Product Code: LEH FDA class 2 21 CFR 862.3950

Radioimmunoassay, Vancomycin

Clinical Toxicology

Radioimmunoassay for vancomycin is a laboratory test system using radiolabeled antibodies to measure serum vancomycin concentrations in patients receiving this glycopeptide antibiotic, which requires therapeutic drug monitoring to achieve bactericidal efficacy while avoiding nephrotoxicity and ototoxicity. It is classified as FDA Class 2, requiring 510(k) premarket clearance. The product code is LEH, regulated under 21 CFR 862.3950, in the Clinical Toxicology specialty. Third-party review eligibility applies.

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510(k)s

FEI Numbers

Registration Numbers

Unique Applicants

Years Active

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Basic Information

Product Code: LEH
Device Class: FDA class 2
Regulation Number: 862.3950
Medical Specialty: Clinical Toxicology
Review Panel: TX
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 31 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K222439	Atellica® CH Phencyclidine (Pcp), Atellica® CH Vancomycin (Vanc)	Aug 08, 2023	Substantially Equivalent	Siemens Healthcare Diagnostics, Inc.
K160202	Trinidad CH Vancomycin (Vanc), Trinidad CH Drug 3 Calibrator (DRUG3 CAL)	Apr 27, 2016	Substantially Equivalent	Siemens Healthcare Diagnostics, Inc.
K152245	ONLINE TDM Vancomycin Gen.3	Jan 08, 2016	Substantially Equivalent	Roche Diagnostics Operations (Rdo)
K123947	ARCHITECT IVANCOMYCIN	Aug 29, 2013	Substantially Equivalent	Biokit, S.A.
K072036	ARCHITECT IVANCOMYCIN REAGENTS AND ARCHITECT IVANCOMYCIN CALIBRATORS, MODELS: 1P30-25 AND 1P30-01	Mar 19, 2008	Substantially Equivalent	Biokit, S.A.
K063045	IMMULITE 2000, IMMULITE 2500 VANCOMYCIN	Dec 05, 2006	Substantially Equivalent	Diagnostic Products Corp.
K060586	ENZYME IMMUNOASSAY, VANCOMYCIN	May 11, 2006	Substantially Equivalent	Roche Diagnostics Corp.
K050419	QMS VANCOMYCIN	Apr 01, 2005	Substantially Equivalent	Seradyn, Inc.
K043386	VITROS CHEMISTRY PRODUCTS VANC REAGENT, CALIBRATOR KIT 11 AND TDM PERFORMANCE VERIFIERS I, II AND III	Feb 07, 2005	Substantially Equivalent	Ortho-Clinical Diagnostics, Inc.
K032811	CEDIA VANCOMYCIN ASSAY	Nov 24, 2003	Substantially Equivalent	Microgenics Corp.
K020692	EMIT 2000 VANCOMYCIN ASSAY	May 10, 2002	Substantially Equivalent	Dade Behring, Inc.
K013076	SYNCHRON SYSTEMS VANCOMYCIN REAGENT; SYNCHRON SYSTEMS VANCOMYCIN CALIBRATOR	Dec 12, 2001	Substantially Equivalent	Beckman Coulter, Inc.
K983280	VANCOMYCIN EIA ASSAY	Nov 06, 1998	Substantially Equivalent	Diagnostic Reagents, Inc.
K964587	VANCOMYCIN ASSAY OR THE TECHNICON IMMUNO 1 SYSTEM	Jan 13, 1997	Substantially Equivalent	Bayer Corp.
K963267	VANCOMYCIN FLEX REAGENT CARTRIDGE	Sep 13, 1996	Substantially Equivalent	Dade Intl., Inc.
K955851	AXSYM VANCOMYCIN II	May 09, 1996	Substantially Equivalent	Abbott Laboratories
K955716	VANCOMYCIN FPIA REAGENT SET	Feb 16, 1996	Substantially Equivalent	Sigma Diagnostics, Inc.
K953528	ROCHE COBAS-FP REAGENTS FOR VANCOMYCIN	Sep 12, 1995	Substantially Equivalent	Roche Diagnostic Systems, Inc.
K951059	CIBA CORNING ACS VANCOMYCIN IMMUNOASSAY	Jun 19, 1995	Substantially Equivalent	Ciba Corning Diagnostics Corp.
K945125	DUPONT ACA VANCOMYCIN (VANC) METHOD	Mar 10, 1995	Substantially Equivalent	The DU Pont Co.
K940595	AXSYM VANCOMYCIN	Jun 21, 1994	Substantially Equivalent	Abbott Laboratories
K924957	OPUS(R) VANCOMYCIN	Dec 11, 1992	Substantially Equivalent	Pb Diagnostic Systems, Inc.
K901759	COBAS-FP REAGENTS FOR VANCOMYCIN	May 02, 1990	Substantially Equivalent	Roche Diagnostic Systems, Inc.
K900708	MODIFIED ACCUFLUOR VANCOMYCIN REAGENT & CALIBRATOR	Apr 19, 1990	Substantially Equivalent	Innotron of Oregon, Inc.
K892900	ACA VANCOMYCIN (VANC) METHOD	May 22, 1989	Substantially Equivalent	E.I. Dupont DE Nemours & Co., Inc.
K881040	EMIT VANCOMYCIN ASSAY	Apr 19, 1988	Substantially Equivalent	Syva Co.
K874438	STRATUS VANCOMYCIN FLUOROMETRIC ENZYME IMMUNOASSAY	Jan 21, 1988	Substantially Equivalent	Baxter Healthcare Corp
K872579	INNOFLUOR VANCOMYCIN REAGENT SET	Aug 17, 1987	Substantially Equivalent	Innotron of Oregon, Inc.
K822308	VANCOMYCIN FLUORESCENT IMMUNOASSAY	Aug 16, 1982	Substantially Equivalent	American Diagnostic Corp.
K821136	TDX TM STREPTOMYCIN	May 13, 1982	Substantially Equivalent	Abbott Laboratories
K813218	TDX VANCOMYCIN	Dec 08, 1981	Substantially Equivalent	Abbott Laboratories