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TesTcup II and CupKit products are in vitro diagnostics tests intended for professional use for the qualitative detection of drug or drug metabolite in urine at or above the stated cutoff concentrations: Cutoff Concentrations: - Amphetamines: 1000 ng/mL - Benzodiazepines: 200 ng/mL - Cocaine metabolite: 300 ng/mL - Methamphetamine: 500 ng/mL - Methamphetamine: 300 ng/mL - Morphine: 300 ng/mL - Morphine (M2K): 2000 ng/mL - Phencyclidine (PCP): 25 ng/mL - Tetrahydrocannabinols: 50 ng/mL TesTcup II and CupKit products provide only a preliminary analytical test result. A more specific alternate chemical method must be used in order to obtain a confirmed analytical result.

The OnTrak TesTcup II and OnSite Cupkit assays contained in this submission are in vitro diagnostic tests intended for professional use in the qualitative detection of amphetamines (d,1-amphetamine 1000 ng/mL), benzodiazepines (oxazepam 200 ng/mL), cocaine metabolite (benzoylecgonine 300 ng/mL), methamphetamine (d-methamphetamine 500 ng/mL), and methamphetamine (d-methamphetamine 300 ng/mL), morphine (morphine 300 ng/mL), and morphine (morphine 2000 ng/mL), PCP (phencyclidine 25 ng/mL) and THC (11-nor-Δ'-THC-9-carboxylic acid 50 ng/mL). The assays are based on the principle of microparticle capture inhibition. The test relies on the competition between drug, which may be present in the urine being tested, and drug conjugate immobilized on a membrane in the test chamber. Urine is collected directly in the test cup provided. The drug profile card is placed in the samples by inserting it into the lid holder, then securing the lid onto the cup. Urine is drawn in the profile card by capillary action and reacts with antibody-coated microparticles and drug conjugate present on the membrance. In the absence of drug, the antibody is free to interact with the drug conjugate, causing the formation of a blue band. When drug is present in the specimen, it binds to the antibody-coated microparticles. If sufficient drug is present, the microparticles are inhibited from binding the drug conjugate and no blue band is formed at the result window. A preliminary positive ("non-negative") result is the absence of a blue band. An additional antibody/antigen reaction occurs at the "VALID" area. The "VALID" blue band forms when antibodies, which are imbedded in the reagent membrane, interact with and bind to the antigen on the blue microparticles.

The OnTrak TesTcard menus are various combinations of the different drugs hat are listed below. The TesTcard products are in vitro diagnostic tests for the qualitative detection of drug or drug metabolite in urine. The TesTcard devices simultaneously test for the presence of multiple drugs or drug metabolites. The TesTcard profile (cutoff) consists of the following: Amphetamines (d,l-amphetamine): 1000 ng/mL, Barbiturates (secobarbital): 200 ng/mL, Benzodiazepines (oxazepam): 100 ng/mL, Cocaine metabolite (benzoylecgonine): 300 ng/mL, Methamphetamine (d-methamphetamine): 500 ng/mL, Morphine (morphine): 300 ng/mL, PCP (phencyclidine): 25 ng/mL, Tricyclic Antidepressants (TCA)(Imipramine): 1000 ng/mL, THC (11-nor-delta9-THC-9-carboxylic acid): 50 ng/mL. AND/OR TesTcard products provide only preliminary analytical test result. A more specific alternate test method must be used in order to obtain a confirmed analytical result. Prescription Use V (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 807 Subpart C)

The OnTrak TesTcard assays contained in this submission are in vitro diagnostic tests intended for the qualitative detection of drug or drug metabolite in urine. The TesTcard devices simultaneously test for the presence of multiple drugs or drug metabolites. The TesTcard profile (cutoff) consists of amphetamines (d,l-amphetamine 1000 ng/mL), barbiturates (secobarbital 200 ng/mL), benzodiazepines (oxazepam 100 (benzoylecgonine cocaine metabolite ng/mL). methamphetamine (d-methamphetamine 500 ng/mL), morphine (morphine 300 ng/mL), PCP (phencyclidine 25 ng/mL), tricyclic antidepressants (TCA) (imipramine 1000 ng/mL) and THC (11-nor-A-THC-9-carboxylic acid 50 ng/mL). The TesTcard assays are based on the principle of microparticle capture inhibition. The test relies on the competition between drug, which may be present in the urine being tested, and drug conjugate immobilized on a membrane in the test chamber. When the TesTcard contacts the urine sample, the sample is absorbed into the TesTcard sample pad. The absorbed sample travels through the reagent strips contained in the device by capillary action. In the reagent strip, the sample rehydrates and mobilizes antibody-coated blue microparticles. The microparticle-urine suspension continues to migrate through the reagent strip and comes in contact with the immobilized drug conjugates. In the absence of drugs in the urine, the antibody coated microparticles bind to the drug conjugates and blue bands are formed in the result areas. When drugs are present in the specimen, they bind to the respective antibody-coated microparticles. If sufficient drug is present, the microparticles are inhibited from binding the appropriate drug conjugate and no blue band is formed in the result area below the drug name. A positive specimen causes the membrane to remain white. An additional antibody/antigen reaction occurs at the "VALID" area. The "TEST VALID" blue band forms when antibodies imbedded in the reagent membrane bind to the antigen on the blue microparticles. The presence of the "TEST VALID" band indicates that the test has completed, the reagents in the "TEST VALID" area are valid, and the results are ready to interpret.

