Cleared Traditional

K821204 - GLUCOSE(ENZYMATIC) REAGENT SET

K821204 is the FDA 510(k) clearance for GLUCOSE(ENZYMATIC) REAGENT SET by Omega Medical Electronics. It is a Class 2 Chemistry device (product code CGA) cleared through the Traditional 510(k) pathway after a 86-day FDA review.

K821204 · Omega Medical Electronics · Chemistry device
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Jul 1982
Decision
86d
Days
Class 2
Risk

K821204 is an FDA 510(k) clearance for the GLUCOSE(ENZYMATIC) REAGENT SET. Classified as Glucose Oxidase, Glucose (product code CGA), Class II - Special Controls.

Submitted by Omega Medical Electronics (Mchenry, US). The FDA issued a Cleared decision on July 22, 1982 after a review of 86 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 Omega Medical Electronics devices

Submission Details

510(k) Number K821204 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 27, 1982
Decision Date July 22, 1982
Days to Decision 86 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
2d faster than avg
Panel avg: 88d · This submission: 86d
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 Chemistry devices follow this clearance model.

Regulatory Peers - CGA Glucose Oxidase, Glucose

All 198
Devices cleared under the same product code (CGA) and FDA review panel - the closest regulatory comparables to K821204.
GLUCOSCAN METER MODEL II
K822699 · Lifescan, Inc. · Nov 1982
LANCER MSH GLUCOSE DIAG. KIT
K822958 · Sherwood Medical Co. · Nov 1982
GLUCOSCAN TEST STRIPS
K822697 · Lifescan, Inc. · Sep 1982
ACCUDEX REAGENT STRIPS
K821247 · Miles Laboratories, Inc. · May 1982
VISIDEX REAGENT STRIPS
K821179 · Miles Laboratories, Inc. · May 1982
ELECTROLYTE GEL
K813370 · Hi Chem, Inc. · Dec 1981