Cleared Special

K090093 - STANBIO LABORATORY HEMOPOINT H2 DM HEMO...

K090093 is the FDA 510(k) clearance for STANBIO LABORATORY HEMOPOINT H2 DM HEMO... by Stanbio Laboratory. It is a Class 2 Hematology device (product code GKR) cleared through the Special 510(k) pathway after a 147-day FDA review.

K090093 · Stanbio Laboratory · Hematology device
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Jun 2009
Decision
147d
Days
Class 2
Risk

K090093 is an FDA 510(k) clearance for the STANBIO LABORATORY HEMOPOINT H2 DM HEMOGLOBIN MEASUREMENT SYSTEM. Classified as System, Hemoglobin, Automated (product code GKR), Class II - Special Controls.

Submitted by Stanbio Laboratory (Boerne, US). The FDA issued a Cleared decision on June 10, 2009 after a review of 147 days - within the typical 510(k) review window.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 864.5620 - the FDA hematology device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Stanbio Laboratory devices

Submission Details

510(k) Number K090093 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 14, 2009
Decision Date June 10, 2009
Days to Decision 147 days
Submission Type Special
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
34d slower than avg
Panel avg: 113d · This submission: 147d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code GKR System, Hemoglobin, Automated
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 864.5620
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 - GKR System, Hemoglobin, Automated

All 16
Devices cleared under the same product code (GKR) and FDA review panel - the closest regulatory comparables to K090093.
hemochroma PLUS System
K182298 · Immunostics Inc., · Nov 2018
DiaSpect Tm, DiaSpect Tm Cuvettes
K172173 · Ekf Diagnostic GmbH · Apr 2018
MISSION PLUS HB HEMOGLOBIN TESTING SYSTEM
K122553 · ACON Laboratories, Inc. · Aug 2013
STANBIO LABORATORY HEMOPOINT H2 HEMOGLOBIN MEASUREMENT SYSTEM
K081719 · Stanbio Laboratory · Jul 2008
STANBIO LABORATORY HEMOPOINT H2 HEMOGLOBIN MEASUREMENT SYSTEM
K032482 · Stanbio Laboratory · Oct 2003
ITC HGB PRO PROFESSIONAL HEMOGLOBIN TESTING SYSTEM
K023561 · International Technidyne Corp. · Jan 2003