Product Code: JIQ FDA class 1 21 CFR 862.1645

Turbidimetric Method, Protein Or Albumin (Urinary, Non-Quant.)

Clinical Chemistry

This device is a clinical chemistry reagent system that uses a turbidimetric method to qualitatively or semi-quantitatively detect protein or albumin in urine, used to screen for proteinuria as an indicator of kidney dysfunction or urinary tract disease. It is classified as FDA Class 1, the lowest risk category, subject only to general controls such as proper labeling and manufacturing standards, with no premarket submission required. The product code is JIQ, regulated under 21 CFR 862.1645, and assigned to the Clinical Chemistry medical specialty.

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Basic Information

Product Code: JIQ
Device Class: FDA class 1
Regulation Number: 862.1645
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 13 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K141925	TOTAL PROTEIN URINE/CSF GEN.3	Dec 09, 2014	Substantially Equivalent	Roche Diagnostics Operations (Rdo)
K013643	AUSAM TOTAL ALBUMIN ASSAY	Aug 14, 2003	Substantially Equivalent	Ausam Biotecthnologies, Inc.
K991800	HEMOCHEK URINE COLLECTION KIT	Sep 24, 1999	Substantially Equivalent	Osborn Group, Inc.
K971458	ENZIP IMMUNOTURBIDIMETRIC MICROALBUMIN ASSAY KIT	Sep 02, 1997	Substantially Equivalent	Diagnostic Specialties
K965035	IMMAGE IMMUNOCHEMISTRY SYSTEM MICROALBUMIN (MA) REAGENT	Apr 17, 1997	Substantially Equivalent	Beckman Instruments, Inc.
K944664	WAKO MICRO-ALBUMIN B/WAKO MICRO ALBUMIN CALIBRATOR	Feb 07, 1995	Substantially Equivalent	Wako Chemicals USA, Inc.
K936202	URINARY ALBUMIN TEST PACK	May 09, 1994	Substantially Equivalent	Dupont Medical Products
K935662	SYNERMED IR 500 CHEMISTRY ANALYZER	Apr 26, 1994	Substantially Equivalent	Synermed, Inc.
K903123	RAICHEM(TM) SPIA(TM) MICROALBULMIN REAGENT	Sep 14, 1990	Substantially Equivalent	Reagents Applications, Inc.
K902216	WAKO(TM) MICRO-ALBUMIN	Jun 18, 1990	Substantially Equivalent	Wako Chemicals USA, Inc.
K895883	BECKMAN MA MICROALBUMIN REAGENT KIT	Dec 27, 1989	Substantially Equivalent	Beckman Instruments, Inc.
K870516	ALBUMIN SCREEN TEST	Oct 20, 1987	Substantially Equivalent	Sclavo, Inc.
K842915	SULFOSALICYLIC ACID, 3% W/V	Aug 10, 1984	Substantially Equivalent	E K Ind., Inc.