp. · Mar 1990
SIMULTEST IMK FOR FACS ANALYZER OR FACSCAN
K890349 · Becton Dickinson Immunocytometry Systems · Dec 1989
QBC MALARIA SYSTEM
K891276 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Aug 1989
QBC III CENTRIFUGAL HEMATOLOGY SYSTEM
K893423 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Jun 1989
CELL-DYN 3000 MULTI-PARAMETER HEMATOLOGY ANALYER
K890491 · Abbott Diagnostics · Apr 1989