Cleared Traditional

K844998 - GLUCOSE(HEXOKINASE) REAGENT SET

K844998 is the FDA 510(k) clearance for GLUCOSE(HEXOKINASE) REAGENT SET by Sterling Biochemical, Inc.. It is a Class 2 Chemistry device (product code CFR) cleared through the Traditional 510(k) pathway after a 23-day FDA review.

K844998 · Sterling Biochemical, Inc. · Chemistry device
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Jan 1985
Decision
23d
Days
Class 2
Risk

K844998 is an FDA 510(k) clearance for the GLUCOSE(HEXOKINASE) REAGENT SET. Classified as Hexokinase, Glucose (product code CFR), Class II - Special Controls.

Submitted by Sterling Biochemical, Inc. (Dearborn, US). The FDA issued a Cleared decision on January 18, 1985 after a review of 23 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 Sterling Biochemical, Inc. devices

Submission Details

510(k) Number K844998 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 26, 1984
Decision Date January 18, 1985
Days to Decision 23 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
65d faster than avg
Panel avg: 88d · This submission: 23d
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 111
Devices cleared under the same product code (CFR) and FDA review panel - the closest regulatory comparables to K844998.
GLUCOSE HK-60 ASSAY KIT CAT. #201-39
K860625 · Diagnostic Chemicals, Ltd. (Usa) · Mar 1986
GLUCOSE HEXOKINASE FOR CONTINUOUS FLOW INSTRUMENTS
K853826 · Catachem, Inc. · Sep 1985
GLUCOSE SR LIQUID STABLE REAGENT SET
K853464 · Medical Analysis Systems, Inc. · Sep 1985
PDA GLUCOSE
K843541 · Abbott Laboratories · Sep 1984
SYSTEMATE GLUCOSE 67216
K843150 · Em Diagnostic Systems, Inc. · Aug 1984
GLUCOSE ASSAY KIT-HEXOKINASE
K842510 · Diagnostic Chemicals, Ltd. (Usa) · Jul 1984