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510(k) Data Aggregation
K Number
K192517Device Name
Psychemedics Microplate EIA for Cotinine in Hair
Manufacturer
Psychemedics Corporation
Date Cleared
2020-04-22
(222 days)
Product Code
MKU
Regulation Number
862.3220Why did this record match?
Product Code :
MKU
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Psychemedics Microplate EIA For Cotinine in Hair is an in vitro diagnostic device for the qualitative detection of cotinine in human head and body hair as an aid in the detection of cotinine after use or exposure to tobacco products. The assay is intended for a single site and uses a cutoff calibrator of 200 pg cotinine/mg hair. This device is intended exclusively for Psychemedics use only and is not intended for sale to anyone.
The Psychemedics Microplate EIA For Cotinine in Hair provides only a preliminary analytical test result. A more specific alternate chemical method must be used to obtain a confirmed analytical result. Liquid Chromatography/Mass spectrometry/Mass spectrometry (LC/MS/MS) is the confirmatory method used by Psychemedics Corporation. The LC/ MS/MS analysis uses a cutoff, after extensive washing of 100 pg cotinine/mg hair with presence of hydroxycotinine at or above 10 pg/mg hair.
Device Description
The Psychemedics Microplate EIA For Cotinine in Hair consists of two parts; a pre-analytical hair treatment procedure (to convert the solid matrix of hair to a measurable liquid matrix) and the screening assay, the Psychemedics Microplate EIA for Cotinine. The screening portion of the test system consists of (1) microplate wells coated with cotinine conjugated to bovine serum albumin (BSA), polyclonal rabbit anti-cotinine, goat antirabbit secondary antibody conjugated to HRP (horseradish peroxidase), substrate [3, 3', 5, 5' tetramethylbenzidine (TMB)], HCl to acidify (and stop the reaction), and wash buffer for washing the plates. Absorbance in the wells is read with a microplate reader.
Liquid Chromatography/Mass spectrometry/Mass spectrometry (LC/MS/MS) is the confirmatory method used by Psychemedics Corporation. The LC/MS/MS analysis uses a cutoff, after extensive washing of the hair, of 100 pg cotinine/mg hair with presence of hydroxycotinine at or above 10 pg/mg hair.
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K Number
K192299Device Name
LZI Cotinine II Enzyme Immunoassay
Manufacturer
Lin-Zhi International, Inc.
Date Cleared
2019-11-21
(90 days)
Product Code
MKU
Regulation Number
862.3220Why did this record match?
Product Code :
MKU
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The LZI Cotinine II Enzyme Immunoassay is intended for the quantitative determination of cotinine in human urine at the cutoff value of 200 ng/mL when calibrated against cotinine. The assay is intended as an aid in the detection of cotinine after use or exposure to tobacco products. The assay is designed for prescription use with a number of automated clinical chemistry analyzers.
The semi-quantitative mode is for purposes of (1) enabling laboratories to determine an appropriate dilution of the specimen for confirmation by a confirmatory method such as gas or liquid chromatography/mass spectrometry (GC/MS or LC/MS) or (2) permitting laboratories to establish quality control procedures.
The assay provides only a preliminary analytical result. A more specific alternative chemical method (e.g., gas or liquid chromatography and mass spectrometry) must be used in order to obtain a confirmed analytical result. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary test result is positive.
Device Description
The LZI Cotinine II Enzyme Immunoassay is a homogeneous enzyme immunoassay with readyto-use liguid reagents. The assay is based on competition between drug in the sample and drug labeled with the enzyme glucose-6-phosphate dehydrogenase (G6PDH) for a fixed amount of antibody in the reagent. Enzyme activity decreases upon binding to the antibody, and the drug concentration in the sample is measured in terms of enzyme activity. In the absence of drug in the sample, cotinine-labeled G6PDH conjugate is bound to antibody, and the enzyme activity is inhibited. On the other hand, when free drug is present in the sample, antibody would bind to free drug; the unbound cotinine-labeled G6PDH then exhibits its maximal enzyme activity. Active enzyme converts nicotinamide adenine dinucleotide (NAD) to NADH, resulting in an absorbance change that can be measured spectrophotometrically at 340 nm.
The LZI Cotinine II Enzyme Immunoassay is a kit comprised of two reagents, an R1 and R2 which are bottled separately but sold together within the kit.
