Cleared Traditional

POTASSIUM TEST KIT AND ELECTROLYTE CAL 1 AND 2 (K043267) - FDA 510(k) Clearance

Class II Chemistry device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K043267 · Randox Laboratories, Ltd. · Chemistry device
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Feb 2005
Decision
76d
Days
Class 2
Risk

K043267 is an FDA 510(k) clearance for the POTASSIUM TEST KIT AND ELECTROLYTE CAL 1 AND 2. Classified as Tetraphenyl Borate, Colorimetry, Potassium (product code CEJ), Class II - Special Controls.

Submitted by Randox Laboratories, Ltd. (Crumlin, GB). The FDA issued a Cleared decision on February 10, 2005 after a review of 76 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1600 - 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 Randox Laboratories, Ltd. devices

Submission Details

510(k) Number K043267 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 26, 2004
Decision Date February 10, 2005
Days to Decision 76 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
12d faster than avg
Panel avg: 88d · This submission: 76d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code CEJ Tetraphenyl Borate, Colorimetry, Potassium
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1600
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 - CEJ Tetraphenyl Borate, Colorimetry, Potassium

All 15
Devices cleared under the same product code (CEJ) and FDA review panel - the closest regulatory comparables to K043267.
REFLOTRON POTASSIUM TEST TABS
K904033 · Boehringer Mannheim Corp. · Nov 1990
IQ POTASSIUM
K881440 · Bd Becton Dickinson Vacutainer Systems Preanalytic · May 1988
EASY-TEST POTASSIUM K ITEM NUMBER 19XXX
K880339 · Em Diagnostic Systems, Inc. · Feb 1988
QCA POTASSIUM TEST KIT
K853404 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Aug 1985