Cleared Traditional

K971754 - LIQUID GLUCOSE (HEXOKINASE) REAGENT SET

K971754 is an FDA 510(k) clearance for LIQUID GLUCOSE (HEXOKINASE) REAGENT SET, manufactured by Pointe Scientific, Inc.,. The device is a Class 2 Chemistry device with product code CFR cleared through the Traditional 510(k) pathway after a 71-day FDA review.

K971754 · Pointe Scientific, Inc., · Chemistry device
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Jul 1997
Decision
71d
Days
Class 2
Risk

K971754 is an FDA 510(k) clearance for the LIQUID GLUCOSE (HEXOKINASE) REAGENT SET. Classified as Hexokinase, Glucose (product code CFR), Class II - Special Controls.

Submitted by Pointe Scientific, Inc., (Lincoln Park, US). The FDA issued a Cleared decision on July 22, 1997 after a review of 71 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 Pointe Scientific, Inc., devices

FDA 510(k) Submission Details - K971754

510(k) Number K971754 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 12, 1997
Decision Date July 22, 1997
Days to Decision 71 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
17d faster than avg
Panel avg: 88d · This submission: 71d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

CFR Device Classification - Class 2, Special Controls

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 136
Devices cleared under the same product code (CFR) and FDA review panel - the closest regulatory comparables to K971754.
GLU
K981185 · Abbott Laboratories · May 1998
GLUCOSE (HK) - INCORPORATING DYNAMIC STABILIZATION TECHNOLOGY - (DST)
K980026 · Trace America, Inc. · Mar 1998
GLUCOSE REAGENT
K970664 · Derma Media Lab., Inc. · Aug 1997
GLUCOMETER ENCORE QA+ BLOOD GLUCOSE METER
K971276 · Bayer Corp. · Jun 1997
SYNCHRON CX SYSTEMS GLUCOSE REAGENT (GLU)
K971467 · Carolina Liquid Chemistries Corp. · Jun 1997
GLUCOMETER ENCORE BLOOD GLUCOSE TEST STRIPS
K964004 · Bayer Corp. · Feb 1997