Cleared Traditional

K801765 - GLUCOSE REAGENT(UV-HEXOKINASE)

K801765 is the FDA 510(k) clearance for GLUCOSE REAGENT(UV-HEXOKINASE) by Reagents Applications, Inc.. It is a Class 2 Chemistry device (product code CFR) cleared through the Traditional 510(k) pathway after a 50-day FDA review.

K801765 · Reagents Applications, Inc. · Chemistry device
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Sep 1980
Decision
50d
Days
Class 2
Risk

K801765 is an FDA 510(k) clearance for the GLUCOSE REAGENT(UV-HEXOKINASE). Classified as Hexokinase, Glucose (product code CFR), Class II - Special Controls.

Submitted by Reagents Applications, Inc. (Mchenry, US). The FDA issued a Cleared decision on September 16, 1980 after a review of 50 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 Reagents Applications, Inc. devices

Submission Details

510(k) Number K801765 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 28, 1980
Decision Date September 16, 1980
Days to Decision 50 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
38d faster than avg
Panel avg: 88d · This submission: 50d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code CFR Hexokinase, 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 - CFR Hexokinase, Glucose

All 107
Devices cleared under the same product code (CFR) and FDA review panel - the closest regulatory comparables to K801765.
ESKAFLOW TEST FOR GLUCOSE
K811849 · Smithkline Diagnostics, Inc. · Jul 1981
HEXOKINASE, GLUCOSE
K802810 · Beckman Instruments, Inc. · Dec 1980
F/LS MCA APPLICATION SOFTWARE
K801456 · Instrumentation Laboratory CO · Oct 1980
DATA-ZYME GLUCOSE HEXOKINASE COLOZIMETRI
K801051 · Data Medical Associates, Inc. · May 1980
DATA-ZYME GLUCOSE HEXOKINASE UV
K801052 · Data Medical Associates, Inc. · May 1980
GLUCOSE HEXOKINASE COIL REAGENT SYSTEM
K791760 · Fisher Scientific Co., LLC · Sep 1979