Cleared Abbreviated

BIOTEST HEMOGLOBIN MEASURING SYSTEM (K020710) - FDA 510(k) Clearance

Class II Hematology device cleared through the Abbreviated 510(k) pathway - typically does not require clinical trials.

K020710 · Biotest Medizintechnik GmbH · Hematology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

Submission Details

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.

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 38
Devices cleared under the same product code (GKR) and FDA review panel - the closest regulatory comparables to K020710.
HemoCue Hb 301 System
K201217 · Hemocue AB · Aug 2020
Hemo Control (optional Add Pack Hemo Control DM)
K200909 · Ekf Diagnostic GmbH · Jun 2020
HemoCue Hb 801 System
K181751 · Hemocue AB · Feb 2019
hemochroma PLUS System
K182298 · Immunostics Inc., · Nov 2018
DiaSpect Tm, DiaSpect Tm Cuvettes
K172173 · Ekf Diagnostic GmbH · Apr 2018
IL682, CO-OXIMETER
K945677 · Instrumentation Laboratory CO · Oct 1995