Cleared Traditional

K090346 - ADVIA 2120/2120I BODY FLUIDS

K090346 is an FDA 510(k) clearance for ADVIA 2120/2120I BODY FLUIDS, manufactured by Siemens Healthcare Diagnostics. The device is a Class 2 Hematology device with product code GKZ cleared through the Traditional 510(k) pathway after a 532-day FDA review.

K090346 · Siemens Healthcare Diagnostics · Hematology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2010
Decision
532d
Days
Class 2
Risk

K090346 is an FDA 510(k) clearance for the ADVIA 2120/2120I BODY FLUIDS. Classified as Counter, Differential Cell (product code GKZ), Class II - Special Controls.

Submitted by Siemens Healthcare Diagnostics (Tarrytown, US). The FDA issued a Cleared decision on July 28, 2010 after a review of 532 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 Siemens Healthcare Diagnostics devices

FDA 510(k) Submission Details - K090346

510(k) Number K090346 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 11, 2009
Decision Date July 28, 2010
Days to Decision 532 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
419d slower than avg
Panel avg: 113d · This submission: 532d
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 226
Devices cleared under the same product code (GKZ) and FDA review panel - the closest regulatory comparables to K090346.
CELL-DYN EMERALD 22 SYSTEM
K110381 · Abbott Laboratories · Dec 2011
ADVIA 2120 WITH AUTOSLIDE SYSTEM, AND ADVIA 2120I
K102644 · Siemens Healthcare Diagnostics · Nov 2011
BD FACS SAMPLE PREP ASSISTANT III (SPA III)
K102064 · Becton, Dickinson & CO · Mar 2011
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
THERMO SCIENTIFIC CYTO-CAL COUNT TUBES
K090810 · Microgenics Corp. · Sep 2009