Cleared Traditional

K770886 - AUTO-ENZYMATIC GLUCOSE FOR ANALYZER

K770886 is the FDA 510(k) clearance for AUTO-ENZYMATIC GLUCOSE FOR ANALYZER by Harleco. It is a Class 2 Chemistry device (product code CFR) cleared through the Traditional 510(k) pathway after a 59-day FDA review.

K770886 · Harleco · Chemistry device
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Jul 1977
Decision
59d
Days
Class 2
Risk

K770886 is an FDA 510(k) clearance for the AUTO-ENZYMATIC GLUCOSE FOR ANALYZER. Classified as Hexokinase, Glucose (product code CFR), Class II - Special Controls.

Submitted by Harleco (Mchenry, US). The FDA issued a Cleared decision on July 14, 1977 after a review of 59 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 K770886 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 16, 1977
Decision Date July 14, 1977
Days to Decision 59 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
29d faster than avg
Panel avg: 88d · This submission: 59d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code CFR Hexokinase, 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 - CFR Hexokinase, Glucose

All 107
Devices cleared under the same product code (CFR) and FDA review panel - the closest regulatory comparables to K770886.
AUTOZYME IMMOBILIZED ENZYME COIL
K771384 · Technicon Instruments Corp. · Aug 1977
GLUCOSE REAGENT (HEXOHINASE)
K771311 · Mallinckrodt Critical Care · Aug 1977
FLUCOSE U.V. TEST KIT
K770844 · Mallinckrodt Critical Care · Jul 1977
AUTO-ENZYMATIC GLUCOSE
K770229 · Harleco · Mar 1977
GLUCOSE (HEXOKINASE) DELTA TEST ASSAY
K770262 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Feb 1977
GLUCO-HEX TM REAGENT KIT
K761345 · J.T. Baker Chemical Co. · Jan 1977