Cleared Traditional

POTASSIUM QVET (K943026) - FDA 510(k) Clearance

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

K943026 · Prisma Systems · Chemistry device
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Dec 1994
Decision
165d
Days
Class 2
Risk

K943026 is an FDA 510(k) clearance for the POTASSIUM QVET. Classified as Tetraphenyl Borate, Colorimetry, Potassium (product code CEJ), Class II - Special Controls.

Submitted by Prisma Systems (Rome, US). The FDA issued a Cleared decision on December 9, 1994 after a review of 165 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Chemistry review framework, consistent with the majority of Class II 510(k) submissions.

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Submission Details

510(k) Number K943026 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 27, 1994
Decision Date December 09, 1994
Days to Decision 165 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
77d slower than avg
Panel avg: 88d · This submission: 165d
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 K943026.
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