Cleared Traditional

K792398 - ELVI GLUCOSE

K792398 is an FDA 510(k) clearance for ELVI GLUCOSE, manufactured by Volu Sol Medical Industries. 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.

K792398 · Volu Sol Medical Industries · Chemistry device
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Dec 1979
Decision
11d
Days
Class 2
Risk

K792398 is an FDA 510(k) clearance for the ELVI GLUCOSE. Classified as Glucose Oxidase, Glucose (product code CGA), Class II - Special Controls.

Submitted by Volu Sol Medical Industries (Mchenry, US). The FDA issued a Cleared decision on December 7, 1979 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 Volu Sol Medical Industries devices

FDA 510(k) Submission Details - K792398

510(k) Number K792398 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 26, 1979
Decision Date December 07, 1979
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 302
Devices cleared under the same product code (CGA) and FDA review panel - the closest regulatory comparables to K792398.
LINEAR ENZYMATIC GLUCOSE SYSTEM
K800200 · Simmler, Inc. · Feb 1980
GLUCOSE OXIDASE REAGENT KIT
K800070 · Fisher Scientific Co., LLC · Feb 1980
NEOCHROME II GLUCOSE, #4044
K792534 · American Monitor Corp. · Jan 1980
TECHNICON C202 SYSTEM
K791989 · Technicon Instruments Corp. · Oct 1979
GLUCOSE OXIDASE REAGENT SET
K791669 · Macomb Chemical Co. · Sep 1979
GLUCOSE REAGENT
K791685 · Hi Chem, Inc. · Sep 1979