Cleared Traditional

K912808 - ABBOTT QUICK START GLUCOSE (GLUE) ITEM#...

K912808 is the FDA 510(k) clearance for ABBOTT QUICK START GLUCOSE (GLUE) ITEM#... by Em Diagnostic Systems, Inc.. It is a Class 2 Chemistry device (product code CFR) cleared through the Traditional 510(k) pathway after a 35-day FDA review.

K912808 · Em Diagnostic Systems, Inc. · Chemistry device
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Jul 1991
Decision
35d
Days
Class 2
Risk

K912808 is an FDA 510(k) clearance for the ABBOTT QUICK START GLUCOSE (GLUE) ITEM# 5A15. 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 July 30, 1991 after a review of 35 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 K912808 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 25, 1991
Decision Date July 30, 1991
Days to Decision 35 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
53d faster than avg
Panel avg: 88d · This submission: 35d
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 K912808.
MILES URINE GLUCOSE METHOD
K923040 · Heraeus Kulzer, Inc. · Sep 1992
OLYMPUS GLUCOSE REAGENT
K922232 · Olympus Corp. · Jul 1992
TECHNICON CHEM 1 PLASMA GLUCOSE
K914794 · Heraeus Kulzer, Inc. · Dec 1991
KING DIAGNOSTICS GLUCOSE (HK) REAGENT STRIP TEST
K912251 · King Diagnostics, Inc. · Jul 1991
TECHNICON CHEM 1 CLINICAL ANALYZER URINE GLUCOSE
K901122 · Technicon Instruments Corp. · Mar 1990
COULTER GLUCOSE REAGENT
K897160 · Coulter Electronics, Inc. · Mar 1990