Cleared Traditional

K031898 - EKF DIAGNOSTIC HEMO CONTROL HEMOGLOBIN MEASUREMENT SYSTEM

K031898 is an FDA 510(k) clearance for EKF DIAGNOSTIC HEMO CONTROL HEMOGLOBIN ..., manufactured by Ekf Diagnostic GmbH. The device is a Class 2 Hematology device with 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.

FDA 510(k) Submission Details - K031898

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
Combination Product No
PCCP Authorized No
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.

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 36
Devices cleared under the same product code (GKR) and FDA review panel - the closest regulatory comparables to K031898.
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
STANBIO LABORATORY HEMOPOINT H2 HEMOGLOBIN MEASUREMENT SYSTEM
K032482 · Stanbio Laboratory · Oct 2003
HEMOCUE HEMOGLOBIN 201 + SYSTEM ARTICLE 121704
K032203 · Hemocue, Inc. · Aug 2003
ITC HGB PRO PROFESSIONAL HEMOGLOBIN TESTING SYSTEM
K023561 · International Technidyne Corp. · Jan 2003
BIOTEST HEMOGLOBIN MEASURING SYSTEM
K020710 · Biotest Medizintechnik GmbH · Aug 2002
K031898 · EKF DIAGNOSTIC HEMO CONTROL HEMOGLOBIN MEASUREMENT SYSTEM
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