Cleared Traditional

K780093 - GLUCOSE REAGENT FOR GLUCOSE ANALYZER

K780093 is the FDA 510(k) clearance for GLUCOSE REAGENT FOR GLUCOSE ANALYZER by Harleco. It is a Class 2 Chemistry device (product code CGA) cleared through the Traditional 510(k) pathway after a 26-day FDA review.

K780093 · Harleco · Chemistry device
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Feb 1978
Decision
26d
Days
Class 2
Risk

K780093 is an FDA 510(k) clearance for the GLUCOSE REAGENT FOR GLUCOSE ANALYZER. Classified as Glucose Oxidase, Glucose (product code CGA), Class II - Special Controls.

Submitted by Harleco (Mchenry, US). The FDA issued a Cleared decision on February 13, 1978 after a review of 26 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 Harleco devices

Submission Details

510(k) Number K780093 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 18, 1978
Decision Date February 13, 1978
Days to Decision 26 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
62d faster than avg
Panel avg: 88d · This submission: 26d
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 191
Devices cleared under the same product code (CGA) and FDA review panel - the closest regulatory comparables to K780093.
STATTEK-GLUCOSE LOW LEVEL
K781075 · Boehringer Mannheim Corp. · Aug 1978
BIOSTATOR GLUCOSE ANALYZER
K780393 · Miles Laboratories, Inc. · Jun 1978
AUTOZYME GLUCOSE OXIDASE (TRINDER)
K772308 · J.T. Baker Chemical Co. · Mar 1978
GLUCOSE REAGENT FOR GLUC. ANALYZER
K771754 · Harleco · Oct 1977
MULTISTAT III GLUCOSE TEST
K771471 · Instrumentation Laboratory CO · Sep 1977
DIAG. OZYRATE GLUCOSE REAG. SET
K771059 · J.T. Baker Chemical Co. · Jul 1977