Product Code: JJW FDA class 1 21 CFR 862.1660

Urinalysis Controls (Assayed And Unassayed)

Clinical Chemistry

This device consists of assayed and unassayed urinalysis controls used in clinical laboratories to monitor the performance and reliability of urinalysis test systems that measure parameters such as glucose, protein, ketones, blood, pH, and specific gravity in urine specimens. It is classified as FDA Class 1, the lowest risk tier, requiring only general controls without a premarket submission. The product code is JJW, regulated under 21 CFR 862.1660, and assigned to the Clinical Chemistry medical specialty.

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Basic Information

Product Code: JJW
Device Class: FDA class 1
Regulation Number: 862.1660
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 61 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K170091	UA-Cellular Complete	Feb 09, 2017	Substantially Equivalent	Streck
K142262	AUTION CHECK PLUS	Apr 10, 2015	Substantially Equivalent	Quantimetrix Corp.
K131444	UA-CELLULAR COMPLETE	Jan 29, 2014	Substantially Equivalent	Streck
K110846	RANDOX URINALYSIS CONTROLS, LEVELS 1 AND 2	Sep 30, 2011	Substantially Equivalent	Randox Laboratories Limited
K103387	MISSION LIQUID URINE CONTROL, MISSION LIQUID DIPTUBE URINE CONTROL, MISSION DRY STRIP URINE CONTROL	Feb 02, 2011	Substantially Equivalent	ACON Laboratories, Inc.
K081908	CLINIQA LIQUID QC URINALYSIS CONTROLS, LEVELS 1 AND 2	Jan 16, 2009	Substantially Equivalent	Cliniqa Corporation
K072640	IRISPEC,CA/CB/CC	Dec 21, 2007	Substantially Equivalent	Iris Diagnostics
K070848	LIQUICHEK URINALYSIS CONTROL (BI-LEVEL), CONTROL LEVEL1, LEVEL 2,MINIPAK, 435,436,437,435X	Apr 25, 2007	Substantially Equivalent	Bio-Rad, Diagnostics Grp.
K052242	ADVIA CHEMISTRY MICROALBUMIN CONTROLS	Oct 03, 2005	Substantially Equivalent	Bayer Healthcare, LLC
K043266	RANDOX URINE CONTROLS	Feb 15, 2005	Substantially Equivalent	Randox Laboratories, Ltd.
K042446	QUANTIFY CONTROL AND QUANTIFY PLUS CONTROLS	Nov 02, 2004	Substantially Equivalent	Bio-Rad Laboratories, Inc.
K031441	URICHEMTRAK LIQUID ASSAYED URINE CONTROL	Jul 01, 2003	Substantially Equivalent	Medical Analysis Systems, Inc.
K031231	LIQUICHECK URINALYSIS CONTROL BILEVEL, MODEL 435, LIQUICHEK URINALYSIS CONTROL LEVEL 2, MODEL 436, LIQUICHEK URINALYSIS	Jun 18, 2003	Substantially Equivalent	Bio-Rad
K023928	MAS UA CONTROL LIQUID ASSAYED URINALYSIS CONTROL, DADE ASSAYED URINALYSIS CONTROL	Dec 11, 2002	Substantially Equivalent	Medical Analysis Systems, Inc.
K022085	J&S MEDICAL SENTRY URINE DIPSTICK CONTROL	Jul 25, 2002	Substantially Equivalent	J & S Medical Assoc., Inc.
K021155	MAS UA CONTROL, DADE UA CONTROL- LIQUID ASSAYED URINALYSIS CONTROL	Apr 29, 2002	Substantially Equivalent	Medical Analysis Systems, Inc.
K000874	URINE CONTROL 1, CAT. NO. 903600, URINE CONTROL 2, CAT. NO. 904100	Apr 18, 2000	Substantially Equivalent	Bio-Rad
K992578	URINE CHEMISTRY CONTROL, LEVEL 2	Sep 03, 1999	Substantially Equivalent	Consolidated Technologies, Inc.
K992576	URINE CHEMISTRY CONTROL, LEVEL 1	Sep 03, 1999	Substantially Equivalent	Consolidated Technologies, Inc.
K991917	OSTEOMARK NTX POINT OF CARE (POC) CONTROL SET	Jul 12, 1999	Substantially Equivalent	Metrika, Inc.
K981933	URICHEMTRAK LIQUID ASSAYED CONTROL LEVELS 1 AND 2	Jun 29, 1998	Substantially Equivalent	Medical Analysis Systems, Inc.
K973451	MAS LIQUID URINALYSIS CONTROL LEVEL 1, LEVEL 2 AND LEVEL 3	Sep 29, 1997	Substantially Equivalent	Medical Analysis Systems, Inc.
K972710	QUANTIFY(901)	Aug 15, 1997	Substantially Equivalent	Hematronix, Inc.
K952840	KENLOR LIQUID TOTAL URINE CONTROL	Jul 19, 1995	Substantially Equivalent	Kenlor Industries, Inc.