The R1 solution contains mouse monoclonal anti-cotinine antibody, glucose-6-phosphate (G6P) nicotinamide adenine dinucleotide (NAD), stabilizers, and sodium azide (0.09 %) as a preservative. The R2 solution contains glucose-6-phosphate dehydrogenase (G6PDH) labeled with cotinine in buffer with sodium azide (0.09 %) as a preservative.
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K Number
K062565Device Name
STATUS DS NICOTINE, ACCUSIGN NICOTINE, BIOSIGN NICOTINE
Manufacturer
PRINCETON BIOMEDITECH CORP.
Date Cleared
2007-02-20
(173 days)
Product Code
MKU
Regulation Number
862.3220Why did this record match?
Product Code :
MKU
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Immunoassay for the qualitative detection of cotinine, a major metabolite of nicotine, at the cut-off of 500 ng/mL in human urine. Status DS ™ Nicotine is used as an aid in the detection of cotinine after use of tobacco products or other products containing nicotine. For In vitro Diagnostic Use. The Status DSTM Nicotine test provides only a preliminary analytical result. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. Gas chromatography, mass spectrometry (GC/MS) is the preferred confirmatory method.
Device Description
Status DS'" Nicotine is a simple one step immunochromatographic test for the rapid, qualitative detection of cotinine, a major metabolite of nicotine.
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K Number
K021944Device Name
COZART EIA COTININE URINE KIT
Manufacturer
COZART BIOSCIENCE LTD.
Date Cleared
2003-05-14
(335 days)
Product Code
MKU
Regulation Number
862.3220Why did this record match?
Product Code :
MKU
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Cozart Bioscience EIA Cotinine Urine Kit is intended for laboratory based testing in clinical and analytical laboratories and for insurance assessment. It provides qualitative screening results for Cotinine in human urine at a cut-off concentration of 500ng/ml. The Cozart EIA Cotinine Urine Kit acts as an aid in the detection of cotinine after use of tobacco products or other products containing nicotine.
This assay is for professional use only and provides only a preliminary analytical test result. Clinical consideration and professional judgement must be applied to any drug of abuse test result, particularly in evaluating a preliminary positive result. In order to obtain a more confirmed analytical result a more specific alternative chemical method is needed. Gas Chromatography/Mass Spectrometry (GC/MS) is the preferred confirmatory method.
Device Description
The Cozart EIA Cotinine Urine Kit test is a competitive ELISA for the detection of Cotinine in human urine. The kit supplies the following reagents - a microtitre plate coated with antibody, enzyme conjugate reagent, wash buffer, substrate solution, stop solution and four calibrators (0, 50, 500 and 5000ng/ml Cotinine in human urine).
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K Number
K974534Device Name
MICRO-PLATE COTININE EIA
Manufacturer
ORASURE TECHNOLOGIES, INC.
Date Cleared
1998-05-18
(167 days)
Product Code
MKU
Regulation Number
862.3220Why did this record match?
Product Code :
MKU
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The STC Cotinine Micro-Plate EIA is intended for use in the qualitative and semi-quantitative determination of cotinine in serum and plasma. For In Vitro Diagnostic Use.
Device Description
Not Found
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K Number
K974234Device Name
MICRO-PLATE COTININE EIA
Manufacturer
ORASURE TECHNOLOGIES, INC.
Date Cleared
1998-05-14
(183 days)
Product Code
MKU
Regulation Number
862.3220Why did this record match?
Product Code :
MKU
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The STC Cotinine Micro-Plate EIA is intended for use in the qualitative and semi-quantitative determination of cotinine in oral fluid collected with the EpiScreen™ Oral Specimen Collection Device. For In Vitro Diagnostic Use.
Device Description
Not Found
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K Number
K972481Device Name
AUTO-LYTE COTININE EIA
Manufacturer
ORASURE TECHNOLOGIES, INC.
Date Cleared
1997-10-21
(111 days)
Product Code
MKU, DAT
Regulation Number
862.3220Why did this record match?
Product Code :
MKU
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The STC Auto-Lyte® Cotinine EIA is a homogeneous immunoassay intended for the qualitative and semiquantitative analysis of cotinine in human urine. Cotinine is the major metabolite of nicotine, and the STC kit is useful in the detection of cotinine after ingestion of or exposure to nicotine. For In Vitro Diagnostic Use.
Device Description
Not Found
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