Product Code: LJC FDA class 1 21 CFR 866.3120

Enzyme Linked Immunoabsorbent Assay, (Chlamydiae Group)

Microbiology

An enzyme-linked immunosorbent assay (ELISA) for the Chlamydiae group is a laboratory diagnostic test used to detect antibodies to Chlamydia species in patient specimens, supporting the serological diagnosis of chlamydial infections in the microbiology laboratory. The device is FDA Class 1, the lowest risk category, subject to general controls. It carries product code LJC and is regulated under 21 CFR 866.3120 within the Microbiology specialty. This device is eligible for third-party review.

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FEI Numbers

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Basic Information

Product Code: LJC
Device Class: FDA class 1
Regulation Number: 866.3120
Medical Specialty: Microbiology
Review Panel: MI
Submission Type: 1

Device Characteristics

✗

GMP Exempt

✗

Implant

✗

Life Sustain/Support

✓

Third Party

—

Summary Malfunction Reporting

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 67 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K032330	CT OIA	Mar 02, 2004	Substantially Equivalent	Thermo Biostar, Inc.
K033865	IDEIA PCE CHLAMYDIA	Jan 21, 2004	Substantially Equivalent	Dakocytomation, Ltd.
K033079	CHLAMYDIA IGG ELISA TEST SYSTEM	Nov 26, 2003	Substantially Equivalent	Trinity Biotech USA
K982210	MODIFICATION OF SYVA MICROTRAK II CHLAMYDIA EIA	Jul 09, 1998	Substantially Equivalent	Dade Behring, Inc.
K962558	CHLAMYDIA IGG ELISA TEST SYSTEM	Feb 24, 1997	Substantially Equivalent	Armkel, LLC
K960850	ACCESS CHLAMYDIA ASSAY	Feb 04, 1997	Substantially Equivalent	Bio-Rad Laboratories, Inc.
K955627	VIDAS CHLAMYDIA BLOCKING ASSAY	Oct 07, 1996	Substantially Equivalent	Biomerieux Vitek, Inc.
K936054	IMX SELECT CHLAMYDIA	May 30, 1996	Substantially Equivalent	Abbott Laboratories
K940564	IDEIA(TM) CHLAMYDIA BLOCKING REAGENTS, MODIFICATION	Jan 11, 1996	Substantially Equivalent	Dako Diagnostics , Ltd.
K951010	CHLAMYDIA OIA	Oct 07, 1995	Substantially Equivalent	Biostar, Inc.
K946276	QUICKVUE(R) CHLAMYDIA TEST	May 19, 1995	Substantially Equivalent	Quidel Corp.
K935807	ACCESS(R) CHLAMYDIA EIA AND BLOCKING ASSAY	May 19, 1995	Substantially Equivalent	Bio-Rad Laboratories, Inc.
K935393	CHLAMYDIA MICROPLATE EIA, CHLAMYDIA MICROPLAE EIA BLOCKING ASSAY	Sep 20, 1994	Substantially Equivalent	Bio-Rad Laboratories, Inc.
K926090	SYVA MICROTRAK(R) II CHLAMYDIA EIA BLOCK REAGENT	Sep 30, 1993	Substantially Equivalent	Syva Co.
K921747	MICRO TRAK XL SYSTEM	Oct 01, 1992	Substantially Equivalent	Syva Co.
K921462	MICROTRAK(R) II CHLAMYDIA EIA ASSAY	Sep 25, 1992	Substantially Equivalent	Syva Co.
