Cleared Traditional

K031898 - EKF DIAGNOSTIC HEMO CONTROL HEMOGLOBIN ...

K031898 is the FDA 510(k) clearance for EKF DIAGNOSTIC HEMO CONTROL HEMOGLOBIN ... by Ekf Diagnostic GmbH. It is a Class 2 Hematology device (product code GKR) cleared through the Traditional 510(k) pathway after a 97-day FDA review.

K031898 · Ekf Diagnostic GmbH · Hematology device
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Sep 2003
Decision
97d
Days
Class 2
Risk

K031898 is an FDA 510(k) clearance for the EKF DIAGNOSTIC HEMO CONTROL HEMOGLOBIN MEASUREMENT SYSTEM. Classified as System, Hemoglobin, Automated (product code GKR), Class II - Special Controls.

Submitted by Ekf Diagnostic GmbH (Egale, US). The FDA issued a Cleared decision on September 24, 2003 after a review of 97 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. 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 Ekf Diagnostic GmbH devices

Submission Details

510(k) Number K031898 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 19, 2003
Decision Date September 24, 2003
Days to Decision 97 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
16d faster than avg
Panel avg: 113d · This submission: 97d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 13
Devices cleared under the same product code (GKR) and FDA review panel - the closest regulatory comparables to K031898.
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
IL682, CO-OXIMETER
K945677 · Instrumentation Laboratory CO · Oct 1995
CIBA CORNING MODEL 280 PH/BLOOD GAS SYSTEM
K880353 · Ciba Corning Diagnostics Corp. · Jun 1988
HEMESPEC II
K803015 · Helena Laboratories · Dec 1980