Cleared Traditional

K863486 - POTASSIUM TEST

K863486 is the FDA 510(k) clearance for POTASSIUM TEST by Sclavo, Inc.. It is a Class 2 Chemistry device (product code CEJ) cleared through the Traditional 510(k) pathway after a 20-day FDA review.

K863486 · Sclavo, Inc. · Chemistry device
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Sep 1986
Decision
20d
Days
Class 2
Risk

K863486 is an FDA 510(k) clearance for the POTASSIUM TEST. Classified as Tetraphenyl Borate, Colorimetry, Potassium (product code CEJ), Class II - Special Controls.

Submitted by Sclavo, Inc. (Wayne, US). The FDA issued a Cleared decision on September 29, 1986 after a review of 20 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 Sclavo, Inc. devices

Submission Details

510(k) Number K863486 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 09, 1986
Decision Date September 29, 1986
Days to Decision 20 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
68d faster than avg
Panel avg: 88d · This submission: 20d
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 11
Devices cleared under the same product code (CEJ) and FDA review panel - the closest regulatory comparables to K863486.
TECHNICON RA-100 SYSTEM POTASSIUM
K883586 · Technicon Instruments Corp. · Nov 1988
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
SERUM POTASSIUM REAGENT SET
K861713 · Sterling Diagnostics, Inc. · May 1986
QCA POTASSIUM TEST KIT
K853404 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Aug 1985
POTASSIUM TEST KIT
K832553 · Mallinckrodt Critical Care · Sep 1983