Cleared Traditional

K961311 - HEMOCUE B-GLUCOSE SYSTEM

K961311 is an FDA 510(k) clearance for HEMOCUE B-GLUCOSE SYSTEM, manufactured by Hemocue, Inc.. The device is a Class 2 Chemistry device with product code LFR cleared through the Traditional 510(k) pathway after a 141-day FDA review.

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

FDA 510(k) Submission Details - K961311

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
Combination Product No
PCCP Authorized No
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.

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 69
Devices cleared under the same product code (LFR) and FDA review panel - the closest regulatory comparables to K961311.
ACCU-CHEK(R)COMPLETE SYSTEM/METER & ACCU-CHEK ADVANTAGE TEST STRIPS/ACCU-CHEK ADVANTAGE H TEST STRIPS
K973662 · Boehringer Mannheim Corp. · Dec 1997
GLUCOTREND BASIC SYSTEM
K972876 · Boehringer Mannheim Corp. · Oct 1997
HEMOCUE B-GLCOSE SYSTEM
K962415 · Hemocue, Inc. · Oct 1996
ACCU-CHEK ADVANTAGE TEST STRIPS
K954833 · Boehringer Mannheim Corp. · Feb 1996
GLUCOSE TEST ITEM NUMBER 97375/94
K951750 · Emd Chemicals, Inc. · Sep 1995
ADVANTAGE TEST STRIPS
K951887 · Boehringer Mannheim Corp. · Aug 1995