Cleared Special

K090093 - STANBIO LABORATORY HEMOPOINT H2 DM HEMOGLOBIN MEASUREMENT SYSTEM

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

K090093 · Stanbio Laboratory · Hematology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
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.

FDA 510(k) Submission Details - K090093

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.

GKR Device Classification - Class 2, Special Controls

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 38
Devices cleared under the same product code (GKR) and FDA review panel - the closest regulatory comparables to K090093.
MISSION PLUS HB HEMOGLOBIN TESTING SYSTEM
K122553 · ACON Laboratories, Inc. · Aug 2013
AVIE TOTAL HB TEST SYSTEM
K121752 · Mec Dynamics Corp · Jan 2013
EKF- DIAGNOSTIC HEMO_CONTROL HEMOGLOBIN MEASUREMENT SYSTEM
K110393 · Ekf Diagnostic GmbH · Mar 2011
STANBIO LABORATORY HEMOPOINT H2 HEMOGLOBIN MEASUREMENT SYSTEM
K081719 · Stanbio Laboratory · Jul 2008
HEMOCUE HB 301 ANALYZER, MODEL 121804 AND MICROCUVETTES, MODEL 111801
K061047 · Hemocue AB · Jun 2006
HEMOCUE HEMOGLOBIN 201DM ANALYZING SYSTEM
K041234 · Hemocue, Inc. · Jun 2004
K090093 · STANBIO LABORATORY HEMOPOINT H2 DM HEMOGLOBIN MEASUREMENT SYSTEM
Download PDF FDA Summary Stanbio Laboratory