Cleared Traditional

K910679 - GENESIS I AUTOMATED CELL COUNTER

K910679 is an FDA 510(k) clearance for GENESIS I AUTOMATED CELL COUNTER, manufactured by Alicia Diagnostics, Inc.. The device is a Class 2 Hematology device with product code GKL cleared through the Traditional 510(k) pathway after a 81-day FDA review.

K910679 · Alicia Diagnostics, Inc. · Hematology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 1991
Decision
81d
Days
Class 2
Risk

K910679 is an FDA 510(k) clearance for the GENESIS I AUTOMATED CELL COUNTER. Classified as Counter, Cell, Automated (particle Counter) (product code GKL), Class II - Special Controls.

Submitted by Alicia Diagnostics, Inc. (Oviedo, US). The FDA issued a Cleared decision on May 7, 1991 after a review of 81 days - a notably fast clearance cycle.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 864.5200 - 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 Alicia Diagnostics, Inc. devices

FDA 510(k) Submission Details - K910679

510(k) Number K910679 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 15, 1991
Decision Date May 07, 1991
Days to Decision 81 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
32d faster than avg
Panel avg: 113d · This submission: 81d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GKL Device Classification - Class 2, Special Controls

Product Code GKL Counter, Cell, Automated (particle Counter)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 864.5200
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 - GKL Counter, Cell, Automated (particle Counter)

All 99
Devices cleared under the same product code (GKL) and FDA review panel - the closest regulatory comparables to K910679.
SYSMEX F-810
K910849 · Toa Medical Electronics USA, Inc. · Jul 1991
SYSMEX F-610
K911172 · Toa Medical Electronics USA, Inc. · Jul 1991
SYSMEX F-310
K911173 · Toa Medical Electronics USA, Inc. · Jul 1991
SYSMEX R-1000 AUTOMATED RETICULOCYTE ANALYZER
K894539 · Toa Medical Electronics USA, Inc. · Sep 1989
COULTER FLOW RETICULOCYTE REAGENT
K885332 · Coulter Electronics, Inc. · Feb 1989
NOVA CELLTRAK 11 AUTO. HEMA. ANALYZER, CALIBRATORS
K884618 · Nova Biomedical Corp. · Jan 1989