Cleared Traditional

K850930 - GLUCOSE

K850930 is the FDA 510(k) clearance for GLUCOSE by Dilab, Inc.. It is a Class 2 Chemistry device (product code CGE) cleared through the Traditional 510(k) pathway after a 95-day FDA review.

K850930 · Dilab, Inc. · Chemistry device
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Jun 1985
Decision
95d
Days
Class 2
Risk

K850930 is an FDA 510(k) clearance for the GLUCOSE. Classified as Orthotoluidine, Glucose (product code CGE), Class II - Special Controls.

Submitted by Dilab, Inc. (Miami, US). The FDA issued a Cleared decision on June 10, 1985 after a review of 95 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Chemistry review framework, consistent with the majority of Class II 510(k) submissions.

View all Dilab, Inc. devices

Submission Details

510(k) Number K850930 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 07, 1985
Decision Date June 10, 1985
Days to Decision 95 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
7d slower than avg
Panel avg: 88d · This submission: 95d
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

Devices cleared under the same product code (CGE) and FDA review panel - the closest regulatory comparables to K850930.
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