K945913	IRISPEC URINE CHEMISTRY CONTROL PART A AND B	Apr 05, 1995	Substantially Equivalent	International Remote Imaging Systems
K943780	NEGATIVE CONTROL STRIPS FOR URINALYSIS (CHEX-STIX, CLINITEK AUTO 2000, CLINITEX ATLAS)	Oct 31, 1994	Substantially Equivalent	Heraeus Kulzer, Inc.
K942853	KOVA LIQUA-TROL	Oct 04, 1994	Substantially Equivalent	Hycor Biomedical, Inc.
K935062	MAS LIQUID URINALYSIS CONTROL	Jan 27, 1994	Substantially Equivalent	Medical Analysis Systems, Inc.
K934257	U-TROL LIQUID URINE DIPSTICK CONTROL	Nov 26, 1993	Substantially Equivalent	P.T. Meditrol
K931467	CHEK-STIX CONTROL STRIPS FOR URINALYSIS	May 11, 1993	Substantially Equivalent	Heraeus Kulzer, Inc.
K902699	SHAPE-ACTIO URINALYSIS CONTROLS(ASSAYED & UNASSAY)	Jul 16, 1990	Substantially Equivalent	Actio, Inc.
K891286	BIOTROL CHEMISTRY URINE CONTROL	Apr 10, 1989	Substantially Equivalent	Biotrol, USA, Inc.
K890577	KENLOR LIQUID URINE CONTROL	Mar 09, 1989	Substantially Equivalent	Kenlor Industries, Inc.
K890534	MODIFIED URIQUAL(TM) URINALYSIS CONTROL LEVEL 1	Mar 08, 1989	Substantially Equivalent	Fisher Scientific Co., LLC
K884424	LYPHOCHEK ROUTINE URINE CONTROLS 1 & 2 (HUMAN)	Dec 15, 1988	Substantially Equivalent	Bio-Rad
K880496	LYPHOCHEK QUANTITATIVE URINE CONTROL NORMAL (1)	Mar 16, 1988	Substantially Equivalent	Bio-Rad
K880495	LYPHOCHEK QUANTITATIVE URINE CONTROL ABNORMAL (2)	Mar 15, 1988	Substantially Equivalent	Bio-Rad
K874890	QUANTIMETRIX URINE DIPSTICK CONTROL	Jan 21, 1988	Substantially Equivalent	Quantimetrix Medical Industries
K863127	TESTPACK ACUTE HCG URINGE CONTROLS	Sep 15, 1986	Substantially Equivalent	Abbott Laboratories
K861756	V-TREND QC URINE CHEMISTRY CONTROLS LEVEL, I & II	Jul 07, 1986	Substantially Equivalent	Texas Immunology, Inc.
K853603	CANTROL URINE DIPSTICK CONTROL TWO LEVELS	Oct 08, 1985	Substantially Equivalent	Canyon Diagnostics, Inc.
K852295	UROL-GUANT	Jul 22, 1985	Substantially Equivalent	Dimension Diagnostics
K843565	KOVA TROL I,II, III HUMAN URINE-DRIED	Oct 05, 1984	Substantially Equivalent	Icl Scientific
K842366	OXALATE URINE CONTROLS NORMAL & ELEVAT	Sep 12, 1984	Substantially Equivalent	Sigma Chemical Co.
K840848	BIOSURE	May 01, 1984	Substantially Equivalent	Helena Laboratories
K840618	LIQUI-URA CHEMISTRY URINE CONTROLS	Apr 04, 1984	Substantially Equivalent	Biodiagnostic Intl
K832713	IRI SPEC URINALYSIS CONTROL	Dec 22, 1983	Substantially Equivalent	Intl. Remote Imaging Systems
K831526	URINE TOTAL PROTEIN CONTROL	Aug 12, 1983	Substantially Equivalent	Quantimetrix Corp.
K831994	BIOCHECK POSITIVE URINE CONTROL	Aug 08, 1983	Substantially Equivalent	Helena Laboratories
K830834	NEGATIVE URINE CONTROL	Apr 12, 1983	Substantially Equivalent	Helena Laboratories
K822540	COUNT-10 TROL	Oct 08, 1982	Substantially Equivalent	Texas Immunology, Inc.
K810917	KOVA TROL I HUMAN URINE (DRIED)	Apr 14, 1981	Substantially Equivalent	Icl Scientific
K792376	QUANTITATIVE CONTROL URINE II (HUMAN)	Dec 06, 1979	Substantially Equivalent	Environmental Chemical Specialties
K792374	QUANTITATIVE CONTROL URINE I (HUMAN)	Dec 06, 1979	Substantially Equivalent	Environmental Chemical Specialties
K781961	CONTROL STRIP FOR VISUAL URINALYSIS	Feb 08, 1979	Substantially Equivalent	Miles Laboratories, Inc.
K781691	CHEMSTRIP CONTROL	Dec 20, 1978	Substantially Equivalent	Boehringer Mannheim Corp.
K780802	ARMTROL AND FERMTROL	Jun 13, 1978	Substantially Equivalent	Biotron , Ltd.
K780482	KOVA TROL III	May 03, 1978	Substantially Equivalent	Icl Scientific
K771713	TEK-CHEK-2	Oct 18, 1977	Substantially Equivalent	Miles Laboratories, Inc.
K770390	URINALYSIS PROFICIENCY	May 03, 1977	Substantially Equivalent	Miles Laboratories, Inc.
K760863	PRODUCT #K3002 KETOTROL-N(URINE CONTROL)	Nov 02, 1976	Substantially Equivalent	Sigma Chemical Co.