Cleared Traditional

K090810 - THERMO SCIENTIFIC CYTO-CAL COUNT TUBES

K090810 is an FDA 510(k) clearance for THERMO SCIENTIFIC CYTO-CAL COUNT TUBES, manufactured by Microgenics Corp.. The device is a Class 2 Hematology device with product code GKZ cleared through the Traditional 510(k) pathway after a 177-day FDA review.

K090810 · Microgenics Corp. · Hematology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2009
Decision
177d
Days
Class 2
Risk

K090810 is an FDA 510(k) clearance for the THERMO SCIENTIFIC CYTO-CAL COUNT TUBES. Classified as Counter, Differential Cell (product code GKZ), Class II - Special Controls.

Submitted by Microgenics Corp. (Fremont Blvd., US). The FDA issued a Cleared decision on September 18, 2009 after a review of 177 days - an extended review 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: 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 Microgenics Corp. devices

FDA 510(k) Submission Details - K090810

510(k) Number K090810 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 25, 2009
Decision Date September 18, 2009
Days to Decision 177 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
64d slower than avg
Panel avg: 113d · This submission: 177d
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 K090810.
ADVIA 2120/2120I BODY FLUIDS
K090346 · Siemens Healthcare Diagnostics · Jul 2010
BC-3200 AUTO HEMATOLOGY ANALYZER,M-30D DILUENT, M-30R RINSE, M-30CFL LYSE, M-30E-Z CLEANSER, M-30PROBE CLEANSER, BC-3D C
K093394 · Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · Apr 2010
SYSMEX MODEL XT-4000I
K091313 · Sysmex America, Inc. · Mar 2010
CELL-DYN EMERALD SYSTEM
K081495 · Abbott Laboratories · Feb 2009
UNICEL DXH 800 COULTER CELLULAR ANALYSIS SYSTEM
K081930 · Beckman Coulter, Inc. · Dec 2008
SYSMEX XT-SERIES IG PARAMETER,SYSMEX XT-SERIES RET-HE PARAMETER
K081890 · Sysmex America, Inc. · Oct 2008