Cleared Traditional

K953210 - GLUCOSE (HEXOKINASE) KIT

K953210 is the FDA 510(k) clearance for GLUCOSE (HEXOKINASE) KIT by Randox Laboratories, Ltd.. It is a Class 2 Chemistry device (product code CFR) cleared through the Traditional 510(k) pathway after a 473-day FDA review.

K953210 · Randox Laboratories, Ltd. · Chemistry device
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Oct 1996
Decision
473d
Days
Class 2
Risk

K953210 is an FDA 510(k) clearance for the GLUCOSE (HEXOKINASE) KIT. Classified as Hexokinase, Glucose (product code CFR), Class II - Special Controls.

Submitted by Randox Laboratories, Ltd. (Crumlin, IE). The FDA issued a Cleared decision on October 25, 1996 after a review of 473 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Chemistry submissions.

View all Randox Laboratories, Ltd. devices

Submission Details

510(k) Number K953210 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 10, 1995
Decision Date October 25, 1996
Days to Decision 473 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
385d slower than avg
Panel avg: 88d · This submission: 473d
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 K953210.
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
GLUCOSE-SL ASSAY, CATALOGUE NO. 235-60
K961282 · Diagnostic Chemicals , Ltd. · Jun 1996
HICHEM GLUCOSE/HK REAGENT KIT
K960084 · Hi Chem, Inc. · Apr 1996
ROCHE REAGENT FOR GLUCOSE
K953847 · Roche Diagnostic Systems, Inc. · Feb 1996