Cleared Traditional

K761181 - GLUCOSE OXIDASE REAGENT SYSTEM

K761181 is an FDA 510(k) clearance for GLUCOSE OXIDASE REAGENT SYSTEM, manufactured by Nobel Scientific Industries, Inc.. The device is a Class 2 Chemistry device with product code CGA cleared through the Traditional 510(k) pathway after a 11-day FDA review.

K761181 · Nobel Scientific Industries, Inc. · Chemistry device
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Dec 1976
Decision
11d
Days
Class 2
Risk

K761181 is an FDA 510(k) clearance for the GLUCOSE OXIDASE REAGENT SYSTEM. Classified as Glucose Oxidase, Glucose (product code CGA), Class II - Special Controls.

Submitted by Nobel Scientific Industries, Inc. (Mchenry, US). The FDA issued a Cleared decision on December 13, 1976 after a review of 11 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.

View all Nobel Scientific Industries, Inc. devices

FDA 510(k) Submission Details - K761181

510(k) Number K761181 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 02, 1976
Decision Date December 13, 1976
Days to Decision 11 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
77d faster than avg
Panel avg: 88d · This submission: 11d
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 305
Devices cleared under the same product code (CGA) and FDA review panel - the closest regulatory comparables to K761181.
GO/HPO-GLUCOSE REAGENT (TRINDER)
K770200 · Beckman Instruments, Inc. · Feb 1977
REFLOMAT/REFLOTEST SYSTEM
K761148 · Boehringer Mannheim Corp. · Feb 1977
GLUCOSE ANALYZER 2
K761060 · Beckman Instruments, Inc. · Jan 1977
GLUC OPAP, IN VITRO DIAG. FOR GLUCOSE
K761153 · Advanced Biomedical Methods, Inc. · Dec 1976
GLUCOSE OXIDASE REAG FOR BECKMAN ANALYZ
K761154 · Advanced Biomedical Methods, Inc. · Dec 1976