Product Code: JIR FDA class 1 21 CFR 862.1645

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

Clinical Chemistry

This device is a clinical chemistry reagent that uses an indicator (colorimetric dye) method to detect protein or albumin in urine on a qualitative, non-quantitative basis, supporting urinalysis screening in clinical laboratories. It is classified as FDA Class 1, the lowest risk tier, subject to general controls only and exempt from premarket notification requirements. The product code is JIR, regulated under 21 CFR 862.1645, and assigned to the Clinical Chemistry medical specialty.

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FEI Numbers

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Basic Information

Product Code: JIR
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 38 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K222921	Minuteful-kidney test	Sep 08, 2023	Substantially Equivalent	Healthy.Io, Ltd.
K210069	Minuteful - kidney test	Jul 06, 2022	Substantially Equivalent	Healthy.Io, Ltd.
K150330	Mission Urinalysis Reagent Strips (Microalbumin/Creatinine)	Apr 30, 2015	Substantially Equivalent	ACON Laboratories, Inc.
K061419	TECO MICROALBUMIN 2-1 COMBO STRIPS	Jan 26, 2007	Substantially Equivalent	Teco Diagnostics
K022538	IMMUNODIP URINARY ALBUMIN SCREEN ASSAY, CATALOGUE NUMBER 790-25	Aug 23, 2002	Substantially Equivalent	Diagnostic Chemicals, Ltd. (Usa)
K001810	URISITE URINE COLLECTION KIT FOR MICROALBUMIN/CREATININE TESTING	Aug 14, 2000	Substantially Equivalent	Flexsite Diagnostics, Inc.
K994035	IMMUNODIP URINARY ALBUMIN SCREEN, MODEL 790-01, 790-15	Feb 01, 2000	Substantially Equivalent	Diagnostic Chemicals , Ltd.
K992257	NEW MULTIPLES REAGENT STRIPS	Nov 24, 1999	Substantially Equivalent	Bayer Corp.
K991315	MICROALBUSTIX REAGENT STRIPS (OTC)	Nov 12, 1999	Substantially Equivalent	Bayer Corp.
K983774	UALB	Jan 28, 1999	Substantially Equivalent	Abbott Laboratories
K972960	HEALTH CHECK URI-TEST PROTEIN IN URINE	Oct 07, 1998	Substantially Equivalent	Tcpi, Inc.
K982219	MICROALBUSTIX REAGENT STRIPS	Aug 12, 1998	Substantially Equivalent	Bayer Corp.
K972337	DCLARE IMMUNODIP STICKFOR MICROALBUMINURIA	Aug 08, 1997	Substantially Equivalent	Diagnostic Chemicals , Ltd.
K970932	ORGENTEC MICRO-ALBUMIN EIA ASSAY	Apr 08, 1997	Substantially Equivalent	American Laboratory Products Co., Ltd.
K963142	DCA 2000 + MICROALBUMIN/CREATININE ASSAY	Sep 27, 1996	Substantially Equivalent	Bayer Corp.
K951222	TOTAL PROTEIN (URINE)	Apr 24, 1996	Substantially Equivalent	Randox Laboratories, Ltd.
K960274	ORGENTEC MICRO-ALBUMIN PIN EIA ASSAY	Mar 29, 1996	Substantially Equivalent	Orgentec
K955438	URINE REAGENT STRIPS-3 PARAMETERS (MODIFICATION)	Jan 29, 1996	Substantially Equivalent	Teco Diagnostics
K954346	CHEMSTRIP MICRAL URINE TEST STRIPS	Oct 26, 1995	Substantially Equivalent	Boehringer Mannheim Corp.
K932950	TINA-QUANT MICROALBUMIN	Feb 10, 1995	Substantially Equivalent	Boehringer Mannheim Corp.
K934146	N-ASSAY TIA MICROALBUMIN	Jan 11, 1994	Substantially Equivalent	Crestat Diagnostics, Inc.
K922032	ENZIP URINARY MICROALBUMIN TEST	Jul 30, 1992	Substantially Equivalent	Diagnostic Specialties
K920216	SYN ELISA MICRO ALBUMIN	Mar 11, 1992	Substantially Equivalent	Elias U.S.A., Inc.
K912543	MICRO ALBUMIN EIA TEST KIT	Jul 19, 1991	Substantially Equivalent	Immuno Diagnostic Center, Inc.
K912246	TARGET MICROALBUMINURIA TEST	Jul 19, 1991	Substantially Equivalent	Texas Immunology, Inc.
K904752	CHEMSTRIP(R) MICRAL(TM) URINE TEST STRIPS	Apr 12, 1991	Substantially Equivalent	Boehringer Mannheim Corp.
K902204	STANBIO CSF/URINE TOTAL PROTEIN TEST SET	Aug 22, 1990	Substantially Equivalent	Stanbio Laboratory
K896440	KENLOR PYROGALLOL RED MICROPROTEIN ASSAY KIT	Feb 16, 1990	Substantially Equivalent	Kenlor Industries, Inc.
K894169	BIOTEL MICROALBUMINURIA (TM)	Sep 18, 1989	Substantially Equivalent	American Diagnostic Corp.
K891544	DIALBUMIN	Jun 09, 1989	Substantially Equivalent	Exocell, Inc.
K890846	BIOTROL URINE PROTEINS REAGENT	Mar 21, 1989	Substantially Equivalent	Biotrol, USA, Inc.
K882538	PROGENE MICROALBUMINURIA SCREEN	Mar 13, 1989	Substantially Equivalent	Progene Corp.
K885053	BIOTROL URINE PROTEINS REAGENT	Jan 30, 1989	Substantially Equivalent	Biotrol, USA, Inc.
K884146	ALBUWELL	Jan 23, 1989	Substantially Equivalent	Exocell, Inc.
K874909	MICRO-BUMINTEST REAGENT TABLETS	Apr 28, 1988	Substantially Equivalent	Miles Laboratories, Inc.
K851338	DOUBLE ANTIBODY ALBUMIN FOR DETECT MICROALBUMINURI	Apr 07, 1986	Substantially Equivalent	Diagnostic Products Corp.
K830977	HELENA BIOSTRIP P	Apr 28, 1983	Substantially Equivalent	Helena Laboratories
K811219	KOVA STRIP 6	May 21, 1981	Substantially Equivalent	Icl Scientific