Product Code: JXA FDA class 1 21 CFR 866.2660

Kit, Screening, Urine

Microbiology

Kit, Screening, Urine is a diagnostic microbiology kit designed to rapidly screen urine specimens for the presence of significant bacteriuria or urinary pathogens, helping to determine whether further culture and susceptibility testing is warranted. It is classified as FDA Class 1, the lowest risk category, subject to general controls only. The product code is JXA, regulated under 21 CFR 866.2660, and falls within the Microbiology medical specialty.

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FEI Numbers

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Basic Information

Product Code: JXA
Device Class: FDA class 1
Regulation Number: 866.2660
Medical Specialty: Microbiology
Review Panel: MI
Submission Type: 4

Device Characteristics

✗

GMP Exempt

✗

Implant

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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 44 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K011043	OSMETECH MICROBIAL ANALYSER-URINARY TRACT INFECTION DETECTOR (OMA-UTI)	Nov 30, 2001	Substantially Equivalent	Osmetech
K981084	URISCREEN	Oct 07, 1998	Substantially Equivalent	Diatech Diagnostics,Inc.
K972676	URINE SCREENING DEVICE	Feb 23, 1998	Substantially Equivalent	Combact Diagnostic Systems , Ltd.
K952246	TRI-TECHIN. CUSTOM BLOOD AND/OR URINE TRANSPORT KIT	Jun 20, 1995	Substantially Equivalent	Tri-Tech, Inc.
K950257	MULTIPLE (IZON DBS & URINE COLLECTION KIT)	Apr 14, 1995	Substantially Equivalent	Izon Business Products, Inc.
K950246	MULTIPLE (IZON URINE COLLECTION KIT)	Mar 21, 1995	Unknown	Izon Business Products, Inc.
K950221	MULTIPLE (IZON BLOOD & URINE COLLECTION KIT)	Mar 21, 1995	Unknown	Izon Business Products, Inc.
K934759	CULTURIA MACCONKEY-MUG	Sep 09, 1994	Substantially Equivalent	Clinical Convenience Products, Inc.
K924218	BAC-T-SCREEN	Feb 03, 1993	Substantially Equivalent	Biomerieux Vitek, Inc.
K921045	DIASLIDE URINE CULTURING DEVICE	Sep 28, 1992	Substantially Equivalent	Savyon Diagnostics , Ltd.
K911846	URI-THREE(TM), MODIFICATION	Oct 04, 1991	Substantially Equivalent	Culture Kits, Inc.
K903470	QUALTURE	Dec 13, 1990	Substantially Equivalent	Future Medical Technologies Intl., Inc.
K894805	RAPIDEC UR	Sep 26, 1989	Substantially Equivalent	Dms Products, Inc.
K892216	GEN-PROBE PACE SYSTEM URINE SCREEN	Sep 15, 1989	Substantially Equivalent	Gen-Probe, Inc.
K882211	URISCREEN	Sep 30, 1988	Substantially Equivalent	Diatech Diagnostica , Ltd.
K883385	RESUBMITTED UTISCREEN(TM) BACTERIAL ATP TEST	Sep 07, 1988	Substantially Equivalent	Los Alamos Diagnostics
K881439	MODIFIED UTISCREEN(TM) BACTERIAL ATP TEST SYSTEM	Apr 28, 1988	Substantially Equivalent	Los Alamos Diagnostics
K873086	ROUND 1	Aug 24, 1987	Substantially Equivalent	Bioclinical Systems, Inc.
K870731	LYFO KWIK(TM) RUS KIT	Jun 17, 1987	Substantially Equivalent	Micro-Bio-Logics
K864177	N-D URINE TUBE SYSTEM (N-D TUBE/CAP/PIPETTE)	Feb 24, 1987	Substantially Equivalent	Cls Co.
K864202	UTISCREEN(R) BACTERIAL ATP TEST	Feb 13, 1987	Substantially Equivalent	Los Alamos Diagnostics
K862195	RAPID BACTERIURIA SCREEN (RBS)	Jun 30, 1986	Substantially Equivalent	New Horizons Diagnostics Co.
K861631	SLIDE CULTURE U 'EIKEN'	Jun 10, 1986	Substantially Equivalent	Syn-Kit, Inc.
K860905	URICHECK	Apr 04, 1986	Substantially Equivalent	Difco Laboratories, Inc.
K860483	FILTRA-CHECK-UTI	Apr 04, 1986	Substantially Equivalent	Applied Polytechnology, Inc.
K851399	BAC-T-SCREEN	Jun 04, 1985	Substantially Equivalent	Marion Laboratories, Inc.
K843834	BACTERIURIA DETECT. DEVICE APTEK II	Nov 29, 1984	Substantially Equivalent	Applied Polytechnology, Inc.
K843833	BACTERIURIA DETECT DEVICE, MULTI SAMPLER	Nov 29, 1984	Substantially Equivalent	Applied Polytechnology, Inc.
K833834	ORTHO BACTERIURIA DETECTION SYS	Mar 12, 1984	Substantially Equivalent	Ortho Diagnostic Systems, Inc.
K832975	BACTERUERIA SCREENING PROCEDURE	Nov 14, 1983	Substantially Equivalent	Turner Designs, Inc.
K830252	DIPCHEX DIP-SLIDE CULTURE SYS	Mar 07, 1983	Substantially Equivalent	Granite Diagnostics, Inc.
K823850	BAC-T-SCREEN BACTERIURIA DETECTION DEV	Mar 01, 1983	Substantially Equivalent	Marion Laboratories, Inc.
K820126	RAPID BACTERIURIA SCREENING TEST	Jan 07, 1983	Substantially Equivalent	Analytical Luminescence Laboratory, Inc.
K810746	LUMAC'S BACTERIURIA SCREENING KIT	Jul 31, 1981	Substantially Equivalent	Lumac
K800626	URI-DIP (R)	Apr 24, 1980	Substantially Equivalent	Pharma-Medica of Scandinavia, Ltd.
K800215	CULTURIA MACCONKEY/CLED #DM87	Feb 13, 1980	Substantially Equivalent	Clinical Convenience Products, Inc.
K792579	CULTURIA MACCONKEY/COLUMBIA CNA	Jan 11, 1980	Substantially Equivalent	Clinical Convenience Products, Inc.
K792284	CULTURIA EMB/COLUMBIA CNA W/5% SHEEP	Dec 19, 1979	Substantially Equivalent	Clinical Convenience Products, Inc.
K781370	MS-2 AUTOMATED URINE SCREENING SYSTEM	Sep 20, 1978	Substantially Equivalent	Abbott Laboratories
K781536	VAC-U-PAC KIDNEY CASSETTE	Sep 14, 1978	Substantially Equivalent	E-Z-Em, Inc.
K780803	TILL-U-TEST, DIP SLIDE	Jun 06, 1978	Substantially Equivalent	Biotron , Ltd.
K780021	URINE SCREENING KITS	Mar 17, 1978	Substantially Equivalent	Diagnostic Culture System
K780109	TILL-U=TEST	Jan 31, 1978	Substantially Equivalent	Clinifax Industries, Ltd.
K771672	MICROCULT-ID	Dec 09, 1977	Substantially Equivalent	Miles Laboratories, Inc.