Cleared Traditional

K880236 - GLUCOSE HEXOKINASE

K880236 is an FDA 510(k) clearance for GLUCOSE HEXOKINASE, manufactured by Tech-Neal Scientific, Inc.. The device is a Class 2 Chemistry device with product code CFR cleared through the Traditional 510(k) pathway after a 55-day FDA review.

K880236 · Tech-Neal Scientific, Inc. · Chemistry device
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Mar 1988
Decision
55d
Days
Class 2
Risk

K880236 is an FDA 510(k) clearance for the GLUCOSE HEXOKINASE. Classified as Hexokinase, Glucose (product code CFR), Class II - Special Controls.

Submitted by Tech-Neal Scientific, Inc. (Westmont, US). The FDA issued a Cleared decision on March 15, 1988 after a review of 55 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 Tech-Neal Scientific, Inc. devices

FDA 510(k) Submission Details - K880236

510(k) Number K880236 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 20, 1988
Decision Date March 15, 1988
Days to Decision 55 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
33d faster than avg
Panel avg: 88d · This submission: 55d
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 135
Devices cleared under the same product code (CFR) and FDA review panel - the closest regulatory comparables to K880236.
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K882334 · Abbott Laboratories · Aug 1988
GLUCOSE (HEXOKINASE)
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K873835 · Intersect Systems, Inc. · Nov 1987
MODIFIED PARAMAX GLUCOSE REAGENT
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