Cleared Traditional

K850258 - BCS POTASSIUM TURBIDIMETRIC TEST

K850258 is the FDA 510(k) clearance for BCS POTASSIUM TURBIDIMETRIC TEST by Bioclinical Systems, Inc.. It is a Class 2 Chemistry device (product code CEJ) cleared through the Traditional 510(k) pathway after a 16-day FDA review.

K850258 · Bioclinical Systems, Inc. · Chemistry device
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Feb 1985
Decision
16d
Days
Class 2
Risk

K850258 is an FDA 510(k) clearance for the BCS POTASSIUM TURBIDIMETRIC TEST. Classified as Tetraphenyl Borate, Colorimetry, Potassium (product code CEJ), Class II - Special Controls.

Submitted by Bioclinical Systems, Inc. (St.Louis, US). The FDA issued a Cleared decision on February 7, 1985 after a review of 16 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 Bioclinical Systems, Inc. devices

Submission Details

510(k) Number K850258 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 22, 1985
Decision Date February 07, 1985
Days to Decision 16 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
72d faster than avg
Panel avg: 88d · This submission: 16d
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 12
Devices cleared under the same product code (CEJ) and FDA review panel - the closest regulatory comparables to K850258.
POTASSIUM TEST
K863486 · Sclavo, Inc. · Sep 1986
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
POTASSIUM TEST
K811661 · King Diagnostics, Inc. · Jun 1981