On Trak TesTcard 9 product, is an in vitro diagnostic test intended for use by health care professionals only for the qualitative detection of drug or drug metabolites in urine. On Trak TesTcard 9 simultaneously tests for the presence of multiple drugs or drug metabolites at or above the stated concentrations. Cutoff Concentrations: Amphetamines 1000 ng/mL Barbiturates 200 ng/mL Benzodiazepines 100 ng/mL Cocaine metabolite 300 ng/mL Methamphetamine 500 ng/mL Morphine 300 ng/mL Phencyclidine (PCP) 25 ng/mL Tricyclic Antidepressants (TCA) 1000 ng/mL Tetrahydrocannabinols (THC) 50 ng/mL

On Trak TesTcard 9 product provides only a preliminary analytical test result. A more specific alternate chemical method must be used in order to obtain a confirmed analytical result. Gas chromatography/ mass spectrometry (GC/MS) is the preferred confirmation method. Clinical consideration and professional judgment should be applied to any drug abuse test result, particularly when preliminary positive results are used.

TesTcup II and CupKit products are in vitro diagnostics tests intended for professional use for the qualitative detection of drugs or drug metabolites in urine at or above the stated cutoff concentrations. Cutoff Concentrations: Amphetamines: 1000 ng/mL Benzodiazepines: 200 ng/mL Cocaine metabolite: 300 ng/mL Methamphetamine: 500 ng/mL Morphine: 300 ng/mL Morphine (M2K): 2000 ng/mL Phencyclidine (PCP): 25 ng/mL Tetrahydrocannabinols (THC): 50 ng/mL TesTcup II and CupKit products provide only a preliminary analytical test result. A more reliable analytical method must be used in order to obtain a confirmed analytical result.

The OnTrak TesTcup II and OnSite Cupkit assays contained in this submission are in vitro diagnostic tests intended for professional use for the qualitative detection of amphetamines (d,l-amphetamine 1000 ng/mL), benzodiazepines (oxazepam 200 ng/mL), cocaine metabolite (benzoylecgonine 300 ng/mL), methamphetamine (d-methamphetamine 500 ng/mL), morphine (morphine 300 ng/mL) and morphine 2000 (morphine 2000 ng/mL), PCP (phencyclidine 25 ng/mL), and THC (11-nor-Δ 9 -THC-9-carboxylic acid 50 ng/mL). The assays are based on the principle of microparticle capture inhibition. The test relies on the competition between drug, which may be present in the urine being tested, and drug conjugate immobilized on a membrane in the test chamber. Urine is collected directly in the test cup provided. The drug profile card is placed in the samples by inserting it into the lid holder, then securing the lid onto the cup. Urine is drawn in the profile card by capillary action and reacts with antibody-coated microparticles and drug conjugate present on the membrane. In the absence of drug, the antibody is free to interact with the drug conjugate, causing the formation of a blue band. When drug is present in the specimen, it binds to the antibody-coated microparticles. If sufficient drug is present, the microparticles are inhibited from binding the drug conjugate and no blue band is formed at the result window. A preliminary positive ("non-negative" result is the absence of a blue band). An additional antibody/antigen reaction occurs at the "VALID" area. The "VALID" blue band forms when antibodies, which are imbedded in the reagent membrane, interact with and bind to the antigen on the blue microparticles.

OnTrak TesTcup and OnTrak TesTstik products, as listed below, are in vitro diagnostics tests On Flax Tes I cup and On Frak Test realitative detection of drugs in urine at or above the stated cutoff concentrations. OnTrak TesTcup and OnTrak TesTstik products provide only a preliminary analytical test result. On Frax Test cap and On Flair For roler por roler to obtain a confirmed analytical result.

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