Cleared Traditional

K911141 - HEMOCUE(R) B-GLUCOSE MICROCUVETTE/PHOTOMETER

K911141 is an FDA 510(k) clearance for HEMOCUE B-GLUCOSE MICROCUVETTE/PHOTOMETER, manufactured by Hemocue, Inc.. The device is a Class 2 Chemistry device with product code CGA cleared through the Traditional 510(k) pathway after a 55-day FDA review.

K911141 · Hemocue, Inc. · Chemistry device
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May 1991
Decision
55d
Days
Class 2
Risk

K911141 is an FDA 510(k) clearance for the HEMOCUE(R) B-GLUCOSE MICROCUVETTE/PHOTOMETER. Classified as Glucose Oxidase, Glucose (product code CGA), Class II - Special Controls.

Submitted by Hemocue, Inc. (Potomac, US). The FDA issued a Cleared decision on May 8, 1991 after a review of 55 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

FDA 510(k) Submission Details - K911141

510(k) Number K911141 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 14, 1991
Decision Date May 08, 1991
Days to Decision 55 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
34d faster than avg
Panel avg: 89d · This submission: 55d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

CGA Device Classification - Class 2, Special Controls

Product Code CGA Glucose Oxidase, 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 - CGA Glucose Oxidase, Glucose

All 400
Devices cleared under the same product code (CGA) and FDA review panel - the closest regulatory comparables to K911141.
ULTRA BLOOD GLUCOSE MONITORING SYSTEM
K912440 · Home Diagnostics, Inc. · Jul 1991
VISION BG MONITOR
K911596 · British-American Medical, Inc. · May 1991
FIRST CHOICE(TM), MODIFICATION
K911792 · Polymer Technology Corp. · May 1991
YSI MODEL 1500 BLOOD GLUCOSE ANALYZER
K910633 · Yellow Springs Instrument Co., Inc. · Apr 1991
GLUCOSE V
K910573 · Caro Med, Inc. · Apr 1991
BIO SCAN-BG(TM
K910692 · Bio Scan Instrument, Inc. · Mar 1991
K911141 · HEMOCUE(R) B-GLUCOSE MICROCUVETTE/PHOTOMETER
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