Cleared Traditional

K884736 - GLUCOSE-HK TEST (GLUC-HK) ITEM #65665

K884736 is the FDA 510(k) clearance for GLUCOSE-HK TEST (GLUC-HK) ITEM #65665 by Em Diagnostic Systems, Inc.. It is a Class 2 Chemistry device (product code CFR) cleared through the Traditional 510(k) pathway after a 50-day FDA review.

K884736 · Em Diagnostic Systems, Inc. · Chemistry device
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Jan 1989
Decision
50d
Days
Class 2
Risk

K884736 is an FDA 510(k) clearance for the GLUCOSE-HK TEST (GLUC-HK) ITEM #65665. Classified as Hexokinase, Glucose (product code CFR), Class II - Special Controls.

Submitted by Em Diagnostic Systems, Inc. (Gibbstown, US). The FDA issued a Cleared decision on January 3, 1989 after a review of 50 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 Em Diagnostic Systems, Inc. devices

Submission Details

510(k) Number K884736 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 14, 1988
Decision Date January 03, 1989
Days to Decision 50 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
38d faster than avg
Panel avg: 88d · This submission: 50d
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 K884736.
ABBOTT SPECTRUM GLUCOSE-HEXOKINASE REAGENT
K894394 · Abbott Laboratories · Oct 1989
GLUCOSE-HK TEST (GLU-HK) ITEM #65415
K894483 · Em Diagnostic Systems, Inc. · Sep 1989
AMRESCO PRODUCT NUMBER 7426
K891923 · American Research Products Co. · Jun 1989
EMDS GLUCOSE (GLUC) TESTPACKS, NO. 67697/95
K884021 · Em Diagnostic Systems, Inc. · Nov 1988
ABBOTT SPECTRUM SIMULSTAT GLUCOSE/BUN REAGENT
K882334 · Abbott Laboratories · Aug 1988
GLUCOSE (HEXOKINASE)
K874846 · Tech-Co, Inc. · Mar 1988