Cleared Traditional

K821198 - DIRECT GLUCOSE REAGENT SET

K821198 is the FDA 510(k) clearance for DIRECT GLUCOSE REAGENT SET by Omega Medical Electronics. It is a Class 2 Chemistry device (product code CGE) cleared through the Traditional 510(k) pathway after a 77-day FDA review.

K821198 · Omega Medical Electronics · Chemistry device
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Jul 1982
Decision
77d
Days
Class 2
Risk

K821198 is an FDA 510(k) clearance for the DIRECT GLUCOSE REAGENT SET. Classified as Orthotoluidine, Glucose (product code CGE), Class II - Special Controls.

Submitted by Omega Medical Electronics (Mchenry, US). The FDA issued a Cleared decision on July 13, 1982 after a review of 77 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 K821198 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 27, 1982
Decision Date July 13, 1982
Days to Decision 77 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
11d faster than avg
Panel avg: 88d · This submission: 77d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code CGE Orthotoluidine, 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 - CGE Orthotoluidine, Glucose

All 7
Devices cleared under the same product code (CGE) and FDA review panel - the closest regulatory comparables to K821198.
SODIUM HYDROXIDE SOLUTION, CREATININE REAG./DILU.
K890335 · Alpkem Corp. · Feb 1989
DIRECT GLUCOSE REAGENT SET
K841054 · Medical Specialties, Inc. · May 1984
KING DIAGNOSTICS GLUCOSE-O TEST
K811883 · King Diagnostics, Inc. · Jul 1981
ORTHO-TOLUIDINE REAGENT SET
K790319 · Fisher Scientific Co., LLC · Mar 1979
GLUCOSE REAGENT (O-TOLUIDINE)
K771314 · Mallinckrodt Critical Care · Aug 1977
UNIPAK GLUCOSE
K771091 · Harleco · Jul 1977