K920503	SYVA MICROTRAK CHLAMYDIA EIA	Sep 25, 1992	Substantially Equivalent	Syva Co.
K921321	ORTHO CHLAMYDIA ANTIGEN ELISA TEST	Aug 11, 1992	Substantially Equivalent	Ortho Diagnostic Systems, Inc.
K914327	SEROELISA(TM) CHLAMYDIA IGA TEST KIT	Jun 09, 1992	Substantially Equivalent	Savyon Diagnostics , Ltd.
K915281	SEROLISA CHLAMYDIA IGG TEST KIT	Mar 23, 1992	Substantially Equivalent	Savyon Diagnostics , Ltd.
K915884	VIDAS CHLAMYDIA ASSAY, MODIFICATION	Mar 04, 1992	Substantially Equivalent	Vitek Systems, Inc.
K912680	ANTIGENZ CHLAMYDIA	Jul 22, 1991	Substantially Equivalent	Baxter Diagnostics, Inc.
K905787	VIDAS CHLAMYDIA ASSAY VITEK IMMUNDIAG ASSAY SYST	Apr 29, 1991	Substantially Equivalent	Vitek Systems, Inc.
K904189	CIBA CORNING MAGIC LITE CHLAMYDIA IMMUNOASSAY	Mar 27, 1991	Substantially Equivalent	Ciba Corning Diagnostics Corp.
K910668	ORTHO* CHLAMYDIA ANTIGEN ELISA TEST/MODIFICATION	Mar 19, 1991	Substantially Equivalent	Ortho Diagnostic Systems, Inc.
K905179	SYVA MICROTRAK CHLAMLYDIA EIA, MODIFICATION	Mar 12, 1991	Substantially Equivalent	Syva Co.
K904725	CHLAMYDIA SYSTEM SOFTWARE (CSS)	Jan 14, 1991	Substantially Equivalent	Kallestad Diag, A Div. of Erbamont, Inc.
K903132	ORTHO CHLAMYDIA ANTIGEN ELISA/ELISA CULT EXTRA BUF	Dec 21, 1990	Substantially Equivalent	Ortho Diagnostic Systems, Inc.
K903765	QUIDEL CHLAMYDIA POSITIVE CONTROL	Oct 02, 1990	Substantially Equivalent	Quidel Corp.
K903758	SYVA MICROTRAK EIA ACCESSORY REAGENTS	Sep 12, 1990	Substantially Equivalent	Syva Co.
K901972	ADD'L CLAIMED INTENDED USE FOR IDEIA(TM) CHLAMYDIA	Sep 05, 1990	Substantially Equivalent	Novo Nordisk Diagnostics, Ltd.
K902270	CIBA CORNING MAGIC LITE CHLAMYDIA IMMUNOASSAY	Jul 31, 1990	Substantially Equivalent	Ciba Corning Diagnostics Corp.
K901660	QUIDEL CHLAMYDIA TEST	Jul 27, 1990	Substantially Equivalent	Quidel Corp.
K902253	PATHFINDER(TM) CHLAMYDIA MICROPLATE KIT	Jul 26, 1990	Substantially Equivalent	Kallestad Diag, A Div. of Erbamont, Inc.
K901934	KODAK SURECELL(TM) CHLAMYDIA CONTROL FLUID SET	Jun 20, 1990	Substantially Equivalent	Eastman Kodak Company
K900973	VISUWELL(R) CHLAMYDIA	May 15, 1990	Substantially Equivalent	Adi Diagnostics, Inc.
K900543	CHLAMYDIAZYME DIAGNOSTIC KIT	May 03, 1990	Substantially Equivalent	Abbott Laboratories
K895468	ORGENICS IMMUNOCOMB(TM) CHLAMYDIA TRACHOMATIS IGG	Mar 13, 1990	Substantially Equivalent	Orgenics, Ltd.
K900402	ADD'L USES FOR THE KODAK SURECELL CHLAMYDIA KIT	Mar 08, 1990	Substantially Equivalent	Eastman Kodak Company
K896032	MODIFIED ELISA FOR CHLAMYDIA	Jan 29, 1990	Substantially Equivalent	Fairleigh Dickinson Laboratories, Inc.
K895280	CLEARVIEW CHLAMYDIA	Jan 29, 1990	Substantially Equivalent	Unipath , Ltd.
