CONTROL FOR ILLICIT ABUSE DRUGS – LEVELS 1 and 2 (Buprenorphine, Amphetamine, Methamphetamine, MDMA, MDA, MDE, MBDB, Ketamine, Diacetylmorphine, Ephedrine, Pseudoephedrine, Methorphan, 6-Monoacetylmorphine, delta-9-THC, Morphine, Cannabidiol [CBD], Aminophenazone, Benzocaine, Diltiazem, Ibuprofen, Hydroxyzine, Levamisole, Lidocaine, Naloxone, Nicotine, Noscapine, Paroxetine, Procaine, Procainamide, Sulphamethoxazole, Trimethoprim, Tropacocaine, Paracetamol, Caffeine, Cocaine, Methadone, Phenacetin, Acetylsalicylic Acid)

Code LC20019

OBJECTIVE These controls in hair are used to calibrate the chromatographic system in quantitative determination of analytes in them.

STORAGE AND STABILITY Once you open the vial, withdrawn the volume needed, recap and stored at -20 ° C. Stable 6 months. Do not use after the expiration date.

PRECAUTIONS These controls in human matrix should be treated with care and treated as potentially infectious.

003 July Jan 2020 2021

PACKAGING AVAILABLE:

- LC20019 CONTROLS FOR ILLICIT ABUSE DRUGS 2 x 4 x 1,5 ml

Release N° 00 2 Ma y 2019

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CONCENTRATIONS CODE LC20019

003 July Jan 2020 2021

CONCENTRATIONS IF THE SAMPLES TO BE TREATED ARE STEP 4a OF THE METHOD OF USE LC20000:

Control 1 Analyte

MEDIUM VALUE RANGE

Buprenorphine, Amphetamine, Methamphetamine, MDMA, MDA, MDE, MBDB, Ketamine, Diacetylmorphine, Ephedrine, Pseudoephedrine, Methorphan, 6-Monoacetylmorphine, delta-9-THC, Morphine, CBD, Aminophenazone, Benzocaine, 7,5 ng/ml 5,25 – 9,75 ng/ml Diltiazem, Ibuprofen, Hydroxyzine, Levamisole, Lidocaine, Naloxone, Nicotine, Noscapine, Paroxetine, Procaine, Procainamide, Sulphamethoxazole, Trimethoprim, Tropacocaine

Paracetamol, Caffeine, Cocaine, Methadone, Phenacetin, Acetylsalicylic 25 ng/ml 17,5 – 32,5 ng/ml Acid

Control 2 Analyte

MEDIUM VALUE RANGE

Buprenorphine, Amphetamine, Methamphetamine, MDMA, MDA, MDE, MBDB, Ketamine, Diacetylmorphine, Ephedrine, Pseudoephedrine, Methorphan, 6-Monoacetylmorphine, delta-9-THC, Morphine, CBD, Aminophenazone, Benzocaine, 75 ng/ml 52,5 – 97,5 ng/ml Diltiazem, Ibuprofen, Hydroxyzine, Levamisole, Lidocaine, Naloxone, Nicotine, Noscapine, Paroxetine, Procaine, Procainamide, Sulphamethoxazole, Trimethoprim, Tropacocaine

Paracetamol, Caffeine, Cocaine, Methadone, Phenacetin, Acetylsalicylic 100 ng/ml 70 – 130 ng/ml Acid

Release N° 00 2 Ma y 2019 2

CONCENTRATIONS IF THE SAMPLES TO BE TREATED ARE STEP 4b OF THE METHOD OF USE LC20000:

Control 1 Analyte

MEDIUM VALUE RANGE

Buprenorphine, Amphetamine, Methamphetamine, MDMA, MDA, MDE, MBDB, Ketamine, Diacetylmorphine, Ephedrine, Pseudoephedrine, Methorphan, 6-Monoacetylmorphine, delta-9-THC, Morphine, CBD, Aminophenazone, Benzocaine, 1,5 ng/ml 1,05 – 1,95 ng/ml Diltiazem, Ibuprofen, Hydroxyzine, Levamisole, Lidocaine, Naloxone, Nicotine, Noscapine, Paroxetine, Procaine, Procainamide, Sulphamethoxazole, Trimethoprim, Tropacocaine

Paracetamol, Caffeine, Cocaine, 5 ng/ml Methadone, Phenacetin, Acetylsalicylic 3,5 – 6,5 ng/ml Acid

Control 2 Analyte

MEDIUM VALUE RANGE

Buprenorphine, Amphetamine, Methamphetamine, MDMA, MDA, MDE, MBDB, Ketamine, Diacetylmorphine, Ephedrine, Pseudoephedrine, Methorphan, 6-Monoacetylmorphine, delta-9-THC, Morphine, CBD, Aminophenazone, Benzocaine, 15 ng/ml 10,5 – 19,5 ng/ml Diltiazem, Ibuprofen, Hydroxyzine, Levamisole, Lidocaine, Naloxone, Nicotine, Noscapine, Paroxetine, Procaine, Procainamide, Sulphamethoxazole, Trimethoprim, Tropacocaine

Paracetamol, Caffeine, Cocaine, Methadone, Phenacetin, Acetylsalicylic 20 ng/ml 14 – 26 ng/ml Acid

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* The procedures for production and validation / quality control of every batch shall be performed using the chromatographic method LC / MS / MS validated according to international guidelines of the Food and Drug Administration (FDA-May 2001) and the International Conference of Harmonisation of technical requirements for registration of pharmaceuticals for human use (ICH-Q2-R1-Nov 2005). The mean value and standard deviation were obtained during the validation phase of batch processing for level four bottles in duplicate.

This product fulfills all the requirements of Directive 98/79/EC of 27/10/1998 and Dl.ivo n.332 of 08/09/2000 on in vitro diagnostic medical devices (IVD). The declaration of conformity is available upon request.

FOR IN VITRO DIAGNOSTIC USE ONLY

produced by

EUREKA srl – LAB DIVISION , Via Enrico Fermi 25, 60033 Chiaravalle (AN) ITALY Tel. + 39 071 74 50 790 Fax. + 39 071 74 96 579 [email protected] , [email protected] www.eurekaone.com, www.eurekakit.com

Release N° 00 2 Ma y 20 19

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