Cleared Traditional

K980026 - GLUCOSE (HK) - INCORPORATING DYNAMIC ST...

K980026 is the FDA 510(k) clearance for GLUCOSE (HK) - INCORPORATING DYNAMIC ST... by Trace America, Inc.. It is a Class 2 Chemistry device (product code CFR) cleared through the Traditional 510(k) pathway after a 64-day FDA review.

K980026 · Trace America, Inc. · Chemistry device
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Mar 1998
Decision
64d
Days
Class 2
Risk

K980026 is an FDA 510(k) clearance for the GLUCOSE (HK) - INCORPORATING DYNAMIC STABILIZATION TECHNOLOGY - (DST). Classified as Hexokinase, Glucose (product code CFR), Class II - Special Controls.

Submitted by Trace America, Inc. (Miami, US). The FDA issued a Cleared decision on March 10, 1998 after a review of 64 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 Trace America, Inc. devices

Submission Details

510(k) Number K980026 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 05, 1998
Decision Date March 10, 1998
Days to Decision 64 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
24d faster than avg
Panel avg: 88d · This submission: 64d
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 108
Devices cleared under the same product code (CFR) and FDA review panel - the closest regulatory comparables to K980026.
GLUCOSE (HEXOKINASE) LIQUID REAGENT, MODEL G518-150
K000102 · Teco Diagnostics · Feb 2000
INFINITY GLUCOSE REAGENT
K984574 · Sigma Diagnostics, Inc. · Feb 1999
GLU
K981185 · Abbott Laboratories · May 1998
LIQUID GLUCOSE (HEXOKINASE) REAGENT SET
K971754 · Pointe Scientific, Inc., · Jul 1997
GLUCOMETER ENCORE QA+ BLOOD GLUCOSE METER
K971276 · Bayer Corp. · Jun 1997
GLUCOMETER ENCORE BLOOD GLUCOSE TEST STRIPS
K964004 · Bayer Corp. · Feb 1997