Cleared Traditional

K771311 - GLUCOSE REAGENT (HEXOHINASE)

K771311 is the FDA 510(k) clearance for GLUCOSE REAGENT (HEXOHINASE) by Mallinckrodt Critical Care. It is a Class 2 Chemistry device (product code CFR) cleared through the Traditional 510(k) pathway after a 16-day FDA review.

K771311 · Mallinckrodt Critical Care · Chemistry device
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Aug 1977
Decision
16d
Days
Class 2
Risk

K771311 is an FDA 510(k) clearance for the GLUCOSE REAGENT (HEXOHINASE). Classified as Hexokinase, Glucose (product code CFR), Class II - Special Controls.

Submitted by Mallinckrodt Critical Care (Mchenry, US). The FDA issued a Cleared decision on August 3, 1977 after a review of 16 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 Mallinckrodt Critical Care devices

Submission Details

510(k) Number K771311 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 18, 1977
Decision Date August 03, 1977
Days to Decision 16 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
72d faster than avg
Panel avg: 88d · This submission: 16d
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 110
Devices cleared under the same product code (CFR) and FDA review panel - the closest regulatory comparables to K771311.
ULTRACHEM E-GLU, MANUAL DETERM.
K780065 · Harleco · Feb 1978
MULTISTAT III GLUCOSE TEST
K771464 · Instrumentation Laboratory CO · Sep 1977
AUTOZYME IMMOBILIZED ENZYME COIL
K771384 · Technicon Instruments Corp. · Aug 1977
FLUCOSE U.V. TEST KIT
K770844 · Mallinckrodt Critical Care · Jul 1977
AUTO-ENZYMATIC GLUCOSE FOR ANALYZER
K770886 · Harleco · Jul 1977
GLUCOSE REAGENT, ENZYMATIC
K770311 · Icn Pharmaceuticals, Inc. · Mar 1977