K895505	KODAK SURECELL CHLAMYDIA TEST KIT (ADD'L USES)	Jan 02, 1990	Substantially Equivalent	Eastman Kodak Company
K895122	CIBA CORNING MAGIC LITE CHLAMYDIA IMMUNOASSAY	Oct 30, 1989	Substantially Equivalent	Ciba Corning Diagnostics Corp.
K893676	ABBOTT TESTPACK CHLAMYDIA	Jul 25, 1989	Substantially Equivalent	Abbott Laboratories
K892371	CHLAMYDIAZYME BLOCKING REAGENT	Jun 02, 1989	Substantially Equivalent	Abbott Laboratories
K890196	MICROTRAK CHLAMYDIA EIA	Mar 22, 1989	Substantially Equivalent	Syva Co.
K885006	CHLAMYDIAZYME/COMMANDER INSTRUMENTATION	Dec 16, 1988	Substantially Equivalent	Abbott Laboratories
K880799	MODIFIED IDEIA CHLAMYDIA TEST	Dec 08, 1988	Substantially Equivalent	Boots-Celltech Diagnostics, Inc.
K884517	PATHFINDER(TM) CHLAMYDIA EIA DETECT KIT/MODIFIED	Nov 30, 1988	Substantially Equivalent	Kallestad Diag, A Div. of Erbamont, Inc.
K882923	KODAK SURECELL CHLAMYDIA TEST KIT	Nov 10, 1988	Substantially Equivalent	Eastman Kodak Company
K883266	FDL ELISA FOR CHLAMYDIA	Oct 25, 1988	Substantially Equivalent	Fairleigh Dickinson Laboratories, Inc.
K882676	PHARMACIA CHLAMYDIA EIA	Aug 29, 1988	Substantially Equivalent	Pharmacia, Inc.
K880783	ABBOTT TESTPACK CHLAMYDIA	Jul 25, 1988	Substantially Equivalent	Abbott Laboratories
K882535	ABBOTT TESTPACK(TM) CHLAMYDIA POSITIVE CONTROL	Jul 14, 1988	Substantially Equivalent	Abbott Laboratories
K880469	CHLAMYDIAZYME(TM)	May 23, 1988	Substantially Equivalent	Abbott Laboratories
K880824	PATHFINDER(TM) CHLAMYDIA EIA DETECTION KIT	Apr 12, 1988	Substantially Equivalent	Kallestad Diag, A Div. of Erbamont, Inc.
K864457	CHLAMYSET ANTIBODY EIA	Sep 11, 1987	Substantially Equivalent	Orion Corp.
K872148	VIVID CHLAMYDIA(TM)	Aug 19, 1987	Substantially Equivalent	Seragen Diagnostics, Inc.
K872056	MODIFIED (DIRECTIONS FOR USE) FOR IDEIA(TM) TEST	Jun 15, 1987	Substantially Equivalent	Boots-Celltech Diagnostics, Inc.
K864842	CHLAMYDIAZYME DIAGNOSTIC KIT	Apr 29, 1987	Substantially Equivalent	Abbott Laboratories
K863490	ORTHO* CHLAMYDIA ANTIGEN ELISA TEST & TRANSPORT	Nov 05, 1986	Substantially Equivalent	Ortho Diagnostic Systems, Inc.
K862948	CHLAMYDIA TISSUE CULTURE CONFIRMATION TEST (EIA)	Oct 17, 1986	Substantially Equivalent	Intercare Diagnostics, Inc.
K862638	VISIBLE-CHLAMYDIA(TM) TEST SYSTEM	Aug 26, 1986	Substantially Equivalent	Isolab, Inc.
K861966	MODIFIED IDEIA CHLAMYDIA TEST	Aug 19, 1986	Substantially Equivalent	Boots-Celltech Diagnostics, Inc.
K843120	APPLELISA CHLAMYDIA TRACHOMATIS ANTI	Sep 12, 1984	Substantially Equivalent	Apple Diagnostic Products
K831962	CHLAMYDIAZYME, ENZYME IMMUNOASSAY DETEC	Oct 05, 1983	Substantially Equivalent	Abbott Laboratories
K821967	CHLAMYDELISA TEST KIT	Aug 03, 1982	Substantially Equivalent	M.A. Bioproducts