Cleared Traditional

K810674 - GLUCOSE OXIDASE

K810674 is the FDA 510(k) clearance for GLUCOSE OXIDASE by Pointe Scientific, Inc.,. It is a Class 2 Toxicology device (product code CGA) cleared through the Traditional 510(k) pathway after a 19-day FDA review.

K810674 · Pointe Scientific, Inc., · Toxicology device
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Mar 1981
Decision
19d
Days
Class 2
Risk

K810674 is an FDA 510(k) clearance for the GLUCOSE OXIDASE. Classified as Glucose Oxidase, Glucose (product code CGA), Class II - Special Controls.

Submitted by Pointe Scientific, Inc., (Mchenry, US). The FDA issued a Cleared decision on March 31, 1981 after a review of 19 days - a notably fast clearance cycle.

This device falls under the Toxicology FDA review panel, regulated under 21 CFR 862.1345 - the FDA toxicology device 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 Pointe Scientific, Inc., devices

Submission Details

510(k) Number K810674 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 12, 1981
Decision Date March 31, 1981
Days to Decision 19 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
68d faster than avg
Panel avg: 87d · This submission: 19d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 Toxicology devices follow this clearance model.

Regulatory Peers - CGA Glucose Oxidase, Glucose

All 190
Devices cleared under the same product code (CGA) and FDA review panel - the closest regulatory comparables to K810674.
GLUCOSCAN TEST STRIPS
K810993 · Lifescan, Inc. · Apr 1981
GLUCOSE REAGENT-ENZYMATIC-COLOR 500
K811074 · Reagents Applications, Inc. · Apr 1981
SERALYZER SYSTEM
K810639 · Miles Laboratories, Inc. · Mar 1981
GLUCOSE (TRINDER) REAGENT
K801600 · Gilford Diagnostics · Aug 1980
SERALYZER GLUCOSE REAGENT STRIPS
K801663 · Miles Laboratories, Inc. · Aug 1980
LANCER GLUCOSE RATE REAGENT KIT
K801071 · Sherwood Medical Industries · May 1980