Product Code: CKB FDA class 2 21 CFR 862.1020

Acid Phosphatase, Naphthyl Phosphate

Clinical Chemistry

The Acid Phosphatase, Naphthyl Phosphate test system (product code CKB) is an in-vitro diagnostic device used in clinical chemistry to measure acid phosphatase activity in serum using naphthyl phosphate as a chromogenic substrate under acidic conditions, with spectrophotometric detection of released naphthol. It is classified as FDA Class 2, indicating moderate risk, and requires a 510(k) premarket notification. It falls under regulation 21 CFR 862.1020 in the Clinical Chemistry medical specialty.

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Basic Information

Product Code: CKB
Device Class: FDA class 2
Regulation Number: 862.1020
Medical Specialty: Clinical Chemistry
Review Panel: CH
Submission Type: 4

Device Characteristics

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GMP Exempt

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Implant

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Life Sustain/Support

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Third Party

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Summary Malfunction Reporting

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 24 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K053612	DRI-STAT ACID PHOSPHATASE REAGENT	Apr 26, 2006	Substantially Equivalent	Beckman Coulter, Inc.
K023840	ACID PHOSPHATASE ASSAY FOR THE ADVIA 1650	Jan 07, 2003	Substantially Equivalent	Bayer Diagnostics Corp.
K991010	ACP	May 19, 1999	Substantially Equivalent	Abbott Diagnostics Mfg., Inc.
K981743	OLYMPUS AU400 CLINICAL CHEMISTRY ANALYZER	Jun 09, 1998	Substantially Equivalent	Olympus America, Inc.
K974695	COBRAS INTEGRA ACID PROSTATIC PHOSPHATASE (ACPP) COBAD INTEGRA BENZODIAZEPINES WITH B-GLUCURONIDASE (BNZGL)	May 21, 1998	Substantially Equivalent	Roche Diagnostic Systems, Inc.
K963640	OLYMPUS ACID PHOSPHATASE REAGENT	Feb 18, 1997	Substantially Equivalent	Olympus America, Inc.
K943366	IL TEST ACID PHOSPHATASE	Jan 29, 1996	Substantially Equivalent	Instrumentation Laboratory CO
K902543	ACID PHOSPHOTASE REAGENT TEST AND KIT	Sep 07, 1990	Substantially Equivalent	Crestat Diagnostics, Inc.
K902495	ACID PHOSPHATASE REAGENT SET	Jul 16, 1990	Substantially Equivalent	Tech Intl. Co.
K892393	ACID PHOSPHATASE REAGENT	Jul 20, 1989	Substantially Equivalent	Medical Analysis Systems, Inc.
K884747	TECHNICON CHEM 1 SYSTEM ACID PHOSPHATASE (TOTAL)	Jan 30, 1989	Substantially Equivalent	Technicon Instruments Corp.
K881204	ACP KINETIC TEST (ACID PHOSPHATASE TEST)	Apr 28, 1988	Substantially Equivalent	Sclavo, Inc.
K880798	ACID PHOSPHATASE REAGENT	Apr 18, 1988	Substantially Equivalent	Trace America, Inc.
K875209	ACID PHOSPHATASE (KINETIC) CAT. # 320-06	Feb 01, 1988	Substantially Equivalent	Diagnostic Chemicals, Ltd. (Usa)
K863851	ACID PHOSPHATASE (ACP) REAGENT	Oct 16, 1986	Substantially Equivalent	Sigma Diagnostics, Inc.
K861675	ACID PHOSPHATASE PROCEDURE	May 29, 1986	Substantially Equivalent	Data Medical Associates, Inc.
K854223	VES-TEC/VES-MATIC	Apr 04, 1986	Substantially Equivalent	Marvic Interpharma, Inc.
K853949	DEMAND ACID PHOSPHATASE REAGENT	Oct 16, 1985	Substantially Equivalent	Cooper Biomedical, Inc.
K850902	DATA ZYME ACID PHOSPHATASE PROCEDURE	Mar 20, 1985	Substantially Equivalent	Data Medical Associates, Inc.
K840661	PARAMAX ACID PHOSPHATASE REAGENT	Apr 04, 1984	Substantially Equivalent	American Dade
K831834	RAICHEM ACID PHASPHATASE REAGENT	Aug 26, 1983	Substantially Equivalent	Reagents Applications, Inc.
K823087	BOEHRINGER MANNEHEIM DIAG. ACID PHOSPHA	Nov 18, 1982	Substantially Equivalent	Boehringer Mannheim Corp.
K821674	SPINCHEM ACID PHOSPHATASE REAGENT	Jun 22, 1982	Substantially Equivalent	Smithkline Diagnostics, Inc.
K820975	GILCHEM ACID PHOSPHATASE REAGENT	Apr 26, 1982	Substantially Equivalent	Gilford Diagnostics