Cleared Traditional

HEMOCUE B-GLUCOSE SYSTEM (K961311) - FDA 510(k) Clearance

Class II Chemistry device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K961311 · Hemocue, Inc. · Chemistry device
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Aug 1996
Decision
141d
Days
Class 2
Risk

K961311 is an FDA 510(k) clearance for the HEMOCUE B-GLUCOSE 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 August 23, 1996 after a review of 141 days - within the typical 510(k) review window.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1345 - the FDA in vitro diagnostics and chemistry 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 Chemistry review framework, consistent with the majority of Class II 510(k) submissions.

View all Hemocue, Inc. devices

Submission Details

510(k) Number K961311 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 04, 1996
Decision Date August 23, 1996
Days to Decision 141 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
53d slower than avg
Panel avg: 88d · This submission: 141d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 K961311.
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ACCU-CHEK INTEGRA SYSTEM
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ACCU-CHEK AVIVA SYSTEM
K043474 · Roche Diagnostics Corp. · Apr 2005
ACCU-CHEK GO SYSTEM
K040796 · Roche Diagnostics Corp. · Apr 2004
ACCU-CHEK COMPACT TEST STRIP
K031755 · Roche Diagnostics Corp. · Jul 2003