Cleared Traditional

K152776 - Glocyte Automated Cell Counter System

K152776 is an FDA 510(k) clearance for Glocyte Automated Cell Counter System, manufactured by Advanced Instruments, Inc.. The device is a Class 2 Hematology device with product code GKL cleared through the Traditional 510(k) pathway after a 245-day FDA review.

K152776 · Advanced Instruments, Inc. · Hematology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2016
Decision
245d
Days
Class 2
Risk

K152776 is an FDA 510(k) clearance for the Glocyte Automated Cell Counter System. Classified as Counter, Cell, Automated (particle Counter) (product code GKL), Class II - Special Controls.

Submitted by Advanced Instruments, Inc. (Norwood, US). The FDA issued a Cleared decision on May 27, 2016 after a review of 245 days - an extended review 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: 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 Advanced Instruments, Inc. devices

FDA 510(k) Submission Details - K152776

510(k) Number K152776 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 25, 2015
Decision Date May 27, 2016
Days to Decision 245 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
132d slower than avg
Panel avg: 113d · This submission: 245d
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 91
Devices cleared under the same product code (GKL) and FDA review panel - the closest regulatory comparables to K152776.
MODIFICATION TO BAYER ADVIA 2120 HEMATOLOGY ANALYZER WITH AUTOSLIDE SYSTEM
K051693 · Bayer Healthcare, LLC · Dec 2005
SYSMEX POCH-100I
K032677 · Sysmex America, Inc. · Feb 2004
ADVIA 120 HEMATOLOGY SYSTEM, CEREBROSPINAL FLUID METHOD
K022331 · Bayer Diagnostics Corp. · Sep 2002
COULTER Z2 ANALYZER
K991070 · Coulter Corp. · May 1999
ADVIA 120 HEMATOLOGY SYSTEM, IN VITRO DIAGNOSTIC SYSTEM
K971998 · Bayer Corp. · Aug 1997
COULTER GEN-S SYSTEM
K962988 · Coulter Corp. · Oct 1996