Cleared Special

K041230 - CLINICAL LABORATORY ANALYZING SYSTEM

K041230 is an FDA 510(k) clearance for CLINICAL LABORATORY ANALYZING SYSTEM, manufactured by Hemocue, Inc.. The device is a Class 2 Chemistry device with product code LFR cleared through the Special 510(k) pathway after a 10-day FDA review.

K041230 · Hemocue, Inc. · Chemistry device
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May 2004
Decision
10d
Days
Class 2
Risk

K041230 is an FDA 510(k) clearance for the CLINICAL LABORATORY ANALYZING SYSTEM. Classified as Glucose Dehydrogenase, Glucose (product code LFR), Class II - Special Controls.

Submitted by Hemocue, Inc. (Potomac, US). The FDA issued a Cleared decision on May 20, 2004 after a review of 10 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1345 - the FDA in vitro diagnostics and chemistry 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. Low regulatory complexity profile. 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 - K041230

510(k) Number K041230 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 10, 2004
Decision Date May 20, 2004
Days to Decision 10 days
Submission Type Special
Review Panel Chemistry (CH)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
79d faster than avg
Panel avg: 89d · This submission: 10d
Pathway characteristics
Modification to existing cleared device.

LFR Device Classification - Class 2, Special Controls

Product Code LFR Glucose Dehydrogenase, Glucose
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1345
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 Chemistry devices follow this clearance model.

Regulatory Peers - LFR Glucose Dehydrogenase, Glucose

All 72
Devices cleared under the same product code (LFR) and FDA review panel - the closest regulatory comparables to K041230.
MODIFICATION TO ACCU-CHEK GO SYSTEM
K051592 · Roche Diagnostics Corp. · Sep 2005
ACCU-CHEK INTEGRA SYSTEM
K050872 · Roche Diagnostics Corp. · May 2005
ACCU-CHEK AVIVA SYSTEM
K043474 · Roche Diagnostics Corp. · Apr 2005
ACCU-CHEK GO SYSTEM
K040796 · Roche Diagnostics Corp. · Apr 2004
SENOVA(R) BLOOD GLUCOSE MONITOR
K032076 · Chdiagnostics, LLC · Sep 2003
ACCU-CHEK COMPACT TEST STRIP
K031755 · Roche Diagnostics Corp. · Jul 2003
K041230 · CLINICAL LABORATORY ANALYZING SYSTEM
Download PDF Hemocue, Inc.