Cleared Abbreviated

K020710 - BIOTEST HEMOGLOBIN MEASURING SYSTEM

K020710 is an FDA 510(k) clearance for BIOTEST HEMOGLOBIN MEASURING SYSTEM, manufactured by Biotest Medizintechnik GmbH. The device is a Class 2 Hematology device with product code GKR cleared through the Abbreviated 510(k) pathway after a 162-day FDA review.

K020710 · Biotest Medizintechnik GmbH · Hematology device
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Aug 2002
Decision
162d
Days
Class 2
Risk

K020710 is an FDA 510(k) clearance for the BIOTEST HEMOGLOBIN MEASURING SYSTEM. Classified as System, Hemoglobin, Automated (product code GKR), Class II - Special Controls.

Submitted by Biotest Medizintechnik GmbH (Richmond, US). The FDA issued a Cleared decision on August 14, 2002 after a review of 162 days - an extended review cycle.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 864.5620 - the FDA hematology device framework. The Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

View all Biotest Medizintechnik GmbH devices

FDA 510(k) Submission Details - K020710

510(k) Number K020710 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 05, 2002
Decision Date August 14, 2002
Days to Decision 162 days
Submission Type Abbreviated
Review Panel Hematology (HE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
49d slower than avg
Panel avg: 113d · This submission: 162d
Pathway characteristics
Standards-based clearance path.

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 30
Devices cleared under the same product code (GKR) and FDA review panel - the closest regulatory comparables to K020710.
HEMOCUE HEMOGLOBIN 201DM ANALYZING SYSTEM
K041234 · Hemocue, Inc. · Jun 2004
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
BAYER RAPIDPOINT 405 SYSTEM
K020616 · Bayer Diagnostics Corp. · Jul 2002
HEMOCUE B-HEMOGLOBIN SYSTEM
K961312 · Hemocue, Inc. · Sep 1996
IL682, CO-OXIMETER
K945677 · Instrumentation Laboratory CO · Oct 1995