Product Code: CEJ FDA class 2 21 CFR 862.1600

Tetraphenyl Borate, Colorimetry, Potassium

Clinical Chemistry

The Tetraphenyl Borate Colorimetry Potassium Test is a clinical chemistry device that measures potassium concentration in biological samples by precipitation with tetraphenylborate followed by colorimetric quantification of the resulting turbidity, used in electrolyte analysis and the diagnosis of hypokalemia or hyperkalemia. It is classified as FDA Class 2 (moderate risk), requiring 510(k) premarket notification. The product code is CEJ, regulated under 21 CFR 862.1600, within the Clinical Chemistry medical specialty. This device is eligible for third-party review.

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510(k)s

FEI Numbers

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Basic Information

Product Code: CEJ
Device Class: FDA class 2
Regulation Number: 862.1600
Medical Specialty: Clinical Chemistry
Review Panel: CH
Submission Type: 1

Device Characteristics

✗

GMP Exempt

✗

Implant

✗

Life Sustain/Support

✓

Third Party

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Summary Malfunction Reporting

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 16 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K043267	POTASSIUM TEST KIT AND ELECTROLYTE CAL 1 AND 2	Feb 10, 2005	Substantially Equivalent	Randox Laboratories, Ltd.
K943026	POTASSIUM QVET	Dec 09, 1994	Substantially Equivalent	Prisma Systems
K904033	REFLOTRON POTASSIUM TEST TABS	Nov 06, 1990	Substantially Equivalent	Boehringer Mannheim Corp.
K902574	POTASSIUM REAGENT SET	Jul 10, 1990	Substantially Equivalent	Tech-Co, Inc.
K883586	TECHNICON RA-100 SYSTEM POTASSIUM	Nov 29, 1988	Substantially Equivalent	Technicon Instruments Corp.
K883585	TECHNICON ASSIST POTASSIUM	Nov 29, 1988	Substantially Equivalent	Technicon Instruments Corp.
K881440	IQ POTASSIUM	May 27, 1988	Substantially Equivalent	Bd Becton Dickinson Vacutainer Systems Preanalytic
K880339	EASY-TEST POTASSIUM K ITEM NUMBER 19XXX	Feb 25, 1988	Substantially Equivalent	Em Diagnostic Systems, Inc.
K863486	POTASSIUM TEST	Sep 29, 1986	Substantially Equivalent	Sclavo, Inc.
K861713	SERUM POTASSIUM REAGENT SET	May 23, 1986	Substantially Equivalent	Sterling Diagnostics, Inc.
K853404	QCA POTASSIUM TEST KIT	Aug 23, 1985	Substantially Equivalent	Bd Becton Dickinson Vacutainer Systems Preanalytic
K850258	BCS POTASSIUM TURBIDIMETRIC TEST	Feb 07, 1985	Substantially Equivalent	Bioclinical Systems, Inc.
K832553	POTASSIUM TEST KIT	Sep 20, 1983	Substantially Equivalent	Mallinckrodt Critical Care
K813608	POTASSIUM REAGENT SET	Jan 22, 1982	Substantially Equivalent	Diagnostic Specialties
K812677	UNITEST-POTASSIUM	Oct 02, 1981	Substantially Equivalent	Biodynamics Corp.
K811661	POTASSIUM TEST	Jun 25, 1981	Substantially Equivalent	King Diagnostics, Inc.